Measles at Baseline.|6 weeks Postvaccination in subjects receiving ProQuad™ concomitantly with a fourth dose of Prevnar™ and in subjects receiving ProQuad™ alone|Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.||Participants|||Number
172103|NCT00107900|Secondary|Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results|Intent to Treat (ITT) population|end of treatment|ITT population||seconds||Standard Deviation|Mean
172106|NCT00107900|Primary|Prevention of Venous Thromboembolism (VTE)|"The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment (approximately 2 weeks post surgery).~Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography"|2 weeks|modified ITT population||percentage of patients with event||90% Confidence Interval|Number
172107|NCT00109031|Secondary|Number of Participants With WHO Grade 4 Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set||participants|||Number
172108|NCT00109031|Secondary|Duration of WHO Grade 2, 3 or 4 Oral Mucositis|"The duration of grade 2, 3 or 4 oral mucositis (OM) was calculated as the number of days from the onset of grade 2, 3 or 4 OM (first time a WHO grade 2, 3 or 4 was observed) to the day when WHO grade 2 - 4 OM was resolved (first time WHO grade less than 2 was observed after last WHO grade 2, 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 2, 3 or 4 during the study.~OM was evaluated using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible."|Up to Day 28|Primary analysis set with available OM assessment data||days||Standard Deviation|Mean
172109|NCT00109031|Secondary|Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set||participants|||Number
172110|NCT00109031|Secondary|Number of Participants With Parenteral or Transdermal Opioid Analgesic Use|Includes nonprophylactic intravenous opioid analgesics (fentanyl, morphine, morphine sulphate, hydromorphone, meperidine) and transdermal opioid analgesics (fentanyl patch) for the indication of oral mucositis and dysphagia.|Up to Day 28|Primary analysis set||participants|||Number
172111|NCT00109031|Secondary|Area Under the Curve (AUC) of Mouth and Throat Soreness Score|"The Oral Mucositis Daily Questionnaire (OMDQ) is a self-reported tool that evaluates overall health, mouth and throat soreness (MTS) and activity limitations due to MTS. The OMDQ was completed once daily beginning with the first day of study drug administration through Day 28. The area under the curve of mouth and throat soreness score was assessed from the question How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness). A higher value in MTS AUC indicates worse self-assessed MTS."|From the first day of study drug administration through Day 28|Primary analysis set with available MTS data||MTS score * days||Standard Deviation|Mean
172112|NCT00109031|Secondary|Duration of Severe Oral Mucositis (WHO Grade 3 and 4)|The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.|Up to Day 28|Primary analysis set||days||Standard Deviation|Mean
172113|NCT00109031|Primary|Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) daily during hospitalization and daily thereafter until severe OM returned to grade ≤ 2. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Day 28|Primary analysis set||participants|||Number
172114|NCT00109005|Secondary|Evaluate Effects of Lenalidomide on Pathways|Tissue will be obtained to evaluate the effects of lenalidomide on pathways thought to be modulated by lenalidomide.|Baseline and at the end of treatment cycles 3 and 6. Every 21 day supply of lenalidomide with a 7 day rest (total of 28 days) will be considered a cycle of therapy.|This outcome measure was not analyzed because the investigator left the institution.|||||
172115|NCT00109005|Secondary|Determine Dose Level With Superior Efficacy and Acceptable Toxicity|The most efficacious dose (with greater number of responses) with acceptable toxicity profile will be considered for use in subsequent trials. iI the number of responses is tied, then toxicity criteria (Common Terminology criteria (CTC) v3.0) will be used to select the preferred dose.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.|||||
172116|NCT00109005|Secondary|Determine Pharmacokinetics of Lenalidomide at Two Dose Levels: 5 mg and 25 mg|Plasma samples will be obtained and plasma concentrations will be determined by a reversed-phase high-performance liquid chromatography (HPLC) assay using mass spectrometry (MS) detection.|Prior to treatment on cycle 1, day 1 and then on cycle 1, day 1 at 0.25, 0.5, 1, 2, 4, 6, 9 and 12 hours. Cycle 1, day 2 at 24 hours.|This outcome measure was not analyzed because the investigator left the institution.|||||
172117|NCT00109005|Secondary|Overall Survival|Date of on-study to the date of death from any cause or last follow up.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.|||||
172118|NCT00109005|Secondary|Progression Free Survival|Time interval from start of treatment to documented evidence of disease progression.|up to 2 years|This outcome measure was not analyzed because the investigator left the institution.|||||
172119|NCT00109005|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|24 months|||Participants|||Number
177804|NCT00006178|Secondary|Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)|measure at 12 months after intervention|12 months after intervention|||mL/min||Standard Deviation|Mean
172120|NCT00109005|Primary|Clinical Responses in Patients With Metastatic Ocular Melanoma|Clinical response is assessed by the Response Evaluation Criteria for Adverse Events in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|12 months|"Response data was combined for this outcome measure. Results are available for the combined cohorts only.~Sixteen out of seventeen patients were eligible for response assessments."||Participants|||Number
172121|NCT00108953|Secondary|Percentage of Participants for Whom Disease Control Was Achieved|Participants with disease control: those who have as best response complete response (CR), partial response (PR) or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease) according to Response Evaluation Criteria in Solid Tumors (RECIST)|from date of randomization to end of treatment plus 30 days|The ITT population, primary population for efficacy analysis, includes all randomized patients.||Percentage of participants|||Number
172122|NCT00108953|Secondary|Time to Response (TTR)|Time from date of randomization to date of first objective response (complete response [CR] or partial response [PR]) is documented and confirmed according to RECIST criteria|from date of randomization until 3 years later at end of study|The ITT population, primary population for efficacy analysis, includes all randomized patients.||days||Full Range|Median
172123|NCT00108953|Secondary|Duration of Response|Time from date of first objective response (complete response [CR] or partial response [PR]) to date progression is first documented (as defined per independent central radiological assessment) or death, whichever occurs first|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.||days||Full Range|Median
172124|NCT00108953|Secondary|Time to Symptomatic Progression (TTSP)|Time from date of randomization to date of first documented symptomatic progression defined by Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index-8 (FHSI-8) assessment|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.||days||95% Confidence Interval|Median
172125|NCT00108953|Secondary|Percentage of Participants in Each Category of Best Tumor Response|Percentage of participants with complete or partial response (CR or PR) confirmed according to Response Evaluation Criteria in Solid Tumors (RECIST) and achieved during treatment or 30 days after end of treatment. CR: disappearance of all clinical and radiological tumor lesions. PR: at least 30% decrease in sum of the longest diameters of tumor lesions. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.|achieved during treatment or within 30 days after termination of active therapy|The ITT population, primary population for efficacy analysis, includes all randomized patients.||Percentage of participants|||Number
172126|NCT00108953|Secondary|Progression Free Survival (PFS)|Time from the date of randomization to the date of the first documented radiological progression (as defined per independent central radiological assessment) or death, whichever occurs first|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients.||days||95% Confidence Interval|Median
172127|NCT00108953|Secondary|Overall Survival|The time from date of randomization to date of death|from date of randomization of the first patient until 3 years later|The ITT population, primary population for efficacy analysis, includes all randomized patients. The table below gives the lower and upper limit of the confidence interval; 999999999 = not estimable.||days||95% Confidence Interval|Median
172128|NCT00108953|Primary|Time to Progression (TTP)|TTP was defined as the time from randomization to radiological disease progression by independent assessment.|from date of randomization of the first patient until 3 years later|The intent-to-treat (ITT) population, primary population for efficacy analysis, includes all randomized patients.||days||95% Confidence Interval|Median
172129|NCT00108862|Secondary|Percent of Participants Whose HIV Viral Load Was Less Than 400 Copies/mL at Week 48.|All eligible participants were included in the analysis. Participants who were lost-to-follow-up (LFU) prior to week 48 or who were alive with a HIV viral load at least 400 copies/mL were grouped separately those those who died or who had HIV viral loads below 400 copies/mL. Participants missing HIV viral loads at week 48 were coded as LFU in this analysis. Percents were calculated with associated standard errors.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
172130|NCT00108862|Secondary|Percent of Participants With HIV IRIS.|All eligible participants were included in this analysis. The percent of participants with HIV-associated immune reconstitution inflammatory syndrome (IRIS) was calculated with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
172131|NCT00108862|Secondary|Percent of Participants With MTB IRIS.|All eligible participants were included in this analysis. The percent of participants with Mycobacteria tuberculosis (MTB)-associated immune reconstitution inflammatory syndrome (IRIS) was calculated with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
172132|NCT00108862|Secondary|Percent of Participants Whose CD4 Increased by at Least 100 Cells/mm^3 Between Baseline and Week 48.|All eligible participants were included in the analysis. Participants who were lost-to-follow-up (LFU) prior to week 48 or who were alive with a CD4 cell count increase of less than 100 cells/mm^3 were grouped separately those who died or whose CD4 cell count increased by at least 100 cells/mm^3. Participants missing CD4 cell counts at week 48 were coded as LFU in this analysis. The percents were calculated with associated standard errors.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
172174|NCT00107653|Secondary|Number of Participants With Premature Withdrawals Due to Adverse Events or Laboratory Abnormalities|The table below includes participants with premature withdrawals due to adverse events or laboratory abnormalities.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.||Participants|||Number
172133|NCT00108862|Secondary|Percent of Participants With Confirmed or Probable Tuberculosis (TB) Whose TB Resolved, or Who Required TB Treatment Through the End of Follow-up, or Died, or Were Lost to Follow-up.|TB treatment outcome was assessed in the 800 eligible participants who had confirmed or probable TB at study entry. The sites determined if the TB was resolved. If TB was not resolved, TB treatment outcome status was determined based on whether TB treatment was ongoing at the last study visit; if the participant died while TB treatment was ongoing; or if the participant was lost to follow-up, withdrew consent, or other reason for lacking TB resolution status. Percents were calculated with associated standard errors.|Through week 48|Participants with confirmed or probable TB at study entry were included in this analysis. Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
172134|NCT00108862|Secondary|Percent of Participants Who Interrupted or Discontinued at Least One Tuberculosis (TB) Medication Due to Toxicity.|All eligible participants were included in this analysis. The percent of participants who interrupted at least one TB medication for more than one day due to toxicity or discontinued at least one TB medication due to toxicity was calculated with an associated standard error.|Through week 48|||percent of participants||95% Confidence Interval|Number
172135|NCT00108862|Secondary|Percent of Participants With Culture-confirmed Tuberculosis (TB) Who Survived Without AIDS Progression.|This analysis was based on 374 participants with culture-confirmed TB at entry. The percent with culture-confirmed TB surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
172136|NCT00108862|Secondary|Time to First New AIDS-defining Illness or Death.|All eligible participants were included in this analysis. Weeks from randomization to first new AIDS-defining illness or death was analyzed using a stratified Cox proportional hazards regression model. The stratification was by screening CD4 cell count: <50 cells/mm3 versus =>50 cells/mm3.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||weeks||95% Confidence Interval|Number
172137|NCT00108862|Secondary|Percent of Participants Reporting a Grade 3 or 4 Adverse Event or Laboratory Abnormality|All eligible participants were included in this analysis. The percent of participants whose highest reported grade of adverse events and laboratory abnormalities was Grade 3 or 4 was calculated with an associated standard error, where Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life threatening/disabling, and Grade 5=death.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
172138|NCT00108862|Other Pre-specified|Percent of Participants in the Greater Than or Equal to 50 Cells/mm^3 CD4 Stratum Who Survived Without AIDS Progression.|Participants were included as described in the Outcome Measure Description for the Primary Outcome, except that only those in the =>50 CD4 stratum were analyzed. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
172139|NCT00108862|Other Pre-specified|Percent of Participants in the Less Than 50 Cells/mm^3 CD4 Stratum Who Survived Without AIDS Progression.|Participants were included as described in the Outcome Measure Description for the Primary Outcome, except that only those in the <50 CD4 stratum were analyzed. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
172140|NCT00108862|Primary|Percent of Participants Who Survived Without AIDS Progression.|As this was a study of the strategy of providing antiretroviral therapy (ART) during the initial treatment of TB versus deferring ART until TB was treated for 8-12 weeks, all eligible participants randomized were followed for 48 weeks, whether they started ART as scheduled, whether they started ART at all, or even if the participant did not have TB and discontinued TB treatment. The percent surviving without a new AIDS-defining illness was calculated using a Kaplan-Meier estimator with an associated standard error.|Through week 48|Numbers presented use the intent-to-treat approach (i.e., ignoring changes from randomized treatment strategy).||percent of participants||95% Confidence Interval|Number
172141|NCT00108732|Secondary|The Difference Between PSA Slopes Before and After Treatment|PSA slopes were assessed by multiple PSA values obtained prior to registration and during treatment. Only patients who completed at least 3 months of treatment were included in this analysis. The PSA slopes were calculated by a piecewise linear model using the three or four PSA values obtained prior to registration and PSA measurements obtained every 4 weeks for the first six months of treatment. Natural log transformed PSA levels were used in this analysis, and the difference between PSA slopes before and after treatment was calculated.|Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months|Only 31 patients who completed at least 3 months of treatment were included in this analysis.||log PSA/month||Full Range|Median
172142|NCT00108732|Secondary|Difference Between Day 4 PSA Level and Day 15 PSA Level|PSA level was assessed on Day 4 and Day 15 of cycle 1, and a comparison between the two measurements was done.|Assessed at day 4 and day 15 of cycle 1|Only 22 patients with both day 4 and day 15 PSA levels available were included in this analysis.||ng/mL||Full Range|Median
172143|NCT00108732|Secondary|Proportion of Patients With PSA Response|"PSA response is defined as complete biochemical response or partial response.~Complete Response:~A PSA < 0.2 ng/mL confirmed by a repeat PSA one month later is considered a complete biochemical response for patients with prior radical prostatectomy. A PSA < 1 ng/mL on three separate occasions taken at least one month apart is considered a complete biochemical response in patients with radiation therapy only.~Partial Response:~A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later."|Assessed monthly during the first 24 weeks and then every 3 months for a maximum total of 24 months|Only eligible and treated patients in step I are included in this analysis.||Proportion of patients||90% Confidence Interval|Number
172325|NCT00106938|Primary|Composite of Any Death, Stroke, and Myocardial Infarction (MI) Within 30 Days Post-index Procedure|Major adverse events = Composite of any stroke, myocardial infarction and death during the 30-day post-procedural period.|0 to 30 days|||percentage of participants|||Number
172144|NCT00108732|Primary|Proportion of Patients Free of PSA Progression at 6 Months (Prior to the Start of Androgen Ablation)|"For patients who achieved a > 50% decline in PSA, an increase in PSA value by 50% over the nadir, confirmed by a second PSA two weeks later is considered progressive disease. The PSA rise must be at least 5 ng/mL or back to pretreatment baseline, whichever is greater.~Changes in PSA below 5 ng/mL will not be considered assessable for progression.~For patients whose PSA has not decreased by 50%, an increase in PSA value > 50% of baseline (on trial) or nadir PSA, whichever is lower, confirmed by a repeat PSA two weeks later is considered progressive disease. The PSA must have risen by at least 5 ng/mL."|Assessed at 6 months|Only eligible and treated patients in step I are included in this analysis.||Proportion of patients||90% Confidence Interval|Number
172145|NCT00108628|Secondary|Clinician-Administered PTSD Scale (CAPS)|Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms.|Baseline and 1 month post-treatment|||units on a scale||Standard Deviation|Mean
172146|NCT00108628|Secondary|SF-36 Mental Component|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best)."|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
172147|NCT00108628|Secondary|SF-36 Physical Component|"The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best)."|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
172148|NCT00108628|Secondary|Beck Depression Inventory|Twenty-one items are rated on a 4-point scale. Total scores range from zero to 63, with higher scores indicating more severe depression.|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
172149|NCT00108628|Secondary|PTSD Military Checklist|Seventeen items indicating the 17 DSM-IV criteria for PTSD are rated on a 5-point scale, from 1 to 5. Scores range from 17 to 85, with a higher score indicating greater symptom severity.|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
172150|NCT00108628|Secondary|Nightmare Effects Survey|This self-report questionnaire assesses psychosocial impairment attributed to nightmares. Eleven self-report questions are rated on a scale of zero to four. The individual scores are summed to produce a total score ranging from 0 to 44 (reported in the Table). Higher scores reflect greater impairment.|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
172151|NCT00108628|Secondary|Pittsburgh Sleep Quality Index - Addendum|The PSQI-A is a measure of PTSD-related sleep and dream disturbances. Scores can range from 0 to 21, with higher scores reflecting greater sleep problems.|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
172152|NCT00108628|Primary|Pittsburgh Sleep Quality Index|Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.|Baseline and 1, 3, and 6 months post-treatment|||units on a scale||Standard Deviation|Mean
172153|NCT00108628|Primary|Weekly Nights With a Nightmare||Baseline and 1, 3, and 6 months post-treatment|||nights/week||Standard Deviation|Mean
172154|NCT00108628|Primary|Weekly Number of Nightmares||Baseline and 1, 3, and 6 months post-treatment|||weekly nightmares||Standard Deviation|Mean
172155|NCT00108550|Secondary|Roland and Morris Disability Index Scores Adjusted for Time|"This questionnaire measures disability in everyday function due to back pain. It is a 24-item checklist asking patients to endorse whether or not back pain limits activities they normally do (eg, I stay at home most of the time because of my back). Scores range from 0 to 24, with higher scores indicating greater disability in everyday function due to back pain. The single values reported below represent adjusted means of scores over all time points."|Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9|Randomized participants who received one dose of study drug||units on a scale||95% Confidence Interval|Mean
172156|NCT00108550|Primary|Transformed Descriptor Differential Scale-Pain Intensity Scores Adjusted for Time|"Self-report measure of current pain intensity of chronic back pain. Participants rate pain on a 20 point scale as being greater or less intense relative to 12 adjectival descriptor word anchors (eg, greater or less than faint, moderate, strong). Scores range from 0 to 20 with higher scores indicating higher pain intensity. Prior to analysis an order-preserving mean-matching variance-stabilizing transformation was applied to this measure placing it on a continuous 0-1.5 scale. The single values reported below represent adjusted means of transformed pain intensity over all time points."|Baseline to Week 12 with Interim Measurement at Weeks 1, 2, 3, 4, 5, 7 and 9|Analysis of all randomized participants receiving study drug||units on a scale||95% Confidence Interval|Mean
172157|NCT00108524|Secondary|Change From Baseline in Blood Sugar at 48 Weeks|Measured change in Fasting glucose, mg/dL, from baseline to 48 weeks.|Baseline and 48 weeks|||mg/dL||95% Confidence Interval|Mean
172158|NCT00108524|Secondary|Change From Baseline in Risk Factors for Heart Disease (e.g., Lipid Profiles) at 48 Weeks|Measured change in low-density lipoprotein cholesterol, or LDL-C, from baseline to 48 weeks.|baseline and 48 weeks|||mg/dL||95% Confidence Interval|Mean
172159|NCT00108524|Primary|Change From Baseline in Body Weight at 48 Weeks|Body weight was measured using the same calibrated scale (Tanita Corp, Arlington Heights, Illinois) at each visit at the same time of day, with the participant wearing light clothing and no shoes.|baseline and 48 weeks|||percentage of weight loss||95% Confidence Interval|Mean
172160|NCT00108485|Primary|Change in Proteinuria||Baseline, 1 year|Nine participants were enrolled into this study, however baseline data is only available for 2 participants (1 from the Extended Release Niacin arm and 1 from the Placebo arm). Data was only analyzed for 2 participants.||mg/dL|||Number
172161|NCT00108433|Secondary|Percentage of Participants With Eradication of Staphylococcus Aureus Nasal Colonization|Eradication was defined as the absence of the original baseline nasal Staphylococcus aureus isolated in nasal swab culture.|STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.||Percentage of participants|||Number
172162|NCT00108433|Secondary|Percentage of Pathogens Eradicated|Eradication included Documented or Presumed Eradication of the given pathogen. Percentage of pathogen eradicated was calculated as number of pathogens eradicated divided by number of pathogens eradicated or persisted multiplied by 100.|STFU visit for TOC (2 to 3 weeks after the last dose of study medication), LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.||Percentage of Pathogens|||Number
172163|NCT00108433|Secondary|Number of Participants With Complications During Therapy|Late metastatic sequelae associated with Gram positive bacterial infections: abdominal abscess, brain abscess, meningitis, septic arthritis, osteomyelitis, endocarditis, empyema, spinal epidural abscess, intracerebral epidural abscess, septic phlebitis and septic thrombophlebitis.|LTFU visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.||participants|||Number
172164|NCT00108433|Secondary|Number of Participants With Clinical Outcome Based on Sponsor's (Sp) and Investigator's (Ir) Assessment|Ir assessment Cure: clinical signs/symptoms of infection (SSx) resolved and no reoccurrence; Improvement: Moderate resolution of SSx, no additional antibiotic needed; Failure: persistence/progression of baseline SSx, new clinical findings; Indeterminate: circumstances precluding above classification. Sp assessment Failure: concomitant antibiotic after day 3 up to/including Ir assessment day at TOC/upper limit of TOC window (if no Ir assessment at TOC), no Ir assessment at end of treatment (EOT) and TOC; Indeterminate: Sp assessment cured/ improved at EOT, no Ir assessment at TOC/indeterminate.|EOT (within 72 hours after last dose of study medication), STFU visit for TOC (2 to 3 weeks after the last dose of study medication), Long term follow-up (LTFU) visit (6 to 8 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.||participants|||Number
172165|NCT00108433|Primary|Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit|Microbiological response assessed at participant level. Eradication = baseline isolate not present in repeat culture from the original infection site; Presumed Eradication = clinical response of cure based on Sponsor's (Sp) assessment, culture data not available for participants; Persistence = baseline isolate present in repeat culture from the original infection site; Presumed Persistence = culture data not available for participants with a clinical response of failure based on Sp assessment.|Short term follow-up (STFU) visit for TOC (2 to 3 weeks after the last dose of study medication)|Data was not analyzed because there were not enough participants to perform a meaningful efficacy analysis due to early termination of the study.||participants|||Number
172166|NCT00108355|Secondary|Development of Post-paracentesis Circulatory Dysfunction (PCD)|Defined as an increase in Plasma Renin Activity (PRA) by >50% from baseline to a level > 4 ng/mL/h at post-paracentesis day|6 days after paracentesis|Plasma Renin Activity (lab value to measure PCD) was not available for 6 patients leaving 11 patients in Albumin (control group) and 8 patients in Vasoconstrictor (Treatment group) for this outcome analysis.||participants|||Number
172167|NCT00108355|Primary|Time to Recurrence of Ascites.|Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)|Variable depending on the patient, average 10 days|||days||Inter-Quartile Range|Median
172168|NCT00108342|Primary|Quit Attempts, Use of NRTs, Preference Among NRTs|In addition to quit attempts, use of NRTs, and preference among NRTs, we also planned to assess learning and changes in motivation at all visits. Unfortunately, the study was terminated due to common comorbidities among the Veterans that precluded entry into the study. Due to the consequent small sample size, we did not analyze any data.|At testing, at follow-up|The study was terminated and the data were not analyzed due to the small sample size.|||||
172169|NCT00107783|Secondary|Change in 6 Minute Walk Test (6MWT)|Change from baseline of the 6MWT at 36 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.||ft||Standard Deviation|Mean
172170|NCT00107783|Secondary|Change in Timed Get up and go|Change from baseline of timed get up and go at 36 months. In timed get up and go, the patient is asked to stand up from a standard chair and walk a distance of 3 meters, turn around and walk back to the chair and sit down. The examiner measures the time it takes for the patient to perform this series of tasks.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.||seconds||Standard Deviation|Mean
172171|NCT00107783|Secondary|Change in Functional Reach Assessment|Change from baseline of functional reach assessment at 36 months. Functional reach assessment measures the difference between the length of a person's outstretched arm and their maximal reach forward, while maintaining balance.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.||cm||Standard Deviation|Mean
172172|NCT00107783|Secondary|Change in Schober's Test|Change from baseline of Schober's test at 36 months. Schober's test measures a patient's ability to flex his/her lower back. The examiner makes a mark at L5 (fifth lumbar vertebra) and places one finger 5 cm below and another finger 10 cm above this mark. The patient is asked to touch his/her toes. The examiner measures the increase in distance between the two fingers.|Measured at baseline and at 36 months|In the control group, two patients who dropped out for personal reasons were not included in this analysis, and in the treated group one patient who died was not included in this analysis.||cm||Standard Deviation|Mean
172173|NCT00107783|Primary|Change in Total ROM Worse Hip.|Change from baseline in the total (external + internal) hip range of motion (ROM) in the worse hip at 36 months.|Measured at baseline and at 36 months|Intention to treat.||degrees||Standard Deviation|Mean
172175|NCT00107653|Secondary|Number of Participants With Marked Abnormal Laboratory Parameters|The below table includes participants with marked abnormal lab parameters. Standard reference ranges include: Hematocrit: (fraction) 0.37 - 0.49, Hemoglobin 130 – 180 g/L, Platelets 150 – 350 10^9/L, White Blood Cell (WBC) 4.5 - 11.0 10^9/L, Lymphocytes 1.00 - 4.80 10^9/L, Neutrophils 1.80 - 7.70 10^9/L, Aspartate aminotransferase (AST) 0-40 U/L, ALT 0 – 55 U/L, Total bilirubin 0 – 17 μmol/L, Thyroxine T4 58 – 140 nmol/L, Thyroid Stimulating Hormone (TSH) 0.0 - 5.0 million units (mU)/L, Albumin 35.0 - 55.0 g/L, Chloride 100 – 108 mmol/L, Calcium 2.10 - 2.60 mmol/L, Phosphate 0.84 - 1.45 mmol/L, Uric acid 214 – 506 μmol/L.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment. 'n'=number of evaluable participants available at specified time point.||Participants|||Number
172176|NCT00107653|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An adverse event could therefore be any unfavorable or unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were reported as adverse events. A serious adverse event (SAE) was any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of hospitalization, or results in disability/incapacity, or congenital anomaly/birth defect.|Up to Week 72|The Safety Population included participants who received at least 1 dose of any study drug and had at least 1 post baseline safety assessment.||Participants|||Number
172177|NCT00107653|Secondary|Mean Change in 36-item Short Form Health Survey Total and Domain Scores From Baseline at Week 48 and 72|The 36-item Short Form Health Survey (SF-36) is a 36-item self-report questionnaire that includes 8 domain scales The 8 domains are incorporated into 2 components: mental and physical. The mental component (MC) includes social functioning, role limitations-emotional, mental health, and vitality. The physical component (PC) includes physical functioning, role limitations-physical, bodily pain, and general health perception. Raw domain scores are transformed to a 0 to 100 scale, [0=worst score (or quality of life) and 100=best score]. Two summary scale scores were computed based on weighted combinations of the 8 domain scores (Physical and the Mental Component) where no minimum or maximum score; higher score indicate better health status. The difference between study groups in change from baseline in SF-36 score at week 48 and 72 was analysed.|Baseline (Week 0), Week 48 and Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy. 'n'=number of evaluable participants available at specified time point.||Score on a scale||Standard Error|Mean
172178|NCT00107653|Secondary|Mean Change in Fatigue Severity Scale Score and Fatigue Severity Scale Score Item 10 Visual Analog Scale Score From Baseline at Week 48 and Week 72|The Fatigue Severity Scale (FSS) is a 10-item self-report questionnaire designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 weeks by marking on a visual analogue scale (VAS) labelled at one end with “no fatigue” (‘0’ being the best) and at the other end with “greater fatigue” (‘100’ being the worst). Longer distance on the scale from “no fatigue” indicated “greater fatigue”. FSS values are presented based on questionnaire and visual analog scale. FSS values at week 48 and 72 are presented based on questionnaire and visual analog scale.|Baseline (Week 0), Week 48 and Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). 'n'=number of evaluable participants available at specified time point.||Score on a scale||Standard Error|Mean
172179|NCT00107653|Secondary|Percentage of Participants With Non-zero Nonalcoholic Steatohepatitis Score|The Nonalcoholic Steatohepatitis (NASH) included an assessment of sinusoidal fibrosis, Mallory bodies, and hepatocyte ballooning (HB). Grading categories for the NASH scales were as: Sinusoidal fibrosis: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules, without diffuse interstitial sinusoidal collagen deposition; 3 = Involvement of most or all lobules;, with diffuse interstitial fibrosis involving some or most of the lobules Mallory bodies: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules; and Hepatocyte ballooning: 0 = absent; 1 = involvement of some lobules; 2 = involvement of most lobules; 3= involvement of most or all lobules.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
172180|NCT00107653|Secondary|Percentage of Participants With Improved, Stable and Worsened Fat Score From Baseline to Week 72|Fat scores are categorised as Improved: > 1 category decrease in fat scale; stable: no change in fat scale; worsened: >= 1 category increase in fat scale.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
172181|NCT00107653|Secondary|Mean Change From Baseline in Fat Score at Week 72|Grading categories for the fat scale were as follows: 1 = <5% hepatocytes; 2 = 6 – 33% hepatocytes; 3 = 34 – 66% hepatocytes; 4 = 67 - 100% hepatocytes.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Score on a scale||Standard Error|Mean
172182|NCT00107653|Secondary|Percentage of Participants With Improved, Stable, and Worsened METAVIR Fibrosis Score|METAVIR fibrosis score is categorized as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: >= 1 category increase in activity score.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
172635|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||kilograms||Standard Error|Least Squares Mean
172183|NCT00107653|Secondary|Percentage of Participants With Improved, Stable, and Worsened METAVIR Activity Score|METAVIR activity scale included activity defines as, Improved: >= 1 category decrease in activity score; stable: no change in activity score; worsened: > = 1 category increase in activity score.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
172184|NCT00107653|Secondary|Mean Change From Baseline in Activity and Fibrosis Scores Based on METAVIR Activity at Week 72|METAVIR activity scores are categorised as histological activity (A) 0 = none; A1 = mild; A2 = moderate; A3 = severe where ‘0’ being ‘No activity’ and ‘3’ being ‘the sever activity’. Changes in liver inflammation defined as Improved: Participants whose METAVIR activity score at up to Month-72 decreases by 1 or more units compared to baseline; stable: Participants whose METAVIR activity score at up to Month-72 is the same as the baseline score; worsened: Participants whose METAVIR activity score at up to Month-72 increases by 1 or more units compared to baseline. METAVIR fibrosis scores are categorised as fibrosis (F) 0 = no fibrosis; F1 = without septa; F 2 = with septa; F3 = many septa; F4 = cirrhosis where; ‘0’ being the best and ‘4’ being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in activity and fibrosis scores based on METAVIR at week 72 was analysed.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Score on a scale||Standard Error|Mean
172185|NCT00107653|Secondary|Percentage of Participants With Improved, Stable and Worsened ISHAK Fibrosis Score|Overall ISHAK Fibrosis Score is defined as Improved: >= 1 category decrease in fibrosis scale; Stable: no change in fibrosis scale; Worsened: >1 category increase in fibrosis scale.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
172186|NCT00107653|Secondary|Mean Change From Baseline in Fibrosis Score Based on ISHAK at Week 72|ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) score at week 72. Baseline prognostic factors in the original model include ethnicity, sex, age, baseline ALT quotient, baseline HCV-RNA level, and ISHAK fibrosis and activity scores at baseline. ISHAK modified HAI fibrosis scale by fibrosis grading category as F0= no fibrosis; F1= some portal areas; F2= most portal areas; F3= bridging fibrosis; F4= bridging and portal to central; F5 = marked bridging; F6 = Cirrhosis; where ‘0’ being the best and ‘6’ being the worst. Decrease in score from baseline indicates improvement. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was analysed.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy. 'n'=number of evaluable participants available at specified time point.||Score on a scale||Standard Error|Mean
172187|NCT00107653|Secondary|Mean Change From Baseline in ISHAK HAI Activity (Necroinflammatory) at Week 72|ISHAK modified HAI activity (necroinflammatory) score is a total score of P/B necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each Participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5= zone 3 multiple; 6= panacinar necrosis and Focal necrosis as 0: absent; 1: <= 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal. The difference between study groups in change from baseline in ISHAK modified HAI activity score at week 72 was tested using an analysis of covariance (ANCOVA) model with ethnicity and baseline ISHAK HAI score as the fixed effects.|From Baseline (Week 0) to Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Score on a scale||Standard Error|Mean
172188|NCT00107653|Secondary|Percentage of Participants With ISHAK Histological Activity Index Response|ISHAK Histological Activity Index (HAI) activity response is defined as a decrease from baseline of at least 2 points (≥2 points drop from baseline) in the ISHAK modified HAI (necroinflammatory) score at week 72. ISHAK modified HAI activity (necroinflammatory) score is a total score of periportal ± bridging (P/B) necrosis + confluent necrosis + focal necrosis + portal inflammation (maximum score for each participant = 18). Where P/B necrosis grading as 0 = absent; 1 = mild; 2 = mild/moderate; 3 = moderate; 4 = severe; Confluent necrosis grading as 0 = absent; 1 = focal; 2 = zone 3 some areas; 3 = zone 3 most areas; 4 = zone 3 occasional portal; 5 = zone 3 multiple; 6 = panacinar necrosis and Focal necrosis grading as 0: absent; 1: < = 1 focus; 2: 2 to 4 foci; 3: 5 to 10 foci; 4: > 10 foci; Portal Inflammation grading: 0 = none; 1 = mild; 2 = moderate; 3 = moderate/marked; 4 = marked/all portal.|At Week 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). Analysis was performed for ITT participants with paired biopsy.||Percentage of participants|||Number
172189|NCT00107653|Secondary|Percentage of Participants With Biochemical Response|Biochemical response was defined as normal serum alanine transaminase (ALT) measurement. For ALT measurement the normal range is 5-37 IU/L.|At Weeks 4, 12, 24, 48, 60 and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).||Percentage of participants|||Number
172190|NCT00107653|Secondary|Change From Baseline in HCV-RNA Log10 Titers Over the Period Of Time|The table below shows HCV-RNA log10 titers change from baseline values by study week and by study group. Analysis was performed for participants with a baseline and at least 1 post-baseline HCV-RNA assessment. HCV-RNA quantitation was performed using Roche High Pure System/COBAS® TaqMan® HCV Monitor Test. HCV-RNA measurement lower limit of detection was 28 IU/mL.|From Baseline (Week 0) to Weeks 4, 12, 24, 48, 60 and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus). 'n'=number of evaluable participants available at specified time point.||Log10 IU/mL||Standard Error|Least Squares Mean
172191|NCT00107653|Secondary|Percentage of Participants With Early Virologic Response at Week 12|Percentage of participants with an early virologic response defined as an HCV-RNA >=2 log10 drop from baseline or undetectable HCV-RNA measurement at Week 12 (lower limit of detection 28 IU/mL).|At Week 12|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).||Percentage of participants|||Number
172192|NCT00107653|Secondary|Percentage of Participants With Early Virologic Response at Week 4|Percentage of participants with an early virologic response defined as an HCVRNA >=1 log10 drop from baseline or undetectable HCV-RNA measurement at Week 4 (lower limit of detection 28 IU/mL).|At Week 4|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).||Percentage of participants|||Number
172193|NCT00107653|Secondary|Percentage of Participants Achieving Virologic Response|Percentage of participants achieving a virologic response defined as an undetectable HCV-RNA measurement (HCV-RNA <28 IU/mL by Roche High Pure System/COBAS TaqMan HCV Test)|At Weeks 4, 12, 24, 48, 60, and 72|ITT Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).||Percentage of participants|||Number
172194|NCT00107653|Primary|Percentage of Participants With Sustained Virologic Response at Week 72|Sustained Virologic Response (SVR) is defined as percentage of participants with an undetectable hepatitis C virus-RNA (HCV-RNA) measurement (<28 International Unit (IU)/millilitre (mL)) assessed 24 weeks post-treatment (week 72) which was assessed by Roche High Pure System/COBAS TaqMan HCV Test.|At Week 72|Intent-to-Treat (ITT) Population included all participants who were enrolled and took at least 1 dose of study drug (Pegasys or Copegus).||Percentage of participants|||Number
172195|NCT00107614|Primary|Response Rates to a Brief Remission Induction Treatment With One or Two Courses of Melphalan-based High-dose Treatment (HDT)|To evaluate the complete and partial response rates, defined in a strict manner, to a brief remission induction treatment with one or two courses of melphalan-based high-dose treatment (HDT) in symptomatic patients with Waldenström’s Macroglobulinemia (WM), either untreated or previously treated.|3 years|||participant|||Number
172196|NCT00107575|Primary|Smoking Abstinence at 2 Weeks|7 days of smoking abstinence confirmed biochemically at 2 weeks|2 weeks|||Participants|||Number
172197|NCT00107575|Primary|Smoking Abstinence at 8 Weeks|7 days of smoking abstinence confirmed biochemically at 8 weeks|8 weeks|||Participants|||Number
172198|NCT00107575|Primary|Smoking Abstinence at 16 Weeks|7 days of smoking abstinence confirmed biochemically at 16 weeks|16 weeks|||Participants|||Number
172199|NCT00107575|Secondary|Alcohol Drinks Consumed Per Week Over a 2-week Period|Average number of standard alcoholic drinks consumed per week over each 2-week period across the 26 weeks of follow-up as assessed by the Timeline Followback Interview. Standard alcoholic drink is defined as 12 oz of beer, 5 oz of wine, or 1.5 ounces of liquor.|At 2, 8, 16, and 26-week follow-ups|The number of participants analyzed reflects the number of participants who provided at least some valid data on the Timeline Followback Interview||drinks||Standard Deviation|Mean
172200|NCT00107575|Primary|Smoking Abstinence at 26 Weeks|7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt|26 weeks|For analyses of smoking outcomes, missing data were considered smoking. However, at 26 weeks, 2 participants in ST-BI had died and therefore their data was left as missing for this period.||participants|||Number
172201|NCT00108303|Primary|Log of the ODDS of Linkage|Log of the ODDS ratio of Linkage divided by the ODDS of no linkage from a maximum likelihood analysis conducted using the statistical program LINKAGE|1 day|Probands with schizophrenia, their relatives, and controls. The log of the odds ratio summarizes data from the entire study population.||units on a log scale|||Number
172202|NCT00108303|Primary|Heritability Coefficient|h squared which ranges from 0 to 1. This number is similar to the more standard Pearson's correlation coefficient, except that the variable, in this case P50 sensory gating, is correlated across the statuses: schizophrenia proband (has the illness), schizophrenia relative (not ill but relative of someone who is), or control (not ill and has no known ill relative, P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds.|5 years|Schizophrenia probands and relatives and controls.||coefficient|Participants||Number
172203|NCT00108303|Primary|Genetic Linkage|Log of the Odds for Linkage, a standard genetic analysis metric. The number shown as a result is from a polymorphism in the promoter of the gene for the alpha7 nicotinic receptor on chromosome. Its presence in the individuals in this study, considering all three groups in one analysis, is compared to what of P50 sensory gating. P50 is a Positive wave in scalp-recorded auditory evoked potential that occurs 50 msec after the sound stimulus. P50 sensory gating is the decrement in this wave to the second of repeated sounds. The log of the odds is the common logarithm of the ratio of the odds that the gene polymorphism and P50 sensory gating are associated versus the odds that they are both distributed in the individuals at random. It is similar to the more common chi squared.|ten years|People with schizophrenia and their relatives in families and controls as members of single families were used to establish the log of the odds ratio.||log (odds ratio)|||Number
172204|NCT00108277|Primary|Episodic Anxiety Scale|Episodic Anxiety Scale (EAS) is a modification of the Panic Disorder Severity Scale (Shear et al., 1997) that includes 2 additional questions regarding acute anxiety episodes that may not meet full criteria for a panic attack. The EAS consists of 9 questions, each ranging from 0 (none) to 4 (worst possible). The EAS total score is the sum of all 9 items, such that the minimum total score = 0 (no anxiety symptoms) and maximum total score = 36 (worst possible anxiety symptoms).|1 month|||units on a scale||Standard Deviation|Mean
172205|NCT00108160|Other Pre-specified|S. Aureus Re-infections (New or Recurrent)|The anatomic site of each S. infection at enrollment and S. aureus re-infection that occurred during the study was compared. S. aureus isolated from a different site of infection than at baseline was considered to represent a new infection. Isolation of S. aureus from the same site as the baseline infection was considered to represent a recurrent infection.|18 months|||participants|||Number
172206|NCT00108160|Secondary|Acquisition of New S. Aureus Strains|In the Mupirocin Ointment (Treatment) and Polyethylene Glycol (Placebo) Arms, S. aureus isolates (MSSA or MRSA) that caused infection prior to enrollment in the study were compared with S. aureus infecting isolates (MSSA or MRSA) that occurred during the study (re-infections). Infecting isolates that were found to be MRSA at enrollment and MRSA during the study were considered to be the same strain; this same strain definition was also applied to MSSA isolates. Infecting isolates that changed from MRSA at enrollment to MSSA during the study (or vice versa) were considered to be different strains.|18 months|Participants with S. aureus re-infection who acquired a new strain during the 18 month study period.||participants|||Number
173549|NCT00095498|Secondary|Change From Baseline in Platelets at Month 12|Laboratory hematology platelets|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
172207|NCT00108160|Primary|Re-infection With S. Aureus|During the study, patients with prior well-documented infections with Staphylococcus aureus who developed new signs and symptoms of infection, met standardized clinical criteria for infection, and had S. aureus isolated on culture were considered to have re-infection with S. aureus. The number of S. aureus re-infections were compared in the mupirocin ointment (Treatment Arm) versus polyethylene glycol ointment (Placebo Arm) for all participants enrolled in the study and in participants who completed each study time point (visit)|18 months|Re-infections with S. aureus, new or recurrent, were noted for all patients enrolled in the study and for patients who completed each study visit.||participants with S. aureus re-infection|||Number
172208|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed Albumin Creatinine Ratio (ACR) at Month 12|Urinary ACR (micrograms per milligram) was determined at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (exponent (mean change on log scale) - 1. [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)||percentage of change||95% Confidence Interval|Geometric Mean
172209|NCT00108082|Secondary|Percentage Change From Baseline in Log Transformed Lipid Parameters at Month 12|Plasma lipid concentrations (milligrams per deciliter) were measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent(mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)||percentage of change||95% Confidence Interval|Geometric Mean
172210|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed C-Reactive Protein (CRP) at Month 12|CRP concentration (milligrams per deciliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and calculated as 100 x (exponent (mean change on log scale) - 1). [Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.]|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used)|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)||percentage of change||95% Confidence Interval|Geometric Mean
172211|NCT00108082|Secondary|Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed B-type Natriuretic Peptide (BNP) at Month 12|BNP concentration (picagram per milliter) was measured at Baseline and after 12 months of treatment/Month 12. Percentage change from Baseline was based on log transformed data and was calculated as 100 x (exponent (mean change on log scale) -1) [Change is the Month 12 value (or value after 12 months of treatment) minus the Baseline value].|Baseline and Month 12 (If Month 12 data were not available, the LOCF was used|All randomized participants who had a valid measurements at Baseline and Month 12 (LOCF)||percentage of change||95% Confidence Interval|Geometric Mean
172212|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12|Systolic and Diastolic BP were measured at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||mmHg (millimeters of mercury)||Standard Error|Mean
172213|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12|LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||milliliters (mL)||Standard Error|Mean
172214|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12|LV End Systolic and Diastolic Volumes and Ejection Fraction were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. The ejection fraction is the fraction of the blood volume available at the end of diastole that is pumped out of the ventricules during systole.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||milliliters (mL)||Standard Error|Mean
172215|NCT00108082|Secondary|Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12|LV filling parameters, LV E-Volume and LV A-Volume, were measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. These filling parameters represent the volumes of blood filling the ventricle during the passive filling phase (E-volume) and the active filling phase caused by atrial contraction (A-volume).|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||milliliters (mL)||Standard Error|Mean
172216|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12|LV Mass was measured by echocardiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||grams||Standard Error|Mean
172217|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12|LVMIH was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was available)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||g/m raised to 2.7 (g/(m^2.7))||Standard Error|Mean
172218|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12|LVMI was measured by echogradiography at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid echocardiogram at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||grams per meters squared (g/m^2)||Standard Error|Mean
172219|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12|LV Mass was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||grams (g)||Standard Error|Mean
172220|NCT00108082|Secondary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12|LVMIH was measured by MRI at Baseline and after 12 months of treatment/Month 12. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value. LV mass depends on body size. One method of determining whether an individual has LV hypertrophy relates LV mass to height raised to a power of 2.7.|Baseline and Month 12 (If Month 12 data were not available, the LOCF analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||g/m raised to 2.7 (g/(m^2.7))||Standard Error|Mean
172221|NCT00108082|Primary|Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Magnetic Resonance Imaging (MRI) at Month 12|LVMI was measured by MRI at Baseline and after 12 months of treatment/Month 12. A reduction in left ventricular mass, calculated as LVMI, of 5 g/m^2 was assumed to be clinically meaningful. Change in Baseline was calculated as Month 12 value (or value after 12 months of treatment) minus the Baseline value.|Baseline and Month 12 (If Month 12 data were not available, the Last Observation Carried Forward [LOCF] analysis, which includes data collected on or after Month 9 of treatment to Month 12 of treatment, was used)|All randomized participants who had a valid MRI at Baseline and Month 12 (LOCF on or after Month 9 to Month 12)||grams per meters squared (g/m^2)||Standard Error|Mean
172222|NCT00108069|Secondary|Adverse Event Grades|The combined serious and non-serious adverse event Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs for the GBM (Glioblastoma multiforme) and AG (Anaplastic glioma) cohorts.|7.5 years|Neither cohort completed planned accrual and are small in number separately. Additionally, the underlying histological grade would not affect toxicity. Therefore, these cohorts may be combined. The Table describes count of patients whose highest grade adverse event for any CTC (common terminology criteria) term was related to study drugs.||participants|||Number
172223|NCT00108069|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|7.5 years|||Participants|||Number
172224|NCT00108069|Primary|Response, Defined as Stable Disease or Objective (Partial or Complete) Response.|Complete response (CR) is complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. All measurable, evaluable and non-evaluable lesions and site must be assessed using the same techniques as baseline. Patients who respond must be on the same or decreasing doses of dexamethasone. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using same techniques as baseline. Responders must be on the same decreasing doses of dexamethasone. Stable disease (SD) does not qualify for CR, PR, or progression (e.g., a 25% increase in the sum of products of all measurable lesions). The designation of stable/no response requires a minimum of 6 weeks duration. All measurable and evaluable sites must be assessed using the same techniques as baseline.|Patients were followed for an average of six weeks for assessment of response|Two patients were not able to complete follow-up neuroimaging to assess response due to clinical progression of disease.||Participants|||Number
172225|NCT00107991|Secondary|Dermatology Life Quality Index Score (DLQI)|"The DLQI is a dermatology-specific health-related quality of life measure. The effect on a patient's life is as follows: 0-1=none; 2-5=small; 6-10=moderate; 11-20=very large; and 21-30=extremely large. Responders were defined as those who achieved a 50% improvement in the DLQI score.~Response rates were calculated as the percentage of participants achieving a response."|12 weeks|||Response Rate - % of participants||95% Confidence Interval|Number
172226|NCT00107991|Secondary|Patient's Pain Score|Patient's were asked to self-report their pain on a 100-mm visual analog scale (with 0 corresponding to no pain and 100 mm corresponding to severe pain). Responders were defined as those achieving at least a 50% reduction in pain score from baseline to week 12. Reponse rate was calculated as the percentage of patients classified as responders.|12 weeks|||Response Rate - % of participants||95% Confidence Interval|Number
172227|NCT00107991|Secondary|Patient Global Assessment|"The Patient Global Assessment asked patients to rate the extent of hidradenitis activity compared to when the patient started treatment with etanercept (day 0 of study). The scale included a selection of:~Much worse than before treatment Moderately worse (about 50% more disease activity) A little worse Same A little improved Moderately improved (about 50% reduction in disease activity) Much better than before treatment (no active disease or almost no active disease)"|12 weeks|||number of participants|||Number
172228|NCT00107991|Primary|Physician's Global Assessment Score - Response Rate (Percentage)|"Efficacy was measured using the Physician Global Assessment (PGA). Responders were classified as those achieving at least a 50% reduction on the Physician Global Assessment score at week 12 compared with baseline. A response rate was calculated as the percentage of patients that were classified as responders at 12-weeks.~PGA was scored at baseline and at 12 weeks on a 100-mm visual analog scale, with 0 indicating no disease and 100-mm indicating severe disease."|12 weeks|||Response Rate - % of participants||95% Confidence Interval|Number
172229|NCT00107991|Secondary|Number of Lesions (Response Rate - Percentage)|A physician assessed number of lesions as baseline and week 12. Responders were defined as those achieving at least a 50% reduction in number of lesions. A response rate was calculated as percentage of patients classified as responders.|12 weeks|||Response Rate - % of participants||95% Confidence Interval|Number
172230|NCT00107978|Primary|Clinical Response|The Clinical Response for each patient was determined by the investigator by assessing the patient's clinical signs & symptoms compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.|7 to 14 days after the last antibiotic dose|Data for the all-treated population (AT) are presented. The AT and clinically evaluable (CE) populations were considered co-primary.||patients|||Number
172231|NCT00107952|Primary|Clinical Response|"Clinical Response: Categorical (Cured, Failed or Indeterminate)~Failure is at least one of the following: Persistence or progression of signs and symptoms of pneumonia that still require antibiotic therapy; Termination of study med due to “lack of efficacy”; Death on or after Day 3 attributable to primary infection~Cure: Signs and symptoms of pneumonia improved to the point that no further antibiotics for pneumonia were required, and baseline radiographic findings improved or did not progress.~Indeterminate: Inability to determine outcome"|7 - 14 days following end of antibiotic treatment|||participants|||Number
172232|NCT00107536|Secondary|Expression Profile and Mutations of Genes Critical for EGFR and ERBB2 Signaling Pathways||Up to 3 years|||patients with mutations|||Number
172233|NCT00107536|Secondary|Target-EGFR/EGFR-P Protein Expression|EGFR (exons 18-21)|Up to 3 years|||patients with somatic mutations|||Number
172234|NCT00107536|Secondary|Overall Survival||up to 12.6 months|||months||95% Confidence Interval|Median
172235|NCT00107536|Secondary|Median Overall Survival||Up to 3 years|||months||95% Confidence Interval|Median
172236|NCT00107536|Secondary|Toxicity Profile Assessed Using NCI CTCAE Version 3.0|Percentage of patients with Adverse events accordng to NCI CTCAE version 3.0|Up to 3 years|All 26 patients were evaluable for toxicity analysis.||percentage of patients|||Number
172237|NCT00107536|Secondary|Progression-free Survival||up to 6 months|||months||95% Confidence Interval|Median
172238|NCT00107536|Primary|Proportion of Patients Demonstrating Objective Response (PR+CR) as Defined by RECIST|PR (Partial Response) definded as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. CR (Complete Response) is defined as the disappearance of all target lesions.|Up to 3 years|Only 25 patients were evaluable for response (1 patient passed away before staging).||patients|||Number
172239|NCT00107380|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|6 months (assessed at the end of each cycle of chemotherapy for 8 cycles (1 cycle= 21 days), at restaging, and at the end of each radiolabeled antibody treatment)|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
172240|NCT00107380|Primary|Response Rate (Complete, Complete Unconfirmed, and Partial)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|6 months|All eligible patients who started treatment were included in the analysis||participants|||Number
172241|NCT00107380|Primary|Progression-free Survival (PFS) at 2 Years|Clinical responses were evaluated according to International Workshop NHL criteria (Cheson et al, 1999). Progression disease was defined as if a (CR, CRU) was not achieved at a previous assessment, a 50% increase in the SPD of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Appearance of a new lesion/site. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Death due to disease without prior documentation of progression. PFS is measured from date of registration to date of first observation of progressive disease, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0-2 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
172242|NCT00107315|Secondary|Toxicity|"Number of participants with an adverse event.~Please refer to the adverse event reporting for more detail."|1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
172243|NCT00107315|Secondary|Median Survival||1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
172244|NCT00107315|Secondary|Response Rate|Overall Response (OR) = CR + PR.|1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
172245|NCT00107315|Primary|Time to Progression||1 year|Due to the study’s early termination and inadequate number of patients, no patients were analyzed.|||||
172343|NCT00106639|Secondary|Fasting Serum Glucose Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||mg/dL||Standard Deviation|Mean
172246|NCT00107276|Secondary|Toxicity|Number of patients for whom Grade 3 or higher toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Patients assessed after each 21-day cycle for 8 cycles (24 weeks of treatment)|Eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)||Participants|||Number
172247|NCT00107276|Secondary|Progression-free Survival and Overall Survival|"Progression-Free Survival: From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact.~Overall Survival: From date of registration to date of death due to any cause. Patients last known to be alive are censored at last date of contact.~Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression."|two years|All eligible patients||months||95% Confidence Interval|Median
172248|NCT00107276|Primary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Patients assessed at least every six weeks while on protocol treatment|Eligible patients with RECIST measurable disease||participants|||Number
172249|NCT00107198|Secondary|Grade 3 or 4 Toxicity||Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days.|Eligible patients beginning AV-PC.||Participants|||Number
172250|NCT00107198|Secondary|Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients|To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy.|At 5 years|Of 188 patients enrolled, five ineligible patients were excluded. 136 patients received upfront AV-PC with or without RT per protocol. Of these 135 achieved CR with AV-PC and avoided RT. The median follow up among the 121 censored patients is 62.2 months (range 3.4-104.5).||Probability participants||95% Confidence Interval|Number
172251|NCT00107198|Secondary|Cure by Surgery Alone in Stage I Resected Patients|To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone.|At 2 years|Of 188 patients enrolled, five ineligible patients were excluded. 52 patients with Stage IA, single node LPHL were enrolled with a confirmed total resection (TR). The median follow up among the 39 censored patients is 56.3 months (range 3.9-107.4).||Probability participants||95% Confidence Interval|Number
172252|NCT00107198|Secondary|Event-free Survival|Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment.|At 5 years|Of 188 patients enrolled, five ineligible patients were excluded from this analysis. 183 patients are included. The median follow-up time for the 155 censored patients is 61.2 months (range 0.03-107.4).||Probability participants||95% Confidence Interval|Number
172253|NCT00107198|Primary|Failure-free Survival (FFS)|The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause.|At 5 years|Of 188 patients enrolled, five ineligible patients and five patients who did not receive the upfront chemotherapy +/- RT per protocol were excluded from this analysis. 178 patients are included. The median follow-up for the 164 censored patients is 61.2 (range 3.5-107.4) months.||Probability participants||95% Confidence Interval|Number
172254|NCT00107172|Secondary|DLCO% Measured at Baseline and Month 3|"Pulmonary function tests included percentage predicted carbon~> monoxide diffusing capacity of the lung (DLCO%) at baseline and month 3 were compared between arms."|3 months|All participants with complete pulmonary function test data at baseline and month 3.||Percentage of Predicted||Full Range|Median
172255|NCT00107172|Secondary|FEV1% Measured at Baseline and Month 3|Pulmonary function tests included percentage predicted forced expiratory volume in 1 second (FEV1%) at baseline and month 3 were compared between arms|3 months|All participants with complete pulmonary function test data at baseline and month 3.||Percentage of Predicted||Full Range|Median
172256|NCT00107172|Secondary|Dyspnea as Measured Using SOBQ at Baseline, Months 3, Months 12 and 24|Dyspnea was evaluated using the University of California, San Diego Shortness of Breath Questionnaire (SOBQ). It consists of 24-item on a scale of 0 to 5 with 0=not at all and 5=maximal or unable to do because of breathlessness. The total scores was calculated by summation of the 24 items scores and transformed into 0-100, with 0= poor quality of life , and 100= excellent quality of life..|24 months|Participants who met the eligibility criteria and had SOBQ data at baseline, month 3, 12 or 24.||units on a scale||Full Range|Median
172257|NCT00107172|Secondary|Global QOL as Measured Using SF36 at Baseline, Month 3, 12 and 24|Short-form health survey (SF36) consist of 36 items, where scores can be reported as 8 domains of functional health and well-being, or transformed into a physical component summary (PCS) score and a mental component summary (MCS) score. Standardized scores of SF36 PCS and MCS scores were calculated using the mean, SD, and scoring coefficients from the US general population. The standardized scores were then adjusted for age and gender using the mean and SD of the US general population according to age and gender grouping, and employing a linear transformation. Scores <50 indicate below-average health status.|24 months|Participants who met the eligibility criteria and had SF 36 data at baseline, month 3, 12 or 24.||units on a scale||Full Range|Median
172258|NCT00107172|Secondary|Number of Participants Reported Grade 3+ Respiratory Adverse Events Within 90 Days After Sublobar Resection|The respiratory AE included adult respiratory distress syndrome, aspiration, bronchospasm, bronchostenosis, dyspnea, hypoxia, pleural effusion, pneumonitis, chest tube drainage or leak, prolonged intubation, pulmonary-other, and pneumonia as defined by the CTCAE version 3.0.|90 days|All Intent-to-Treat (ITT) participants.||participants|||Number
172259|NCT00107172|Secondary|Number of Participants Reported Grade 3+ Adverse Events Within 90 Days After Sublobar Resection|Adverse Events were assessed via the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.|90 days|All Intent-to-Treat (ITT) participants.||participants|||Number
172260|NCT00107172|Secondary|Mortality Rates at 30- and 90-day After Sublobar Resection||90 days|All Intent-to-Treat (ITT) participants||percentage of participants|||Number
172261|NCT00107172|Secondary|Number of Participants Reported Distant Recurrence at 3 Years|Distant recurrence was defined as the recurrence within contralateral lobe, contralateral mediastinal (N3) nodes or distant > metastatic disease (other organs).|3 years|All intent-to-treat participants.||participants|||Number
172262|NCT00107172|Secondary|Number of Participants Reported Regional Recurrence at 3 Years|Regional recurrence was defined as the recurrence within another lobe or pleura on the same side as the resection, or the ipsilateral mediastinal (N2) nodes.|3 years|All intent-to-treat participants.||participants|||Number
172263|NCT00107172|Secondary|Number of Participants Reported Local Recurrence at 3 Years|Local recurrence was defined as the recurrence within the same lobe or hilum (N1 nodes), or at the staple line after treatment effects such as scarring have subsided.|3 years|All intent-to-treat participants.||participants|||Number
172264|NCT00107172|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death due to any cause.|Up to 5 years|All intent-to-treat (ITT) participants||years||95% Confidence Interval|Median
172265|NCT00107172|Primary|Time to Local Recurrence|Local recurrence included the recurrence within the same lobe or hilum (N1 nodes), or progression at the staple line after treatment effects such as scarring have subsided. Time to local recurrence was censored 1) at the time of a distant recurrence, 2) at the last follow-up time when a patient died within 3 years of randomization without a local recurrence or 3) at 3 years follow-up if the patient remains alive 3 years post-randomization without a local recurrence.|Up to 3 years|All intent-to-treat (ITT) participants.||years||95% Confidence Interval|Median
172266|NCT00107120|Other Pre-specified|Children's Global Assessment Scale|Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest).|At baseline and end of week 8|The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.||Change in score||Standard Error|Mean
172267|NCT00107120|Secondary|Clinical Global Impressions - Improvement|Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse).|CGI-I score at the end of Week 8|The Intent-To-Treat Population was used. The Last Observation Carried Forward (LOCF) technique was used to impute missing data.||Score on scale||Standard Error|Mean
172268|NCT00107120|Primary|Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score|Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.|Baseline to end of week 8|Efficacy analyses used Intent-To-Treat Population, which consisted of all patients who received at least 1 dose of double-blind study drug & who had at least 1 post-baseline assessment of the CDRS-R. LOCF technique was used to impute missing data. 1 escitalopram pt. did not have a post-baseline CDRS-R total score.||Change in total score at endpoint||Standard Error|Mean
172269|NCT00107042|Secondary|Assessment of Youth Understanding of Vaccine Trial and Informed Consent|Assessment of understanding was measured by a questionnaire containing six questions. The summary score is the sum of correct answers from six questions.|Screening|||Number of correct answers||Standard Deviation|Mean
172270|NCT00107042|Secondary|As Treated Analysis – Adequate Antibody Response to Hep B Surface Antigen|The subject was considered seroresponsive to Hepatitis B Surface Antigen if the serum antibody level was greater than or equal to 10 mIU/mL. Those who received only a single vaccination, whose second vaccination was outside of the specified time window, or other cases of protocol violations were excluded from the analysis.|Week 28|Subjects who completed both vaccinations according to the protocol were included in the analysis (as treated analysis). Those who only had 1 vaccination,whose 2nd vaccination was outside the specified time window, or other cases of protocol violations, were excluded from the analysis.||percentage of participants|||Number
172271|NCT00107042|Secondary|Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination)|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at two time points: 1 and 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.|Week 28 and Week 76|Subjects in the Twinrix arm who had week 28 &/or wk 76 HepA serology results were included. For overall response analysis, if a subject was reactive at either wk 28 or wk 76, then the overall response for subject was considered “Positive”. If subject was non-reactive at both wk 28and wk 76, then the overall response for subject was “Negative”.||percentage of participants|||Number
172272|NCT00107042|Secondary|Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 12 months after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response.|Week 76|Subjects in the Twinrix arm who had a Week 76 hepatitis A serology results were included in this analysis.||percentage of participants|||Number
172273|NCT00107042|Secondary|Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination|Hepatitis A antibody response in those subjects in the combined vaccine arm (Twinrix) at 1 month after the 2nd vaccination. Immunogenicity to Hepatitis is given as a positive or negative response. If the Hepatitis A serology was reactive, then the participant was considered to have a positive response; if the Hepatitis A serology was non-reactive, then the participant was considered to have a negative response.|Week 28|The data for this analysis included those in the Twinrix arm who had week 28 hepatitis A serology results.||percentage of participants|||Number
172274|NCT00107042|Secondary|Immunogenicity to Hep B 18 Months After First Immunization|Persistence of protective antibody response was measured by presence or absence of 10 mIU/ml HepB surface antibody and geometric mean titer of the same antibody at Week 76|Week 76|"Participants who had a week 76 Hepatitis B antibody titer were included in this analysis.~One subject had an a'body titer at EOS visit but did not have a'body data at week 76. Since the EOS was close to week 76, the titer from EOS was recoded as the week 76 titer."||Participants|||Number
172275|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever used drugs not prescribed was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172276|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked marijuana was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172277|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever drank alcohol was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172278|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime female sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172279|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime male sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172280|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Total number of lifetime sex partners was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172281|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Age of participants’ first unforced sexual encounter was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172344|NCT00106639|Secondary|Number of Participants With New Onset Diabetes Mellitus (NODM)||Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172282|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Sexual identity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172283|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Whether participants ever smoked cigarettes was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172284|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. BMI at baseline was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172285|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Male participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of Wk 28 titer.||Participants|||Number
172286|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Tanner stage by gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Females who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer isn't sufficiently predictive of the Wk 28 titer.||Participants|||Number
172287|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Race was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the wk 28 titer.||Participants|||Number
172288|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Hispanic ethnicity was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172289|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER|Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum a'body level is < 10 mIU/mL. Gender was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
177805|NCT00006178|Primary|Serum Creatinine Concentration|measures at 12 months after intervention|12 months after intervention|||umol/L||Standard Deviation|Mean
172290|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE|Qualitative Vaccine Response to Hepatitis B (Hep B)Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Age was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172291|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT|Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a “Responder” if serum antibody level is >= 10 mIU/mL and a “Non- Responder” if a serum a'body level is < 10 mIU/mL. Site effect was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172292|NCT00107042|Secondary|Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.|Qualitative Vaccine Response to Hepatitis B Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Study arm was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.|Week 28|Participants who had a Wk 28 Hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.||Participants|||Number
172293|NCT00107042|Secondary|Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.|The Log10 titer at Week 28 was used as the quantitative continuous vaccine response.|Week 28|The data for this analysis included those who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (as treated population).||Participant|||Number
172294|NCT00107042|Primary|Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)|Frequency Distribution of SAE by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as “Any” vs. “None”. The number of participants with at least one SAE is reported.|Week 12, Week 24, Week 28, Week 76|The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline. The data presented are cumulative for events identified at each time point.||participants|||Number
172295|NCT00107042|Primary|Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))|Frequency Distribution of AEs by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as “Any” vs. “None”. In summarizing the distribution of AEs, the number of subjects with at least one event by preferred term and study arm were reported.|Week 12, Week 24, Week 28, Week 76|The safety and tolerability of each vaccine was assessed and reported among all enrolled participants (per-protocol) after baseline at each visit visit. The data presented are cumulative for events identified at each time point.||participants|||Number
172296|NCT00107042|Secondary|Quantitative Vaccine Response|The Log10 titer was used as the quantitative vaccine response.|Week 28|Subjects who had a wk 28 Hep B a'body titer and was no more than 8 wks after the 2nd vaccination were included. 1 subject was missing wk 28 titer. The a'body at week 48 was positive, so subject was treated as a responder for the binary measure. For the continuous a'body titer, the exact number could not be assumed; subject was treated as missing.||Log10 titer (mIU/ml)||Standard Deviation|Mean
172297|NCT00107042|Primary|Qualitative Seroresponsiveness to Hepatitis B Surface Antigen|"Seroresponsiveness to Hepatitis B Surface Antigen is defined as follows:~Responder: serum antibody level is greater than or equal to 10 mIU/mL. Non-responder: serum antibody level is less than 10 mIU/mL."|Week (Wk) 28 (One month after the second immunization)|Participants were included if they were vaccinated at least once (Intent-to-Treat)||Participants|||Number
172298|NCT00106964|Secondary|Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM|Response rate associated with the participant's study arm, baseline CD4 count, and interaction term that reflects how subjects in Arm 2 responded differently depending on their CD4 count. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.|Week 28|All participants who had a Week 28 Hepatitis B serology result||percentage of participants who responded|||Number
172299|NCT00106964|Secondary|Response Rates in HIV+ Youth Within Each Study Arm by Study Duration|Within each arm, the duration of response in HIV-infected youth was analyzed for all subjects who were responders at 28 weeks. The possible values for response duration could be 20 weeks or less (responder at 28 weeks but not at 48 weeks), 20 to 44 weeks (responder at 28 and 48 weeks but not at 72 weeks), or greater than 44 weeks (responder at 28, 48, and 72 weeks). A response of greater than 20 weeks includes those who responded after 20 weeks, but whose exact response duration was unknown.|Entry through Week 72|Population analyzed were those who had an antibody titer measured at Week 28.||percentage of participants who responded|||Number
172326|NCT00106704|Secondary|Change From Baseline in FPG at Week 24|The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.|Baseline and 24 Weeks|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data after rescue were considered missing.||mg/dL||95% Confidence Interval|Least Squares Mean
172300|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth – ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY|The number of adverse events and subjects with the events were described by study arm. The proportion of subjects with abnormal labs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in subjects with grade 3 or 4 toxicity. The laboratory events included are AEs classified as probably, possibly, or definitely related to study drug as classified by the Site Investigator.|Baseline through Week 72|All enrolled participants were included in this analysis. The following no. of participants experienced at least one Grade 2 or higher abnormal labs by study arm.||Events|Participants||Number
172301|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED|The number of AEs was described by study arm. The proportion of subjects with clinical AEs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3)were compared to assess whether or not there is a difference in subjects with any grade toxicity.|Baseline through Week 72|All enrolled participants were included in this analysis of AEs that were definitely related to study drug. There were no AEs above Grade 2 considered to be definitely related to study drug.||event|||Number
172302|NCT00106964|Secondary|Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED|The number of adverse events (AE) was described by study arm. The proportion of subjects with clinical adverse events in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in patients with any grade toxicity.|Baseline through Week 72|All enrolled participants were included in this analysis of all AEs that were possibly or probably related to study drug. There were no AEs above Grade 3 considered to be possibly or probably related to study drug.||Events|||Number
172303|NCT00106964|Primary|Sero-response to Hepatitis B Surface Antigen|The primary outcome, percentage positive sero-response, was compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) and measured 4 weeks after the third vaccination at Week 28. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.|Week 28|Participants who completed a Week 28 visit with a Hepatitis B serology result were included in this analysis.||percentage of participants who resonded|||Number
172304|NCT00106938|Secondary|Freedom From Mortality||0 to 1825 days|||percentage of participants|||Number
172305|NCT00106938|Secondary|Freedom From Mortality||0 to 1460 days|||percentage of participants|||Number
172306|NCT00106938|Secondary|Freedom From Mortality||0 to 1095 days|||percentage of partcipants|||Number
172307|NCT00106938|Secondary|Freedom From Mortality||0 to 730 days|||percentage of participants|||Number
172308|NCT00106938|Secondary|Freedom From Mortality||0 to 365 days|||percentage of participants|||Number
172309|NCT00106938|Secondary|Freedom From Ipsilateral Stroke||31 to 1825 days|||percentage of participants|||Number
172310|NCT00106938|Secondary|Freedom From Ipsilateral Stroke||31 to 1460 days|||percentage of participants|||Number
172311|NCT00106938|Primary|Composite of Any Death, Stroke, and MI Within 30 Days and Ipsilateral Stroke 31 Days to 365 Days|Major adverse events = Composite of any stroke, myocardial infarction and death during the 30-day post-procedural period and ipsilateral strokes between 31 and 365 days post-procedure.|0 to 365 days|||percentage of participants|||Number
172312|NCT00106938|Secondary|Freedom From Ipsilateral Stroke||31 to 1095 days|||percentage of participants|||Number
172313|NCT00106938|Secondary|Freedom From Ipsilateral Stroke||31 to 730 days|||percentage of participants|||Number
172314|NCT00106938|Secondary|Freedom From Ipsilateral Stroke||31 to 365 days|||percentage of participants|||Number
172315|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization||0 to 1825 days|||percentage of partcipants|||Number
172316|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization||0 to 1460 days|||percentage of partcipants|||Number
172317|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization||0 to 1095 days|||percentage of partcipants|||Number
172318|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization||0 to 730 days|||percentage of partcipants|||Number
172319|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization||0 to 365 days|||percentage of partcipants|||Number
172320|NCT00106938|Secondary|Freedom From Clinically Indicated Target Lesion Revascularization||0 to 180 days|||percentage of partcipants|||Number
172321|NCT00106938|Secondary|Composite Morbidity Measure|Composite Morbidity Measure = Cranial and peripheral nerve injury (cranial/cervical, femoral, peroneal, or other), vascular injury (including CAS access artery injury), non-cerebral bleeding, hematoma, or pseudoaneurysm, CEA wound or access artery wound, general anesthesia/allergic reaction/airway complications.|0 to 30 Days Post-procedure|ITT population||participants|||Number
172322|NCT00106938|Secondary|Procedural Success|"Procedural success is defined as the attainment of target lesion final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days.~Angiographic data was not required for CEA arm, therefore the procedure success assessment was not available for CEA arm."|0 to 30 days post procedure|||percentage of participants|||Number
172323|NCT00106938|Secondary|Acute Device Success: Embolic Protection Device System|Acute device success is defined as attainment of final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.|0 to 30 days post procedure|||percentage of devices|Participants|95% Confidence Interval|Number
172324|NCT00106938|Secondary|Acute Device Success: Xact Stent|Acute device success is defined as attainment of final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.|0 to 30 days post procedure|||percentage of devices|Participants|95% Confidence Interval|Number
172327|NCT00106704|Primary|Change From Baseline in A1C at Week 24|Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Baseline and 24 Weeks|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 24 for patients with no data at Week 24. Data obtained after glycemic rescue were considered missing.||Percent||95% Confidence Interval|Least Squares Mean
172328|NCT00106639|Secondary|Number of Participants With Discontinuation||Month 1, 2, 3, 4, 5, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172329|NCT00106639|Secondary|Electrocardiogram (ECG) Parameters|ECG parameters included PR interval, QT interval, corrected QT using Bazett's formula (QTcB) and QTc using Fridericia's formula (QTcF) interval, and QRS width.|Baseline, Month 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||millisecond||Standard Deviation|Mean
172330|NCT00106639|Secondary|Alanine Aminotransferase (ALT) Level|ALT is the enzyme found in the liver and it is measured to see if the liver is damaged or diseased.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||unit/liter||Standard Deviation|Mean
172331|NCT00106639|Secondary|Hematocrit Level|The hematocrit is recorded as the percentage of volume of red blood cells (RBCs) in a blood sample.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||percentage of blood||Standard Deviation|Mean
172332|NCT00106639|Secondary|Hemoglobin Level|Hemoglobin is the protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||g/dL||Standard Deviation|Mean
172333|NCT00106639|Secondary|Absolute Platelet Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points.||platelets*10^3/mm^3||Standard Deviation|Mean
172334|NCT00106639|Secondary|Total White Blood Cells (WBC), Absolute Basophil, Absolute Eosinophil, Absolute Lymphocyte, Absolute Monocyte, Absolute Neutrophil||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points.||cells*10^3/mm^3||Standard Deviation|Mean
172335|NCT00106639|Secondary|Number of Participants With Cytomegalovirus (CMV) Disease||Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication and based on time due to lost of follow-up, or up to Month 6. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||participants|||Number
172336|NCT00106639|Secondary|BK Virus (BKV) Deoxyribonucleic Acid (DNA) Load||Baseline, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||Copies/20 mcL plasma||Standard Deviation|Mean
172337|NCT00106639|Secondary|Epstein Barr Virus (EBV) and Cytomegalovirus (CMV) Deoxyribonucleic Acid (DNA) Load||Baseline, Month 1, 3, 6 for CMV; Baseline, Day 14, Month 1, 3, 6 for EBV|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||Copies/500 ng DNA||Standard Deviation|Mean
172338|NCT00106639|Secondary|Number of Participants With Drug Usage|Lipid lowering agents, antihypertensive agents, oral hypoglycemic agents (OHA) , anti-diabetic agents (ADA) and insulin drug usage was collected.|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||participants|||Number
172339|NCT00106639|Secondary|Supine Systolic and Diastolic Blood Pressure (BP)||Baseline, Day 2, 3, 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||millimeter of mercury||Standard Deviation|Mean
172340|NCT00106639|Secondary|Number of Participants With Hypertriglyceridemia|Hypertriglyceridemia was defined as a value of triglycerides greater than 200 mg/dL.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each group respectively.||participants|||Number
172341|NCT00106639|Secondary|Total Serum Cholesterol, Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL) Levels||Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||mg/dL||Standard Deviation|Mean
172342|NCT00106639|Secondary|Number of Participants With Hypercholesterolemia|Hypercholesterolemia is a condition characterized by very high levels of cholesterol in the blood. Hypercholesterolemia was defined as a value of total serum cholesterol greater than 240 mg/dL.|Baseline, Day 14, Month 1, 3, 6|Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||participants|||Number
172345|NCT00106639|Secondary|Number of Participants With First Clinically Significant Infection|Clinically significant (Viral, Bacterial and Fungal) infection was defined as the presence of presumed or documented infection confirmed by culture, biopsy, genomic or serologic findings post-randomization and required hospitalization or anti-infective treatment, or otherwise deemed significant by the Investigator.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172346|NCT00106639|Secondary|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 2 months after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to Month 8 (2 months follow-up)|Safety analysis set included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172347|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Reciprocal of Serum Creatinine (1/sCr)|GFR is a measure of renal function. The reciprocal of serum creatinine is an estimate of GFR.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points.||deciliter/mg (dL/mg)||Standard Deviation|Mean
172348|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease (MDRD) Equation|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using MDRD equation. GFR by MDRD equation= 170 * (serum creatinine) ^ (-0.999)*(age in years)^(-0.176)*(0.762 if female) * (1.18 if black)*(blood urea nitrogen concentration)^(-0.170)*(serum albumin concentration)^(0.318). Normal GFR is >90 mL/min/1.73 square meter (m^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each group respectively.||mL/min/1.73 m^2||Standard Deviation|Mean
172349|NCT00106639|Secondary|Glomerular Filtration Rate (GFR) by Cockcroft-Gault|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight*(140 minus age in years) divided by (72*serum creatinine). For females, value obtained was multiplied by 0.85. A normal GFR is >90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||mL/min||Standard Deviation|Mean
172350|NCT00106639|Secondary|Healthcare Resource Utilization Questionnaire (HCRUQ) - 5th Question|"Fifth question in the HCRUQ was “Upon discharge from the hospital, did you return to your previous place of residence?” and number of participants who responded yes or no to the question was reported."|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure.||participants|||Number
172351|NCT00106639|Secondary|Healthcare Resource Utilization Questionnaire (HCRUQ)|Healthcare Resource Utilization Questionnaire (HCRUQ) was used to assess healthcare resources which included number of events such as physician and other health professional visits, number of treatments or diagnostic tests, number of hospitalizations, and number of emergency room visits.|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||events||Standard Deviation|Mean
172352|NCT00106639|Secondary|End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL)|ESRD-SCL:43-item disease specific self-administered questionnaire. Participants’ rated question“At the moment,how much do you suffer?”for each item on 5 point scale,ranged (Ra) 0(not at all)to 4(extremely).Consisted of 6 subscales:cardiac and renal dysfunction;Ra 0-28,increased(In) growth of gum and hair;Ra 0-20,limited cognitive capacity;Ra 0-32,limited physical capacity;Ra 0-40,side effects (SEs) of corticosteroids;Ra 0-20,transplantation associated psychological distress(TAPD);Ra 0-32(higher scores=greater dysfunction for each subscale).Total score:0-172,higher scores=greater dysfunction.|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||units on a scale||Standard Deviation|Mean
172353|NCT00106639|Secondary|36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2)|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 “how would you rate your health in general now?” (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).|Baseline, Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||units on a scale||Standard Deviation|Mean
172354|NCT00106639|Secondary|Trough Levels of Tacrolimus (TAC)||Pre-dose on Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
172355|NCT00106639|Secondary|Reticulocyte Count|Reticulocytes are slightly immature red blood cells in the blood. Reticulocyte counts are reported as cells*10^3 per cubic millimeter (cells*10^3/mm^3).|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||cells*10^3/mm^3||Standard Deviation|Mean
172356|NCT00106639|Secondary|Fluorescence-Activated Cell Sorting (FACS) of Lymphocyte Subsets|The absolute cell counts of cluster of differentiation 8 (CD8): Cytotoxic T-lymphocytes reactive with major histocompatibility complex-1 (MHC-I), CD19: B- Lymphocytes, CD56: natural killer cells were determined using FACS, a specialized type of flow cytometry which sorts a heterogeneous mixture based upon the specific light scattering and fluorescent characteristics of each cell.|Baseline, Day 14, Month 1, 3, 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies participants evaluable for this measure and ‘n’ signifies those participants evaluable at specific time points for each arm group respectively.||cells per microliter (cells/mcL)||Standard Deviation|Mean
172357|NCT00106639|Secondary|Population Pharmacokinetics (PK)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Pre-dose on Day 1, 3, 7, 14, Month 1, 3, 6, between 1 to 2 hours post-dose at Month 3 and between 3 to 4 hours post-dose at Month 6||||||
172358|NCT00106639|Secondary|Number of Participants With Rejection|Rejection was defined as first occurrence of BPAR, antibody mediated rejection, or suspicious for acute rejection.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172359|NCT00106639|Secondary|Number of Participants Who Died||Month 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172360|NCT00106639|Secondary|Number of Participants With Graft Loss|Graft loss was defined as graft nephrectomy, participant's death due to graft loss, re-transplantation, or return to dialysis for greater than or equal to (>=) 6 consecutive weeks.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172361|NCT00106639|Secondary|Number of Participants With Efficacy Failure|Efficacy failure was the first occurrence of BPAR, graft loss or participant's death.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172362|NCT00106639|Secondary|Number of Participants With Ordered Categorical Severity of First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)|Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172363|NCT00106639|Secondary|Number of Participants With Ordered Categorical Severity of First Biopsy Proven Acute Rejection (BPAR)|Ordered categorical severity of first BPAR was classified according to the Banff Classification. Grade IA: moderate tubulitis, grade IB: severe tubulitis, grade IIA: mild to moderate intimal arteritis, grade IIB: severe intimal arteritis, grade III: transmural arteritis. (Racusen et al: The Banff classification, 1999).|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172364|NCT00106639|Secondary|Number of Participants With First Biopsy Proven Chronic Allograft Nephropathy (BPCAN)|BPCAN categorized as chronic allograft nephropathy as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172365|NCT00106639|Secondary|Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 3|BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Baseline up to Month 3|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172366|NCT00106639|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as the first occurrence of BPAR, graft loss, participant’s death or premature discontinuation of study medication for any reason.|Month 3, 6|FAS included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172367|NCT00106639|Primary|Glomerular Filtration Rate (GFR) by Nankivell Equation at Month 6|GFR: index of kidney function described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was calculated by creatinine clearance (CLcr) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine) plus (0.25*body weight) minus (0.5*serum urea) minus (100 per square height) plus (35 for male/25 for female). A normal GFR is >90 milliliter/minute (mL/min), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR <15 mL/min indicated kidney failure.|Month 6|FAS included all randomized participants who received at least 1 dose of study medication. Here, N (Number of participants analyzed) signifies those participants evaluable for this measure.||mL/min||Standard Deviation|Mean
172368|NCT00106639|Primary|Number of Participants With First Biopsy Proven Acute Rejection (BPAR) at Month 6|BPAR categorized as acute rejection as interpreted by the central blinded pathologist according to the Banff 97 working classification.|Baseline up to Month 6|Full analysis set (FAS) included all randomized participants who received at least 1 dose of study medication.||participants|||Number
172369|NCT00106626|Secondary|Safety and Tolerability as Measured by the Number of Participants With Disease Progression|Number of participants with disease progression (protocol-mandated reason for discontinuation). Disease progression was determined by the principle investigator.|Any time during 8 cycle treatment period through 30 days after.|All participants. Treated Population includes all participants who received at least one dose and had efficacy measurements at baseline and at least one post baseline treatment.||Participants|||Number
172568|NCT00106028|Secondary|Categorization by Number of New Morphometric Vertebral Fracture at Month 12, ITT|Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.|Baseline and Month 12|ITT Population||Participants|||Number
172370|NCT00106626|Primary|Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level|MTD was determined by the occurrence of DLTs during the first treatment cycle. DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The dose level is equal to the MTD if < 2 patients experience a DLT and is also the highest tolerated dose level in the cohort.|Cycle 1 (21 days)|A total of 52 participants were enrolled in this study. Six were violations pts (1 in Cohort C Dose Level 1, 1 in Cohort C Dose Level 2, 3 in Cohort D Dose Level 1, and 1 in Cohort D Dose Level 2) and were replaced. None of the violations pts had any DLTs in the first cycle of the study.||Participants|||Number
172371|NCT00106535|Secondary|End of Study: Change From Baseline in Joint Space Narrowing Score at Week 260|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation.||Score on a scale||Standard Deviation|Mean
172372|NCT00106535|Secondary|End of Study: Change From Baseline in Erosion Score at Week 260|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot and were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best ) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data.||Score on a scale||Standard Deviation|Mean
172373|NCT00106535|Secondary|End of Study: Change From Baseline in Total Sharp-Genant Score at Week 260|Radiographs were taken of each hand and foot at Baseline and Week 260 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint).The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. The results were reported based on the treatment the patient was originally randomized to.|Baseline, Week 260|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline, Week 104 and post-Week 104 radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data.||Score on a scale||Standard Deviation|Mean
172374|NCT00106535|Secondary|End of Study: Percentage of Participants With Clinical Relevant Improvement in the SF-36 Score at Week 260|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. Clinically relevant improvement is defined as a ≥5 change from Baseline.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available for analysis at Baseline and Week 260.||Percentage of participants|||Number
172375|NCT00106535|Secondary|End of Study: Percentage of Participants With Clinical Improvement in the FACIT-Fatigue Score at Week 260|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5 change from Baseline.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available for analysis at Baseline and Week 260.||Percentage of participants|||Number
172376|NCT00106535|Secondary|End of Study: Change From Baseline in the Patient's Pain VAS at Week 260|"The patient assessed their pain at Baseline and Week 260 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.||mm||Standard Deviation|Mean
172377|NCT00106535|Secondary|End of Study: Change From Baseline in the Physician's Global Assessment of Disease Activity VAS at Week 260|The physician’s global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.||mm||Standard Deviation|Mean
172441|NCT00106535|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 104|Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 104 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||mg/dL||Standard Deviation|Mean
172378|NCT00106535|Secondary|End of Study: Change From Baseline in the Patient's Global Assessment of Disease Activity Visual Analog Scale (VAS) at Week 260|"The patient's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 260|Participants from the Modified Intent-to-treat population, all tocilizumab exposure group, with data available at Baseline and Week 260. No imputation was used for missing VAS assessments.||mm||Standard Deviation|Mean
172379|NCT00106535|Secondary|End of Study: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 260|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. No imputation was used for missing HAQ score.||Score on a scale||Standard Deviation|Mean
172380|NCT00106535|Secondary|End of Study: Change From Baseline in Tender Joint Count at Week 260|68 joints were assessed at Baseline and Week 260 for tenderness and joints are classified as tender/not tender for a total possible swollen joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. Last observation carried forward was used for missing joint counts.||Joint Count||Standard Deviation|Mean
172381|NCT00106535|Secondary|End of Study: Change From Baseline in Swollen Joint Count at Week 260|66 joints were assessed at Baseline and Week 260 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 260|Participants from the Modified Intent-to-treat population, All Tocilizumab Exposure group, with data available at Baseline and Week 260. Last observation carried forward was used for missing joint counts.||Joint Count||Standard Deviation|Mean
172382|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 European League Against Rheumatism (EULAR) Good or Moderate Response at Week 260|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm), and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement. EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2.|Baseline, Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.||Percentage of participants|||Number
172383|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 Low Disease Activity (LDA) at Week 260|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDA is defined as DAS28 ≤3.2.|Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.||Percentage of participants|||Number
172384|NCT00106535|Secondary|End of Study: Percentage of Participants With DAS28 Remission at Week 260|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Week 260. Last observation carried forward was used for tender and swollen joint counts. No imputation used for ESR and Patients Global Assessment of Disease Activity VAS.||Percentage of participants|||Number
172385|NCT00106535|Secondary|End of Study: Percentage of Participants With ACR Response at Week 260|ACR20/50/70/90 response is defined as a ≥ 20/50/70/90% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 260|Participants from the Modified Intent-to-treatment population, all exposure group, with data available at Baseline and Week 260. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments.||Percentage of participants|||Number
172692|NCT00105196|Other Pre-specified|Clinical Global Impression (CGI)-Improvement Response|Number of subjects with response relative to Week 8 (baseline). Response defined as score of 1 (very much improved) or 2 (much improved) on a 7-point, ordinal scale (1=very much improved; 7=very much worse).|Baseline (Week 8) and Week 14|||Participants|||Number
172386|NCT00106535|Secondary|Percentage of Participants Who Achieved Complete Clinical Response at Week 104|Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria [defined as five of the following criteria are met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR < 30 mm/hr for a female or 20 mm/hr for a male] and no radiographic progression [defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score].|104 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
172387|NCT00106535|Secondary|Percentage of Participants Who Achieved Complete Clinical Response at Week 52|Complete clinical response is defined as a continuous 6-month period of remission by ACR criteria [defined as five of the following criteria are met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or swelling, and ESR < 30 mm/hr for a female or 20 mm/hr for a male] and no radiographic progression [defined as change from baseline ≤ 0 in the total Sharp-Genant score, erosion score, and JSN score]. Patients who achieve a complete clinical response at any time in the study are counted as responders, even if the response is not maintained.|52 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew or where an ACR could not be calculated, were set to ’Non Responder’.||Percentage of participants|||Number
172388|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 104|The percentage of participants who achieved ACR remission at any study visit up to Week 104. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|104 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to 'Non Responder'.||Percentage of participants|||Number
172389|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 52|The percentage of participants, who achieved ACR remission at any study visit up to Week 52. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|52 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to 'Non Responder'.||Percentage of participants|||Number
172390|NCT00106535|Secondary|Percentage of Participants Who Achieved Remission According to the ACR Remission Criteria by Week 24|The percentage of participants, who achieved ACR remission at any study visit up to Week 24. ACR remission required that all five of the following criteria were met for at least two consecutive months: morning stiffness < 15 minutes, no fatigue, no joint pain, no joint tenderness or pain on motion, no soft tissue swelling in joints or tendon sheaths, and ESR < 30 mm/hr for a female or 20 mm/hr for a male.|24 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for morning stiffness, FACIT-Fatigue score, ESR and VAS assessment. Patients with missing data, early withdrawal or who received escape therapy were set to ’Non Responder’.||Percentage of participants|||Number
172391|NCT00106535|Secondary|Percentage of Participants in Each Treatment Group Who Receive Escape Therapy|"In Escape 1, participants in the Tocilizumab 4 mg/kg + Methotrexate and Tocilizumab 8 mg/kg + Methotrexate groups received tocilizumab 8 mg/kg as escape therapy. Participants in the Placebo + Methotrexate group received tocilizumab 4 mg/kg as escape therapy.~In Escape 2, all participants received tocilizumab 8 mg/kg."|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis.||Percentage of participants|||Number
172392|NCT00106535|Secondary|Percentage of Participants Who Withdraw Due to Lack of Sufficient Therapeutic Response|Insufficient therapeutic response (patient not responding to the drug as assessed by the physician) was selected by the investigator as a reason that the patient withdrew from the study.|104 Weeks|Intent-to-treat population included all randomized participants who received at least 1 dose of study drug. Data on escape therapy is excluded.||Percentage of participants|||Number
172393|NCT00106535|Secondary|Time to Onset of ACR70 by Treatment Group|Time in days until ACR70 response. ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR70 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.||Days||95% Confidence Interval|Median
172569|NCT00106028|Secondary|New Morphometric Vertebral Fracture at Month 36, ITT Population|Morphometric Vertebral Fracture measured by SQ analysis of x-rays using the Genant scoring system. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.|Baseline and Month 36|ITT Population||Participants|||Number
172394|NCT00106535|Secondary|Time to Onset of ACR50 by Treatment Group|Time in days until ACR50 response. ACR50 response was defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR50 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.||Days||95% Confidence Interval|Median
172395|NCT00106535|Secondary|Time to Onset of ACR20 by Treatment Group|Time in days until ACR20 response. ACR20 response was defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|6 months|Participants from the ITT population [N=393,399,398] (all randomized participants who received study drug) with ACR20 response. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who withdrew, received escape therapy or who did not achieve a response were censored.||Days||95% Confidence Interval|Median
172396|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 104 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 104 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||IU/mL||Standard Deviation|Mean
172397|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 52 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 52 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||IU/mL||Standard Deviation|Mean
172398|NCT00106535|Secondary|Change From Baseline in Rheumatoid Factor (RF) at Week 24 in Those Patients With Positive RF|Blood was collected for Rheumatoid Factor (RF) at Baseline and Week 24 and was analyzed at a central laboratory. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. A lower number change from Baseline indicated a better result.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with positive RF at Baseline. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||IU/mL||Standard Deviation|Mean
172399|NCT00106535|Secondary|Change From Baseline in FACIT-F Score at Week 104|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172400|NCT00106535|Secondary|Change From Baseline in FACIT-F Score at Week 52|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172417|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 104|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.||Score on a scale||Standard Deviation|Mean
172401|NCT00106535|Secondary|Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Score at Week 24|FACIT-F is a 13-item questionnaire. Patients scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the patient's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the patient's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the patient's health status.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing FACIT-Fatigue scores. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172402|NCT00106535|Secondary|Change From Baseline in SF-36 Score at Week 104|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172403|NCT00106535|Secondary|Change From Baseline in SF-36 Score at Week 52|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from Baseline indicates improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. Data was set to missing for patients who received escape therapy.||Score on a scale||Standard Deviation|Mean
172404|NCT00106535|Secondary|Change From Baseline in Quality Life Short Form-36 (SF-36) Score at Week 24|The SF-36 is a questionnaire used to assess physical functioning and is made up of eight domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. Transforming and standardizing these domains leads to the calculation of the Physical (PCS) and Mental (MCS) Component Summary measures. Scores ranging from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.|Baseline, Week 24|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. . Data was set to missing for patients who received escape therapy.||Score on a scale||Standard Deviation|Mean
172405|NCT00106535|Secondary|Change From Baseline in HAQ Disability Index at Week 104|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8). Total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172406|NCT00106535|Secondary|Change From Baseline in HAQ Disability Index (HAQ-DI) at Week 52|HAQ-DI is a self-completed questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. To Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172407|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 104|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.||Percentage of participants|||Number
172418|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 80|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.||Score on a scale||Standard Deviation|Mean
172408|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 52|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score is defined as a change from Baseline of less than or equal to zero.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.||Percentage of participants|||Number
172409|NCT00106535|Secondary|Percentage of Participants With no Progression of Joint Space Narrowing at Week 24|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). No progression of Joint Space Narrowing score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdrawal or on escape therapy was excluded.||Percentage of participants|||Number
172410|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 104|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdrawal or on escape therapy was excluded.||Percentage of participants|||Number
172411|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 52|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.||Percentage of participants|||Number
172412|NCT00106535|Secondary|Percentage of Participants With no Progression of Erosion at Week 24|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). No progression of Erosion score was defined as a change from Baseline of less than or equal to zero.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdraw or on escape therapy was excluded.||Percentage of participants|||Number
172413|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 104|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.||Score on a scale||Standard Deviation|Mean
172414|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 80|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.||Score on a scale||Standard Deviation|Mean
172415|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 52|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Missing data was imputed using linear extrapolation. Data collected after withdraw or on escape therapy was excluded.||Score on a scale||Standard Deviation|Mean
172416|NCT00106535|Secondary|Change From Baseline in Joint Space Narrowing Score at Week 24|Radiographs were taken of a total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint) for a total possible score of 0 (best) to 148 (worst). A lower change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data was set to missing for patients who withdrew or received escape therapy.||Score on a scale||Standard Deviation|Mean
173550|NCT00095498|Secondary|Change From Baseline in Platelets at Month 6|Laboratory hematology platelets|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
172419|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 52|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data for this outcome measure. Missing Week 52 data was imputed using Linear extrapolation. Data was set to missing for patients who withdrew or received escape therapy.||Score on a scale||Standard Deviation|Mean
172420|NCT00106535|Secondary|Change From Baseline in Erosion Score at Week 24|Radiographs were taken of a total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion for a total possible score of 0 (best) to 142 (worst). A lower number change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data was set to missing for patients who withdrew or received escape therapy.||Score on a scale||Standard Deviation|Mean
172421|NCT00106535|Secondary|Change From Baseline in Modified Total Sharp-Genant Score at Week 80|Radiographs were taken of each hand and foot at Baseline and Week 80 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 80|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing data. Data collected after withdraw or on escape therapy is excluded.||Score on a scale||Standard Deviation|Mean
172422|NCT00106535|Secondary|Change From Baseline in Modified Total Sharp-Genant Score at Week 24|Radiographs were taken of each hand and foot at Baseline and Week 24 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdraw or on escape therapy is excluded.||Score on a scale||Standard Deviation|Mean
172423|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 104|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Standard Deviation|Mean
172424|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 52|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|52 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Standard Deviation|Mean
172425|NCT00106535|Secondary|Area Under Curve (AUC) of Disease Activity Score (DAS28) at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. Higher calculated AUC values are worse (indicate higher disease activity).|24 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Standard Deviation|Mean
172482|NCT00106431|Primary|The Percent of Patients (Pts) With Objective Disease Response|The percent of pts with confirmed Objective Disease Response (confirmed best responses of complete response [CR], clinical complete response [CCR], or partial response [PR]). Responses were evaluated according to a composite assessment (Objective Primary Disease Response Evaluation Criteria - OPDREC).|6 months|Efficacy analysis based on interim analysis of data for as treated population||Percent of participants|||Number
172426|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 104|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.|Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Percentage of participants|||Number
172427|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 52|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control.DAS28 Remission is defined as a DAS28 score <2.6.|Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Percentage of participants|||Number
172428|NCT00106535|Secondary|Percentage of Participants With DAS28 Remission at Week 24|The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR). DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 remission is defined as a DAS28 score <2.6.|Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Percentage of participants|||Number
172429|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 104|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.~EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 104|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation was used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.||Percentage of participants|||Number
172430|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 52|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity (mm) [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.~EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 52|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.||Percentage of participants|||Number
172431|NCT00106535|Secondary|Percentage of Participants With DAS28 Good or Moderate EULAR Response at Week 24|"The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] , and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.~European League Against Rheumatism (EULAR) Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2.~EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2."|Baseline, Week 24|ITT population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. For patients who received escape therapy, withdrew prematurely or where the DAS28 score was missing the response was set to 'No response'.||Percentage of participants|||Number
172432|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 104|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172693|NCT00105196|Other Pre-specified|MADRS Response|Number of subjects with a ≥50 percent reduction from Week 8 (baseline) in MADRS Total Score, a 10-item, ordinal rating scale to assess the severity of depressive symptoms (0=no symptoms; 60=most severe symptoms).|Baseline (Week 8) and Week 14|||participants|||Number
172433|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 52|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172434|NCT00106535|Secondary|Change From Baseline in Disease Activity Score (DAS28) at Week 24|The DAS28 score is a measure of the subject's disease activity. It is based on the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity], and ESR. DAS28 total scores range from 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172435|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn Score at Week 104|The ACRn is defined as each patient’s lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 104. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|104 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Standard Deviation|Mean
172436|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn to Week 52|The ACRn is defined as each patient’s lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 52. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|52 Weeks|Participants from the Intent-to-treat population(all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Full Range|Least Squares Mean
172437|NCT00106535|Secondary|Area Under Curve (AUC) of the ACRn to Week 24|The ACRn is defined as each patient’s lowest percent improvement from Baseline of 3 measures: tender joint count (68 joints), swollen joint count (66 joints), and the improved score achieved in at least 3 of the 5 remaining ACR core components (physician global assessment, patient global assessment, pain, HAQ, and C-reactive protein or ESR, respectively). AUC of ACRn, a continuous variable, was calculated from Baseline to Week 24. A positive score change from Baseline indicated an improvement. The higher the ACRn score the better.|24 Weeks|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ score, CRP, ESR and VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale*week||Standard Deviation|Mean
172438|NCT00106535|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 104|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do).HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||Percentage of participants|||Number
172439|NCT00106535|Secondary|Percentage of Participants Who Achieve an Improvement of at Least 0.3 Units From Baseline in the HAQ Disability Index at Week 52|The Stanford Health Assessment Questionnaire disability index (HAQ-DI) is a patient completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). HAQ-DI=sum of worst scores in each domain divided by the number of domains answered for a total possible score of 0 (best) to 3 (worst).|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing for patients who received escape therapy.||Percentage of participants|||Number
172440|NCT00106535|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 104|Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 104 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing data. All assessments were set to missing from the time a patient received escape therapy.||mm/hr||Standard Deviation|Mean
172442|NCT00106535|Secondary|Change From Baseline in the Patient's Pain VAS at Week 104|"The patient assessed their pain at Baseline and Week 104 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as no pain and the right-hand extreme equals 100 mm as unbearable pain. A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172443|NCT00106535|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity at Week 104|"The physician's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172444|NCT00106535|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 104|"The patient's global assessment of disease activity was assessed at Baseline and Week 104 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as maximum disease activity (maximum arthritis disease activity). A negative change from Baseline indicated improvement."|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy||Score on a scale||Standard Deviation|Mean
172445|NCT00106535|Secondary|Change From Baseline in Tender Joint Count at Week 104|68 joints were assessed for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for tender joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||Joint count||Standard Deviation|Mean
172446|NCT00106535|Secondary|Change From Baseline in Swollen Joint Count at Week 104|66 joints were assessed at Baseline and Week 104 for swelling and joints were classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 104|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||Joint count||Standard Deviation|Mean
172447|NCT00106535|Secondary|Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52|Blood was collected for Erythrocyte Sedimentation Rate (ESR) at Baseline and Week 52 and was analyzed at a local laboratory. ESR was measured in millimeters/hour (mm/hr). A reduction in the level is considered an improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing data. Data was set to missing for patients who received escape therapy.||mm/hr||Standard Deviation|Mean
172448|NCT00106535|Secondary|Change From Baseline in C-Reactive Protein (CRP) at Week 52|Blood was collected for C-Reactive Protein (CRP) at Baseline and Week 52 and was analyzed at a central laboratory. The serum concentration of CRP was measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was made for missing data. All assessments were set to missing from the time a patient received escape therapy.||mg/dL||Standard Deviation|Mean
172449|NCT00106535|Secondary|Change From Baseline in the Patient's Pain VAS at Week 52|The patient assessed their pain at Baseline and Week 52 using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. Data was set to missing for patients who received escape therapy.||Score on a scale||Standard Deviation|Mean
172450|NCT00106535|Secondary|Change From Baseline in Physicians Global Assessment of Disease Activity at Week 52|The physician’s global assessment of disease activity was assessed using a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing after the patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172451|NCT00106535|Secondary|Change From Baseline in Patient's Global Assessment of Disease Activity at Week 52|The patient’s global assessment of disease activity is assessed at Baseline and Week 52 using a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||Score on a scale||Standard Deviation|Mean
172452|NCT00106535|Secondary|Change From Baseline in Tender Joint Count at Week 52|68 joints were assessed at Baseline and Week 52 for tenderness and joints were classified as tender/not tender for a total possible tender joint count of 0 (best) to 68 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for missing tender joint data. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||Joint count||Standard Deviation|Mean
172453|NCT00106535|Secondary|Change From Baseline in Swollen Joint Count at Week 52|66 joints were assessed at Baseline and Week 52 for swelling and joints are classified as swollen/not swollen for a total possible swollen joint count of 0 (best) to 66 (worst). A negative change from Baseline indicated improvement.|Baseline, Week 52|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||Joint count||Standard Deviation|Mean
172454|NCT00106535|Secondary|Percentage of Participants With ACR70 Response Maintained for 6 Consecutive Months|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|104 Weeks|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
172455|NCT00106535|Secondary|Percentage of Participants With ACR70 Response at Week 104|ACR50 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
172456|NCT00106535|Secondary|Percentage of Participants With ACR70 Response at Week 52|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
172457|NCT00106535|Secondary|Percentage of Participants With ACR50 Response at Week 104|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
172471|NCT00106535|Secondary|Tender Joint Count (68 Joint Count): Mean Change From Baseline at Week 24|68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||joint count||Standard Deviation|Mean
172458|NCT00106535|Secondary|Percentage of Participants With ACR50 Response at Week 52|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
172459|NCT00106535|Secondary|Percentage of Participants With ACR20 Response at Week 104|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 104|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
172460|NCT00106535|Secondary|Percentage of Participants With American College of Rheumatology (ACR20) Response at Week 52|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 52|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
172461|NCT00106535|Primary|Change in Physical Function as Measured by the Area Under the Curve for the Change From Baseline in the Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 104|HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 2 years by using the AUC of the change from baseline in HAQ-DI score through week 104. Decreases in AUC of change from baseline in HAQ-DI indicated a gr eater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 104 HAQ-DI score, the AUC of the change from baseline was standardized to 104 weeks using the latest timepoint available for calculation of the AUC. A negative change from baseline indicated improvement.|Baseline to Week 104|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing HAQ scores. For patients who received escape therapy, the HAQ-DI was set to missing from the time they entered escape.||Score on a scale*week||Full Range|Least Squares Mean
172462|NCT00106535|Primary|Change From Baseline in the Modified Total Sharp-Genant Score at Week 104|Radiographs of each hand and foot were taken at Baseline and Week 104 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 104|Participants from the Intent-to-treat population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Data collected after withdrawal or for patients on escape therapy the data is excluded. Missing data was imputed using linear extrapolation.||Score on a scale||Standard Deviation|Mean
172472|NCT00106535|Secondary|Swollen Joint Count (66 Joint Count): Mean Change From Baseline at Week 24|66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.|Baseline, Week 24|Participants from the Intent-to-treat population (all randomized participants who received study drug) with data available for analysis. LOCF was used for swollen joint counts. All assessments were set to missing from the time a patient received escape therapy and only pre-escape therapy joint count assessments were carried forward.||joint count||Standard Deviation|Mean
172463|NCT00106535|Primary|Change in Physical Function as Measured by the Area Under the Curve (AUC) for the Change From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 52|HAQ-DI consisted of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities rated on a 4-point scale where 0=without any difficulty to 3=unable to do. The sum of scores was divided by the number of domains with a score for a total possible score of 0 (best) to 3 (worst). Functional disability was determined as a cumulative measure of HAQ-DI over 1 year by using the AUC of the change from baseline in HAQ-DI score through week 52. Decreases in AUC of change from baseline in HAQ-DI indicate a greater average improvement in physical function over time and represent a decrease in sustained impairment. For patients with missing week 52 HAQ-DI score, the AUC of the change from baseline was standardized to 52 weeks using the latest timepoint available for calculation of the AUC. The mean was adjusted for region. A negative change from baseline indicated improvement.|Baseline to Week 52|Participants from the Intent-to-treat population (all randomized participants who received at least one dose of study drug) with data available for analysis. No imputation was used for missing HAQ scores. All assessments were set to missing after a patient received escape therapy.||Score on a scale*week||Full Range|Least Squares Mean
172464|NCT00106535|Primary|Change From Baseline in Modified Total Sharp-Genant Score at Week 52|Radiographs were taken of each hand and foot at Baseline and Week 52 and evaluated at a central reading service by two independent radiologists using the Genant modified method according to Sharp. Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Joint Narrowing Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). The maximum total erosion score in the hands is 100 (normalized from 98) and in the feet 42, the maximum scores for joint space narrowing in the hands is 100 (normalized from 104) and in the feet 48. The maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score.|Baseline, Week 52|Participants from the Intent-to-treat (ITT) population, all randomized participants who received at least one dose of study drug, with Baseline and post-Baseline radiographic data available for this outcome measure. Linear extrapolation was used to impute missing week 52 data. Data collected after withdrawal or on escape therapy is excluded.||Score on a scale||Standard Deviation|Mean
172465|NCT00106535|Secondary|Health Assessment Questionnaire Disability Index (HAQ-DI): Mean Change From Baseline at Week 24|HAQ-DI is a self-completed patient questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Calculate HAQ-DI the patient must have a domain score for at least 6 of 8 domains. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing HAQ-DI. All assessments were set to missing from the time a patient received escape therapy.||Scores on a scale||Standard Deviation|Mean
172466|NCT00106535|Secondary|Erythrocyte Sedimentation Rate: Mean Change From Baseline at Week 24|The Erythrocyte Sedimentation Rate (ESR) was measured in mm/hr. A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing ESR. All assessments were set to missing from the time a patient received escape therapy.||millimeters/hour (mm/hr)||Standard Deviation|Mean
172467|NCT00106535|Secondary|C-Reactive Protein (CRP): Mean Change From Baseline at Week 24|The serum concentration of C-Reactive Protein (CRP) is measured in mg/dL. A reduction in the level is considered an improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing CRP. All assessments were set to missing from the time a patient received escape therapy.||milligrams/deciliter (mg/dL)||Standard Deviation|Mean
172468|NCT00106535|Secondary|Patient's Pain VAS: Mean Change From Baseline at Week 24|The patient assessed their pain on a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS). The left-hand extreme of the line equals 0 mm, and is described as “no pain” and the right-hand extreme equals 100 mm as “unbearable pain”. A negative change indicated improvement.|Baseline and Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||mm||Standard Deviation|Mean
172469|NCT00106535|Secondary|Physician's Global VAS: Mean Change From Baseline at Week 24|The physician’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the physician. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as “maximum disease activity” (maximum arthritis disease activity).|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||mm||Standard Deviation|Mean
172470|NCT00106535|Secondary|Patient's Global Visual Analog Scale (VAS): Mean Change From Baseline at Week 24|The patient’s global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the patient. The left-hand extreme of the line equals 0 mm, and is described as “no disease activity” (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as “maximum disease activity” (maximum arthritis disease activity). A negative change from Baseline indicated improvement.|Baseline, Week 24|Participants from the Intent-to-treat population, all randomized participants who received study drug, with data available for analysis. No imputation was used for missing VAS assessments. All assessments were set to missing from the time a patient received escape therapy.||millimeters (mm)||Standard Deviation|Mean
176535|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 8||Baseline to Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
172473|NCT00106535|Secondary|Percentage of Participants With ACR70 Response|ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline,Week 24|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
172474|NCT00106535|Secondary|Percentage of Participants With ACR50 Response|ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant [either C-reactive protein or Erythrocyte Sedimentation Rate].|Baseline, Week 24|Intent-to-treat population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
172475|NCT00106535|Primary|Percentage of Participants With American College of Rheumatology-ACR20 Response|ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient’s Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient’s Global Assessment of Disease Activity and Physician’s Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant, either C-reactive protein or Erythrocyte Sedimentation Rate.|Baseline, Week 24|Intent-to-treat (ITT) population included all randomized participants who received study drug. LOCF was used for tender and swollen joint counts, no imputation used for missing HAQ Score, CRP, ESR and VAS assessments. Patients who received escape therapy, withdrew prematurely or where an ACR could not be calculated, were set to 'Non Responder'.||Percentage of participants|||Number
172476|NCT00106431|Secondary|Percent of Pts With Objective Disease Control|The percent of pts with confirmed ODC (CR, CCR, PR and SD90) based on OPDREC was summarized.|Up to 10 months|Efficacy analysis based on interim analysis of data for as treated population||Percent of participants|||Number
172477|NCT00106431|Secondary|Duration of Objective Disease Control (ODC)|For pts with confirmed ODC (pts with CR, CCR, PR, SD90 [stable disease for 90 days]) based on OPDREC, duration of ODC was summarized with descriptive statistics, including number of censored observations, and 25th, 50th, 75th percentiles of distribution, based on Kaplan-Meier product limit estimates. For pts with confirmed progressive disease (PD), duration of ODC was calculated from first date of study drug to first date of diagnosis of confirmed PD. For pts without confirmed PD, duration of ODC was calculated from first date of study drug to date of the last visit with any OPDREC data.|Up to 10 months; median duration of follow up was 6.0 months|Efficacy analysis based on interim analysis of data for as treated population||Months||Full Range|Median
172478|NCT00106431|Secondary|Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles.|Pruritus was reported monthly by pts using a 0 (no itching) to 100 (unbearable itching) mm visual analog scale (VAS). Pts were considered to have significant pruritus if the baseline VAS score was ≥ 30 mm. Clinically meaningful reduction in pruritus was defined as a decrease in VAS score of ≥ 30 mm or a score of 0 for at least 2 consecutive cycles.|Up to 10 months|Patients meeting definition of moderate to severe pruritus on VAS (i.e., had a VAS of >=30 mm)||participants|||Number
172479|NCT00106431|Secondary|Time to Disease Progression|Time To Progression was defined as the duration from the date of the first study drug dose to the date of progression (PD). In this analysis, pts who did not progress were censored at their last evaluation with an OPDREC assessment.|Up to 10 months; median duration of follow up was 6.1 months|Efficacy analysis based on interim analysis of data for as treated population||Months||Full Range|Median
172480|NCT00106431|Secondary|Time to Objective Disease Response|Time to Objective Response was defined as the time in months from first dose date to the first date of objective disease response (later confirmed) and time to CCR was defined as the time in months from first dose date to the first date of CCR (later confirmed).|Up to 10 months|Efficacy analysis based on interim analysis of data for as treated population||Months||Full Range|Median
172481|NCT00106431|Secondary|Duration of Objective Disease Response|Duration of Objective Response was defined as the number of months from the date of the first disease response (clinical complete response [CCR], or partial response [PR]) (later confirmed) until the date of progression and was determined using Kaplan-Meier product-limit estimates. In this analysis, pts who did not progress were censored as of their last evaluation with an OPDREC assessment.|Up to 10 months; median duration of follow up was 5.1 months|Efficacy analysis based on interim analysis of data for as treated population||Months||Full Range|Median
176536|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 4||Baseline to Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
172483|NCT00106392|Secondary|Continence Level as Quantified by Part I of the Prostate Health-Related Quality of Life Questionnaire|Part 1 Urinary Function- Prostate Health-Related Quality-of-Life (QOL) Questionnaire consists of 16 questions asking patients about their continence and urinary habits over the previous four weeks. The responses to all 16 of these questions were added together to calculate an overall score for urinary function. The minimum possible score is 16 and the maximum possible score is 79. A higher score indicates a lower continence level.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants with a Prostate Health-Related QOL questionnaire at 24 months were included in the calculation."||Overall Score of Urinary Function||Full Range|Median
172484|NCT00106392|Secondary|Time to Achieve Response to Impotence Medications|Time to achieve response to impotence medication was calculated based on the date of the assessment during which the first successful response was recorded. The specific date of the actual response is not reflected; only that it occurred since the previous study visit.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants who had a successful response to impotence medications were included in the calculations."||Days||Full Range|Median
172485|NCT00106392|Secondary|Percentage of Patients Considered Successful Responders to Impotence Medications|Patients were identified as successful responders if they answered affirmatively in the Patient Sexual Encounter Diary regarding successful sexual intercourse after using impotence medication.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants who used any impotence medications were included in the calculation."||Percentage of Participants|||Number
172486|NCT00106392|Secondary|Time Taken to Achieve Normalization of the Erectile Function (EF) Domain Score|Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The EF domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. Scores range from 1-30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.Time to achieve normalization of the EF domain score was calculated based on the date of the assessment during which the EF domain score was first greater than or equal to 24.|24 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants who achieved normal erectile function are included in the calculation."||Days||Full Range|Median
172487|NCT00106392|Secondary|Percentage of Patients Achieving Normal Spontaneous Erectile Function as Measured by the Erectile Function (EF) Domain Score|"Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.~Percentages represent the proportions of participants who achieved normal erectile function at any time during the 24 months."|24 months|The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.||Percentage of Participants|||Number
172488|NCT00106392|Primary|Erectile Function Domain Score Between Treated and Untreated Groups|Erectile function was assessed using the International Index of Erectile Function (IIEF) questionnaire, which consists of 15 questions. The erectile function domain score is calculated as a sum of scores from questions 1-5 and 15. A clinically meaningful difference is 5 points. The scores range from 1 to 30 points where a higher score indicates better erectile function. Normal erectile function is defined as greater than or equal to 24 points.|18 months|"The number of participants analyzed represents Full Analysis Set (FAS), which is defined as participants evaluated for Efficacy and Safety.~Only participants with complete IIEF questionnaire data at 18 months are included in the calculation."||Erectile Function Domain Score||Full Range|Median
172489|NCT00106353|Secondary|Number of Participants for Change From Baseline in the Phosphorylation of Mammalian Target of Rapamycin (mTOR) Pathway Proteins: Part 1 and Part 2|Optional bone marrow sampling for pharmacodynamic analysis of effects of study treatment. Data may not be collected for a majority of patients and was not to be summarized if collection was sparse.|Part 1:Baseline,1,2,6,24,168 hrs post-dose of Cycle 1;additional 0 (Pre-dose),24,72,96 hrs, Day 16 to 21 of cycle 2, EOT(within 30 days of last dose); Part 2:Baseline,Day16 to 21 in Cycle 2, at time of disease progression, EOT(within 30 days of last dose)|Data was not analyzed.|||||
172490|NCT00106353|Secondary|Concentration in Plasma (Cp) and Concentration in Plasma at Time Zero (Cp Time 0): Part 1 and Part 2|Pharmacokinetic parameters determined in whole blood; derived from the concentration-versus-time profiles using noncompartmental analysis method. Measured as nanograms per milliliter (ng/mL).|Part 1: 0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2; Part2: 0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Data was not analyzed.|||||
172491|NCT00106353|Secondary|Clearance (CL): Part 2|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||L/hr||Standard Deviation|Mean
172492|NCT00106353|Secondary|Area Under the Concentration-time Curve at Steady State (AUCss): Part 2|AUCss is a measure of the serum concentration of the drug at steady state. It is used to characterize drug absorption.|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hr*ng/mL||Standard Deviation|Mean
172565|NCT00106028|Secondary|Incidence New Vertebral Fractures by SQ Score, Patients Aged 10-15 Years, Month 12, ITT Population|Patients aged 10-15 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.|Month 12|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data||Participants|||Number
172493|NCT00106353|Primary|Percentage of Participants With Objective Response (OR) at Week 12: Part 2|Measured as Complete response (CR), Very good partial response (VGPR), or Partial response (PR) on at least 2 occasions greater than or equal to (>=) 4 weeks apart within first 12 weeks. CR=disappearance of all primary and metastatic lesions; Homovanillic acid, Vanillymandelic acid (HVA/VMA) normal; bone marrow immunocytology negative. VGPR=disappearance of all metastatic lesions (residual areas of uptake on bone permitted); 90 to 99 percent (%) decrease in primary disease measurement; HVA/VMA normal or both decreased >90%. PR=at least 50% decrease in primary and metastatic disease. Number of bone sites decreased by at least 50%.|Week 12|Efficacy evaluable population included all participants who received at least 3 doses of study treatment. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||percentage of participants|||Number
172494|NCT00106353|Primary|Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 1|Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172495|NCT00106353|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 2|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hr*ng/mL||Standard Deviation|Mean
172496|NCT00106353|Secondary|Plasma Decay Half-Life (t1/2): Part 2|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for.||hr||Standard Deviation|Mean
172497|NCT00106353|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 2||0 (pre-dose),1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||hr||Full Range|Median
172498|NCT00106353|Secondary|Average Plasma Concentration (Cavg): Part 2||0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
172499|NCT00106353|Secondary|Maximum Observed Plasma Concentration (Cmax): Part 2||0 (pre-dose), 1, 6, 24, 48, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.||ng/mL||Standard Deviation|Mean
172500|NCT00106353|Secondary|Number of Participants With Potentially Clinically Important (PCI) Values by National Cancer Institute Common Terminology Criteria (NCI-CTC) Grade for Laboratory Values: Part 2|Number of participants who met the PCI criteria (grades 1 through 5) for laboratory values (hematology and serum chemistry). NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided with grades ranging from 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening or disabling), to 5 (death). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172501|NCT00106353|Secondary|Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 2|Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees C, respiratory rate >20 bpm, and systolic and diastolic BP >200/110 mmHg. Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172502|NCT00106353|Primary|Number of Participants With Potentially Clinically Important (PCI) Changes in Vital Signs: Part 1|Number of participants who met the criteria for PCI changes (based on baseline values before treatment); criteria defined as body temperature >39 degrees Celsius (C), respiratory rate >20 beats per minute (bpm), and systolic and diastolic blood pressure (BP) >200/110 millimeters of mercury (mmHg). Participants may be reported in more than 1 category.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172503|NCT00106353|Primary|Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 1|Dose reduction for individual participant allowed if a dose limiting toxicity (DLT) occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172504|NCT00106353|Primary|Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 1|Temporary interruption of study treatment; may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172505|NCT00106353|Primary|Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 1|SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability / incapacity or are a congenital anomaly or birth defect in the offspring of a study subject. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172506|NCT00106353|Primary|Number of Participants Who Died: Part 1|Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172507|NCT00106353|Primary|Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 1|TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period. National Cancer Institute (NCI)-graded Common Toxicity Criteria (CTC) provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172508|NCT00106353|Primary|Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 1|TEAEs are events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. AEs that occurred within 30 days of the last administration of study treatment can be attributed to the treatment period.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172509|NCT00106353|Secondary|Number of Participants With Adverse Events Causing Dose Reduction of Study Treatment: Part 2|Dose reduction for individual participant allowed if a DLT occurred; may continue treatment following reduction by 1 to 2 dose levels (determined by investigator and medical monitor). DLT= failure to recover to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of >3 weeks) unless investigator and medical monitor agree participant should remain in the study.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172510|NCT00106353|Secondary|Number of Participants With Adverse Events Causing Temporary Stop of Study Treatment: Part 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Temporary interruption of study treatment may be followed by resumption of study treatment at current dose or dose modification as determined by the investigator and medical monitor.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172511|NCT00106353|Secondary|Number of Participants With Drug Related Serious Adverse Events (SAEs): Part 2|An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Participants with documented study treatment toxicity were followed weekly until recovering. After the 30 day reporting period, only SAEs believed to be related to study treatment were to be reported.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172512|NCT00106353|Secondary|Number of Participants Who Died: Part 2|Deaths were reported from baseline throughout the 30 day period after last study treatment. After the 30 day reporting period, only deaths believed related to study treatment were to be reported (as SAEs).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172513|NCT00106353|Secondary|Number of Participants With Drug Related Grade 3 and Higher Treatment Emergent Adverse Events (TEAEs): Part 2|Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. NCI-CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172514|NCT00106353|Secondary|Number of Participants With Drug Related Treatment Emergent Adverse Events (TEAEs): Part 2|Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172515|NCT00106353|Secondary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 2|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to EOT (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172566|NCT00106028|Secondary|Incidence New Vertebral Fractures by SQ (Semi-Quantitative) Score, Patients Aged 4-9 Years, Month 12, ITT Population|Patients aged 4-9 years with new morphometric vertebral fractures as measured by SQ analysis of x-rays using the Genant scoring system at Month 12 +/- 14 days. (Ref: Genant 1993). SQ Score mild - 0/no fracture to Grade 1, Moderate to Severe - change from 0/no fracture to Grade 2-3.|Month 12|ITT Population, Number of Participants Analyzed = Number of participants with baseline and Month 12 data||Participants|||Number
172516|NCT00106353|Secondary|Percentage of Participants Exhibiting Freedom From Progression at Week 12: Part 2|Freedom from progression measured as Stable Disease (SD) or better and no Progressive Disease (PD); (CR+VGPR+Mixed Response [MR]+PR+SD). CR=disappearance of all primary and metastatic lesions. VGPR=disappearance of all metastatic lesions. MR=no new lesions; at least 50% decrease in any 1 disease measurement with <50% decrease in any other disease measurement or an increase of <25% in any lesion). SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=at least a 25% increase in any disease measurement; or the appearance of 1 or more new lesions.|Week 12|Efficacy evaluable population included all participants who received at least 3 doses of study treatment. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||percentage of participants||95% Confidence Interval|Number
172517|NCT00106353|Secondary|Percentage of Participants With Best Overall Response: Part 1|Best overall response is the best response recorded from baseline until disease progression or recurrence. Measured as CR, PR, SD, PD, or Unknown. CR=disappearance of all primary and metastatic lesions. PR=at least a 50% decrease in primary disease measurement. SD=no new lesions; decrease of <50% in all lesions with no lesion increasing >25%. PD=any new lesion; at least a 25% increase in any disease measurement (reference smallest disease measurement recorded since start of treatment); or appearance of 1 or more new lesions. Tumor response considered Unknown if assessment prior to Day 37.|Baseline until disease progression or recurrence (actual greatest response day is up to Day 49)|Efficacy evaluable population included all participants who received at least 3 doses of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively.||percentage of participants|||Number
172518|NCT00106353|Secondary|Volume of Distribution at Steady State (Vss): Part 1|Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||Liter||Standard Deviation|Mean
172519|NCT00106353|Secondary|Clearance (CL): Part 1|CL is a quantitative measure of the rate at which a drug substance is removed from the body.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||Liter/hr||Standard Deviation|Mean
172520|NCT00106353|Secondary|Area Under the Concentration-Time Curve (AUC): Part 1|AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||hr*ng/mL||Standard Deviation|Mean
172521|NCT00106353|Secondary|Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]: Part 1|AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||hr*ng/mL||Standard Deviation|Mean
172522|NCT00106353|Secondary|Plasma Decay Half-Life (t1/2): Part 1|Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.|0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, the 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure for each group respectively. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||hr||Standard Deviation|Mean
172523|NCT00106353|Secondary|Time to Reach Maximum Observed Plasma Concentration (Tmax): Part 1||0 (pre-dose), 1, 2, 6, 24, and 168 hrs post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||hr||Standard Deviation|Mean
172524|NCT00106353|Secondary|Maximum Observed Plasma Concentration (Cmax): Part 1||0 (pre-dose), 1, 2, 6, 24, and 168 hours (hrs) post-dose of Cycle 1 and 0 (pre-dose), 1, 2, 6, 24, 72, 96, and 168 hrs post-dose of Cycle 2 (cycles are approximately 21 days)|Safety population included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable for particular cycle for each group respectively.||nanogram per milliliter (ng/mL)||Standard Deviation|Mean
172525|NCT00106353|Secondary|Number of Participants Who Reached Maximum Tolerated Dose Due to Dose Limiting Toxicity: Part 1|Maximum tolerated dose (MTD) defined as the dose level at which >=2 of 3 participants or >=2 of 6 participants if the dose level had been expanded, experienced a dose limiting toxicity (DLT) by day 21 after the first dose of study treatment. DLT defined as failure to recover to NCI-CTCAE version 3.0 grade 0 to 2 (or within 1 grade of starting values for pre-existing laboratory abnormalities) from a treatment-related toxicity within 3 weeks (leading to a treatment delay of > 3 weeks) unless the investigator and the medical monitor agree that the subject should remain in the study.|Baseline up to Month 6|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172526|NCT00106353|Primary|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs): Part 1|An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Baseline up to End of Treatment (EOT) (within 30 days of last dose)|Safety population included all participants who received at least 1 dose of study medication.||participants|||Number
172527|NCT00106249|Secondary|Motor Cortex Excitability (Short Intracortical Inhibition)|In 22 OCD patients enrolled in the RCT, we applied the new customized software for acquisition and analysis of neurophysiology data that was developed to allow for automatic control of the TMS devices during motor cortex excitability measures. For the paired-pulse (PP) measurements of short intracortical inhibition (SICI) the interstimulus interval (ISI) was set to 8-12 seconds on a continuous uniform distribution. The FPGA board samples the EMG data, controls the timing of the TMS stimuli, and also controls the intensity of the devices.|Through study completion|Independent sample t-test, right hemisphere SICI||% change in conditioned/control MEP||Full Range|Mean
172528|NCT00106249|Secondary|Motor Cortex Excitability (Motor Threshold)|In 22 OCD patients, who completed the RCT, we applied the new customized software for acquisition and analysis of neurophysiology data that was developed to allow for automatic control of the TMS devices during motor cortex excitability measures. Specifically, the software delivers TMS pulses and automatically determines motor threshold (MT); a descending staircase method is utilized, starting at the intensity at which the optimal site selection for the MT is determined. After each stimulus in the MT experiments, the software would prompt the user to confirm the automated MEP-detection.|Through study completion|repeated measure ANOVA, time X group interaction, right hemisphere MT||% MT change on right hemisphere||Full Range|Mean
172529|NCT00106249|Primary|Clinical Improvement (Yale-Brown Obsessive Compulsive Scale/Y-BOCS)|Response rate was defined as a decrease >25% on the YBOCS-SR. Y-BOCS-Self Report (Baer et al. 1993) is very similar to the clinician-administered one, and has shown excellent internal consistency and test-retest reliability, performing somewhat better than the interview (Steketee et al., 1996); subjects are asked to focus on the main obsessions and main compulsions and to answer five questions: time spent, interference, distress, resistance, and control. Consistent with the interview format, subjects rate each item on a 0 (none) to 4 (extreme) scale.|Through study completion|||percentage of participants|||Number
172530|NCT00106184|Secondary|20% Improvement in Manual Muscle Testing (MMT) Over Baseline on Two Consecutive Time Points (Muscle is the Primary Organ of Involvement, and MMT is the One Objective Measurement of the Definition of Improvement [DOI])|Number of participants with a 20% improvement in MMT over baseline on two consecutive time points.|Week 44 of treatment phase|Intention to Treat (ITT)||Participants|||Number
172531|NCT00106184|Secondary|Response Rates (Proportion of Improved Patients) Between Groups A (Rituximab Wks 0 and 1) and B (Rituximab Wks 8 and 9) at Week 8|"The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by ≥ 20%, with no more than 2 of the core set measures worsening by ≥25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures.~Core Set Measures Included:~Manual Muscle Testing (MMT)- Muscle Strength~Physician Global Disease Activity VAS Score~Health Assessment Questionnaire Index Score - Physical Function~Patient Global Assessment of Disease Activity VAS score~Extramuscular Activity - Myositis Disease Activity Assessment Tool~2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH)"|Week 8 of the treatment phase|Intention to Treat (ITT)||participants|||Number
172532|NCT00106184|Primary|Comparison Between the Time to Improvement Between the Two Groups of IIM (Idiopathic Inflammatory Myopathy) Patients|"The Definition of Improvement for both adult and pediatric patients will be: 3 of any of the 6 core set measures improved by ≥ 20%, with no more than 2 of the core set measures worsening by ≥25% (worsening measure cannot include the MMT) at two consecutive visits. Of note, the MMT could not be one of the worsening measures.~Core Set Measures Included:~Manual Muscle Testing (MMT)- Muscle Strength~Physician Global Disease Activity VAS Score~Health Assessment Questionnaire Index Score - Physical Function~Patient Global Assessment of Disease Activity VAS score~Extramuscular Activity - Myositis Disease Activity Assessment Tool~2 or more elevated muscle enzymes (Aldolase, CK, AST, ALT, and LDH)"|Week 44 of treatment phase|Intention to Treat (ITT)||Weeks||Full Range|Median
172533|NCT00106119|Secondary|Apolipoprotein B at Liothyronine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
172534|NCT00106119|Secondary|Apolipoprotein B at Levothyroxine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
172535|NCT00106119|Secondary|Apolipoprotein A-I at Liothyronine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
172536|NCT00106119|Secondary|Apolipoprotein A-I at Levothyroxine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
172537|NCT00106119|Secondary|Left Ventricle Mass Index at Liothyronine Treatment Phase||One month of therapy.|||g/m^2||Standard Deviation|Mean
172538|NCT00106119|Secondary|Left Ventricle Mass Index at Levothyroxine Treatment Phase||One month of therapy.|||g/m^2||Standard Deviation|Mean
172539|NCT00106119|Secondary|Resting Energy Expenditure at Liothyronine Treatment Phase||One month of therapy.|||kcal/24 hour||Standard Deviation|Mean
172540|NCT00106119|Secondary|Resting Energy Expenditure at Levothyroxine Treatment Phase||One month of therapy.|||kcal/24 hour||Standard Deviation|Mean
172541|NCT00106119|Secondary|Triglycerides at Liothyronine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
172542|NCT00106119|Secondary|Triglycerides at Levothyroxine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
172543|NCT00106119|Secondary|Total Cholesterol at Liothyronine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
172544|NCT00106119|Primary|Insulin-mediated Glucose Disposal Rate at Liothyronine Treatment Phase||One month of therapy|||mg/kg/min||Standard Deviation|Mean
172545|NCT00106119|Secondary|Total Cholesterol at Levothyroxine Treatment Phase||One month of therapy.|||mg/dl||Standard Deviation|Mean
172546|NCT00106119|Primary|Insulin-mediated Glucose Disposal Rate at Levothyroxine Treatment Phase||One month of therapy.|||mg/kg/min||Standard Deviation|Mean
172547|NCT00106106|Primary|Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 25|The ratio of glutamate to creatine was determined using magnetic resonance spectroscopy (MRS), a technique that complements magnetic resonance imaging (MRI). MRS is used to determine the concentration of brain metabolites, such as glutamate, in brain tissue. MRS utilizes a magnetic field to look at magnetic nuclei, which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra the structure and concentration of metabolites can be determined.|Day 25|||Ratio of glutamate to creatine||Standard Error|Mean
172548|NCT00106106|Primary|Ratio of Glutamate to Creatine in the Anterior Cingulate of the Brain, Measured on Day 4|The ratio of glutamate to creatine was determined using magnetic resonance spectroscopy (MRS), a technique that complements magnetic resonance imaging (MRI). MRS is used to determine the concentration of brain metabolites, such as glutamate, in brain tissue. MRS utilizes a magnetic field to look at magnetic nuclei, which absorb and re-emit electromagnetic energy in the presence of the magnetic field. By looking at the peaks in the resultant spectra the structure and concentration of metabolites can be determined.|Day 4|The analysis of participants was per protocol, i.e., all subjects who completed two MRS scans(Day 4 and Day 25) and for whom there were two measures of the glutamate/creatine ratio||Ratio of glutamate to creatine||Standard Error|Mean
172549|NCT00106080|Secondary|Effect of Intervention on Patient Reported Discussions About Treatment Preferences at Their Last Clinic Visit.|We measured the difference between intervention and control group patients reporting having had a discussion with their clinician about treatment preferences at their last clinic visit.|Assessed 2 weeks after targeted clinic visit|||Proportion of participants reporting||95% Confidence Interval|Number
172550|NCT00106080|Primary|Effect of Intervention on Quality of Patient Clinician Communication About End-of-Life Care(QOC) Scale|The quality of end-of-life communication (QOC) score ranges between 0 and 100, with higher scores indicating better communication between patients and providers.|Measured at enrollment and 2 weeks after targeted clinic visit|||units on a scale||95% Confidence Interval|Mean
172551|NCT00106028|Secondary|Annualized Growth Velocity - Change From Baseline to Month 36, ITT Population|Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]|Baseline and Month 36|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data||Change in Annualized Growth Velocity||95% Confidence Interval|Least Squares Mean
172552|NCT00106028|Secondary|Annualized Growth Velocity - Change From Baseline to Month 12, ITT Population|Annualized Growth Velocity [= bone age change from baseline x (365.25/time in days between baseline and the bone age measurement)]|Baseline and Month 12|ITT Population, Number of Participants Analyzed = Number of participants at baseline and Month 12 data||Change in Annualized Growth Velocity||95% Confidence Interval|Least Squares Mean
172553|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 36, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 36|ITT Population||Years||95% Confidence Interval|Least Squares Mean
172554|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 24, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 24|ITT Population||Years||95% Confidence Interval|Least Squares Mean
172555|NCT00106028|Secondary|Bone Age (Years), Change From Baseline to Month 12, ITT Population|Bone Age determined by visual assessment of hand / wrist radiographs.|Baseline and Month 12|ITT Population||Years||95% Confidence Interval|Least Squares Mean
172556|NCT00106028|Secondary|Wong-Baker FACES Pain Rating Scale - Change From Baseline to Month 12, ITT Population|Wong-Baker FACES Pain Rating Scale (pain assessment scale using facial expressions, translated into a range from 0= no pain [smiling face] to 10= worst pain possible [distorted face with tears]; negative values indicate decrease in pain). Reference: Wong DL et al.|Baseline and Month 12|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
172557|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 36, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172558|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 24, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172559|NCT00106028|Secondary|Urine NTX/Cr - Percent Change From Baseline at Month 12, ITT Population|Urine type-I collagen N-telopeptide/creatinine (NTX/Cr; bone resorption marker). Negative percent changes indicate response to treatment.|Baseline and Endpoint / Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172560|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 36, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 36 Months|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172561|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 24, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 24 Months|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172562|NCT00106028|Secondary|Serum BAP - Percent Change From Baseline to Month 12, ITT Population|Serum Bone Alkaline Phosphatase (BAP - bone formation marker). Negative percent changes indicate response to treatment.|Baseline and 12 Months|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172563|NCT00106028|Secondary|Number of Clinical Fractures, Month 12, ITT Population|Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.|12 Months|ITT Population||Participants|||Number
172564|NCT00106028|Secondary|Probability of Fracture in 12 Months (Kaplan-Meier Cumulative Incidence), ITT Population|Long bones include radius, ulna, humerus, tibia, fibula, femur, upper limb and lower limb fracture.|Time to First Event (days) up to 12 Months|ITT Population||Probability of Fractures|||Number
172567|NCT00106028|Secondary|Categorization by Number of New Morphometric Vertebral Fracture at Month 36, ITT|Patients with 1 or more New Morphometric Vertebral Fracture as measured by SQ analysis of x-rays using the Genant scoring system (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). Incidence = SQ score is 0 at baseline and >0 at post-baseline.|Baseline and Month 36|ITT Population||Participants|||Number
172570|NCT00106028|Secondary|New Morphometric Vertebral Fracture at Month 12, ITT Population|Morphometric Vertebral Fracture measured by semi-quantitative (SQ) analysis of x-rays using the Genant scoring system at endpoint. (Ref: Genant 1993). SQ-Scores range from 0 (no fracture) to 3 (severe fracture). New fracture = SQ score is 0 at baseline and >0 at the specified end visit.|Baseline and Month 12|ITT Population||Participants|||Number
172571|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 36, ITT Population||Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172572|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 24, ITT Population||Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172573|NCT00106028|Secondary|Percent Change From Baseline in Total Body Bone Area Month 12, ITT Population||Baseline and Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172574|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 36, ITT Population|Measured by DXA.|Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172575|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 24, ITT Population|Measured by DXA.|Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172576|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine Bone Area at Month 12, ITT Population|Measured by DXA.|Baseline and Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172577|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 36, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 36|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
172578|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 24, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 24|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
172579|NCT00106028|Secondary|Total Body Z-score- Percent Change From Baseline to Month 12, ITT Population|"Total Body Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 12|ITT Population, Population Description Number of Participants Analyzed = Number of participants at baseline and LOCF data||Units on a Scale||95% Confidence Interval|Least Squares Mean
172580|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 36, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 36|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
172581|NCT00106028|Primary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 12, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader. Duplicate scans obtained at screening and Month 12.|Baseline and Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172582|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 24, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 24|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
172583|NCT00106028|Secondary|Lumbar Spine Z-score - Percent Change From Baseline to Month 12, ITT Population|"Lumbar Spine Z-score - number of standard deviations a patient's BMD differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are best values and negative values are worst values."|Baseline and Month 12|ITT Population||Units on a Scale||95% Confidence Interval|Least Squares Mean
172584|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 36, ITT Population||Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172585|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 24, ITT Population||Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172586|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMC at Month 12, ITT Population||Baseline and Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172587|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 36, ITT Population||Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172588|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 24, ITT Population||Baseline and Month 24|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172589|NCT00106028|Secondary|Percent Change From Baseline in Lumbar Spine BMC (Bone Mineral Content) at Month 12, ITT Population||Baseline and Month 12|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172590|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 36, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 36|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
172591|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 24, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 24|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
172592|NCT00106028|Secondary|Percent Change From Baseline in Total Body BMD at Month 12, ITT Population|Percent Change from baseline in Total Body Bone Mineral Density (BMD) measured by DXA.|Baseline and Month 12|ITT Population.||Percent Change||95% Confidence Interval|Least Squares Mean
172593|NCT00106028|Secondary|Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Month 36, ITT Population|Lumbar Spine Bone Mineral Density (BMD) measured by dual-energy x-ray absorptiometry (DXA)and read by central reader.|Baseline and Month 36|ITT Population||Percent Change||95% Confidence Interval|Least Squares Mean
172595|NCT00106002|Secondary|Overall Survival Time|Defined as the time from date of first dose to time of death due to any cause.|every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up|Intent to treat population (in order to follow protocol, one patient who did not take any study drug was excluded from this analysis)||months||Full Range|Median
172596|NCT00106002|Secondary|Progression-Free Survival Time|Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression|Intent to treat population (in order to follow protocol, one patient who did not take study drug was excluded from this analysis)||months||Full Range|Median
172597|NCT00106002|Secondary|Duration of Tumor Response|Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression|Only applies to patients who had a complete or partial response||months||Full Range|Median
172598|NCT00106002|Secondary|Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)|Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).|every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up|||participants|||Number
172599|NCT00106002|Primary|Overall Tumor Response|"Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve (respond), stay the same (stable), or worsen (progression) during treatment."|every 3 cycles (approximately 6-7 weeks) or until patient has disease progression|||participants|||Number
172600|NCT00105989|Secondary|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase||Every Visit from Week 10 up to Week 34 (Continuation)|Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.||participants|||Number
172601|NCT00105989|Secondary|Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase||Every Visit from Week 0 up to Week 10 (Acute)|Treatment-Emergent Adverse Events (TEAE) occurring in at least 5% of patients. Intent to Treat analysis.||participants|||Number
172602|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
172603|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
172604|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Units per Liter||Standard Deviation|Mean
172605|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||grams per Liter||Standard Deviation|Mean
172606|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Giga per Liter||Standard Deviation|Mean
172607|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||femtoliters||Standard Deviation|Mean
172608|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
172609|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
172610|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Giga per Liter||Standard Deviation|Mean
172611|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
172612|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Actual count||Standard Deviation|Mean
172613|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Units per Liter||Standard Deviation|Mean
176537|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 2||Baseline to Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
172614|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Tera per Liter||Standard Deviation|Mean
172615|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
172616|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||micromoles per Liter||Standard Deviation|Mean
172617|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||micromoles per Liter||Standard Deviation|Mean
172618|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
172619|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase||Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||grams per Liter||Standard Deviation|Mean
172620|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||micromoles per Liter||Standard Deviation|Mean
172621|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||grams per Liter||Standard Deviation|Mean
172622|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
172623|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Giga per Liter||Standard Deviation|Mean
172624|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
172625|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||actual count||Standard Deviation|Mean
172626|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Units per Liter||Standard Deviation|Mean
172627|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||Giga per Liter||Standard Deviation|Mean
172628|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
172629|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||millimoles per Liter||Standard Deviation|Mean
172630|NCT00105989|Secondary|Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase||Week 0 and Week 10|Number of patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||grams per Liter||Standard Deviation|Mean
172631|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||mm Hg||Standard Error|Least Squares Mean
172632|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||mm Hg||Standard Deviation|Mean
172633|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase||Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||beats per minute||Standard Error|Least Squares Mean
172634|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||beats per minute||Standard Deviation|Mean
172636|NCT00105989|Secondary|Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases||Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||kilograms||Standard Deviation|Mean
172637|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|N=Number of female randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Female patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
172638|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|N=Number of male randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Male patients who have been sexually active in the previous month respond to Items 3-5. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
172639|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of female enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of female patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
172640|NCT00105989|Secondary|Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)|A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of male enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of male patients who entered Continuation Phase with a baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
172641|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients who work for pay and missed work due to illness. Intent to Treat analysis.||hours||Standard Error|Least Squares Mean
172642|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase who work for pay and missed work due to illness. Number of patients who entered the Continuation Phase who work for pay and missed work due to illness. Intent to Treat analysis.||hours||Standard Deviation|Mean
172643|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients who work for pay. Intent to Treat analysis.||hours||Standard Error|Least Squares Mean
172644|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase who work for pay. Number of patients who entered the Continuation Phase who work for pay. Intent to Treat analysis.||hours||Standard Deviation|Mean
172645|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 34 through Week 86 (Maintenance Phase)|Number of randomized patients who indicated they had visits to specified health care provider. Intent to Treat analysis.||visits||Standard Error|Least Squares Mean
172694|NCT00105196|Secondary|Mean Change in SDS Item Score (Work/School)|Mean change from Week 8 (baseline) to Week 14 in SDS Work/School Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14|||units on a scale||Standard Error|Mean
172646|NCT00105989|Secondary|Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases|Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.|Week 0 through Week10 (Acute) through Week 34 (Continuation)|"Number of enrolled patients in Acute Phase and number who entered Continuation Phase who indicated they had visits to specified health care provider. Intent to Treat analysis. Note: Other Mental Health Care Worker wasn't included in table (1 patient in Acute). Other Health Care Worker wasn’t included in table (2 patients in Continuation)."||visits||Standard Deviation|Mean
172647|NCT00105989|Secondary|Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase|Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
172648|NCT00105989|Secondary|Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase|Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
172649|NCT00105989|Secondary|Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
172650|NCT00105989|Secondary|Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases|The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
172651|NCT00105989|Secondary|Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase|The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with non-missing baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
172652|NCT00105989|Secondary|Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases|The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
172653|NCT00105989|Secondary|Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline value. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
172654|NCT00105989|Secondary|Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase|VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
172655|NCT00105989|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase|Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood item (0-4).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
177806|NCT00006178|Primary|Serum Creatinine Concentration|measures at 6 months after intervention|6 months after intervention|Analysis includes all participants in the study. Analysis was per protocol.||umol/L||Standard Deviation|Mean
172656|NCT00105989|Secondary|Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases|Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Depressed Mood Item (0-4).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
172657|NCT00105989|Secondary|Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 86 (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
172658|NCT00105989|Secondary|Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases|A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).|Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
172659|NCT00105989|Secondary|Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline assessment. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
172660|NCT00105989|Secondary|Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases|Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
172661|NCT00105989|Secondary|Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)|Number of randomized patients with a baseline and at least one non-missing post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Error|Least Squares Mean
172662|NCT00105989|Secondary|Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases|The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).|Week 0 and Week 10 (Acute) and Week 34 (Continuation)|Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.||units on a scale||Standard Deviation|Mean
172663|NCT00105989|Secondary|Loss of Response at Any Time|Loss of response was defined as a HAMD-17 total score >9 and a CGI-Severity score >2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not.|Every Visit from Week 35 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing post-baseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.||participants|||Number
172664|NCT00105989|Secondary|Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days|Worsening occurs if patient had a >=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score >=3 at any time during the double-blind maintenance therapy phase.|Every Visit from Week 34 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing post-baseline assessment during the double blind maintenance therapy phase. Intent to Treat analysis.||percentage of participants|||Number
172665|NCT00105989|Secondary|Recurrence Count|Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase.|Every Visit from Week 35 up to Week 86 (Maintenance Phase)|Number of randomized patients with at least one non-missing postbaseline assessment during the double-blind maintenance therapy phase. Intent to Treat analysis.||participants|||Number
172666|NCT00105989|Primary|Percentage of Participants With Depressive Recurrence After Time (t) in Days|Recurrence: Clinical Global Impression-Severity (CGI-S) score >=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.|Every Visit from Week 34 up to Week 86 (Maintenance Phase)|All randomized patients. Intent to Treat analysis.||percentage of participants|||Number
172667|NCT00105534|Secondary|Participants Who Achieved Bacteriological Eradication|Bacterial eradication is defined as the eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).|Visit 3 (Day 6-7)|Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.||Participants|||Number
172668|NCT00105534|Primary|Participants Who Achieved Clinical Resolution|Clinical Resolution is defined as absence of all three clinical signs: ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection.|Visit 3 (Days 6-7)|Per protocol population (defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment) with last observation carried forward.||Participants|||Number
172669|NCT00105482|Secondary|Cigarettes Smoked Per Day.|Average number of cigarettes smoked per day at 26 weeks.|26 weeks|Patients were analyzed per protocol.||number of cigarettes||Standard Deviation|Mean
172670|NCT00105482|Secondary|Point Prevalence Smoking Abstinence at 6 Weeks|The number of people that were abstinent from cigarette smoking at 6 weeks.|6 weeks|All patients who were randomized comprised the primary ITT population.||participants|||Number
172671|NCT00105482|Secondary|Weight Gain at 6 Weeks.|Weight change from baseline measured at 6 weeks.|6 weeks|All patients who were randomized comprised the primary ITT population.||pounds||Standard Deviation|Mean
172672|NCT00105482|Primary|Point Prevalence Smoking Abstinence at 26 Weeks.|The number of people that were abstinent from cigarette smoking at 26 weeks.|26 weeks|All patients who were randomized comprised the primary ITT population.||participants|||Number
172673|NCT00105482|Primary|Weight Gain at 26 Weeks.|Weight change from baseline measured at 26 weeks.|26 weeks|All patients who were randomized comprised the primary ITT population.||pounds||Standard Deviation|Mean
172674|NCT00105469|Secondary|Number of Participants Who Achieved Bacterial Eradication at Visit 3|Bacterial eradication is defined as eradication of the causative pathogens as indicated by the absence of growth (0 colony forming units/mL) of the original infecting organism(s).|Visit 3 (Day 6)|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."||Participants|||Number
172675|NCT00105469|Primary|Number of Participants Who Achieved Clinical Resolution at Visit 3|Clinical resolution is defined as absence of all three clinical signs (ocular discharge, bulbar conjunctival injection, and palpebral conjunctival injection).|Visit 3 (Day 6)|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."||Participants|||Number
172676|NCT00105443|Post-Hoc|Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire|PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value. At the cut-off date for this analysis, one more patient data has been gained.|from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment|In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 Day 1 or, for those discontinuing prior to that visit, at the end of study. It was summarized as number of patients with change from baseline <8 to ≥8 points for each treatment group up to the cutoff date of 09 Feb 2007.||Participants|||Number
172677|NCT00105443|Post-Hoc|Disease Control (DC)|The DC is defined as the number of subjects with a best response rating of CR, PR, or SD that is maintained at least 28 days from the first manifestation of that rating.|from randomization to end of treatment up to the data cutoff date approximately 23 months after start of enrollment|The disease control rate for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors (RECIST) up to the cutoff date of 09 Feb 2007||Participants|||Number
172678|NCT00105443|Post-Hoc|Time to Progression (TTP)|TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 23 months after start of enrollment|The independent radiological review as initially scheduled for the interim analysis did not continue after 12 May 2006. The primary analysis of TTP for the ITT population after 12 May 2006 up to the cutoff date of 09 Feb 2007 was based on the Investigator radiological assessments||Days||95% Confidence Interval|Median
172679|NCT00105443|Post-Hoc|Time to Symptomatic Progression (TTSP)|TTSP was defined as the time from randomization to the first documented symptomatic progression|from randomization to the first documented symptomatic progression until an average 5.7 months later up to the data cut-off date approximately 23 months after start of enrollment|For subjects (in the ITT population) who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of last FACT FHSI-8 questionnaire assessment (upon an interim review by the Data Monitoring Committee on 09 Feb 2007), when the study was considered positive for its primary endpoint, OS, and was stopped early.||Days||95% Confidence Interval|Median
172680|NCT00105443|Post-Hoc|Overall Survival|Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|from randomization to death due to any cause until an average 8.5 months later up to the data cut-off date approximately 23 months after start of enrollment|The OS data (ITT population) are descriptive only (no p-values) from the date of randomization to the date of death due to any cause. For patients alive at the time of analysis, time to death was censored at the date of last follow-up or at the data cutoff date of 09 Feb 2007 when subjects were given the option to crossover to sorafenib treatment||Days||95% Confidence Interval|Median
172695|NCT00105196|Secondary|Mean Change in SDS Item Score (Family Life)|Mean change from Week 8 (Baseline) to Week 14 in SDS Family Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14|||units on a scale||Standard Error|Mean
172681|NCT00105443|Secondary|Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire|PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.|from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment|In this study, the PRO was a tertiary efficacy variable assessed for the ITT population at Cycle 3 day 1 or, for those discontinuing prior to that visit, at end of study. It was summarized as number of patients with change from baseline <8 or ≥8 points for each treatment group up to the cutoff date of 17 Oct 2006||Participants|||Number
172682|NCT00105443|Secondary|Disease Control (DC)|The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.|time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment|In this study, the DC for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors [RECIST])||Participants|||Number
172683|NCT00105443|Secondary|Time to Progression (TTP)|TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.|from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment|The primary analysis of TTP for the ITT population was based on the independent radiological review for the interim analysis. The cut-off date chosen for the analysis of radiological progression events was 12 May 2006||days||95% Confidence Interval|Median
172684|NCT00105443|Primary|Time to Symptomatic Progression (TTSP)|TTSP was defined as the time from randomization to the first documented symptomatic progression.|from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment|This analysis was for the ITT population. For subjects who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of their last Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) questionnaire assessment.||days||95% Confidence Interval|Median
172685|NCT00105443|Primary|Overall Survival (OS)|Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.|from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment|In this study the overall survival was measured for the ITT population from the date of randomization until the date of death due to any cause. For patients alive or lost to follow-up at the time of analysis, time to death was to be censored at their last date of follow-up, or at the data cut-off of 17 Oct 2006.||days||95% Confidence Interval|Median
172686|NCT00105235|Secondary|Proportion of Participants Successfully Withdrawn and Remain Off Immunosuppressants|This measure of tolerance induction includes the proportion of participants who qualify for immunosuppression withdrawal as determined by a review of individual clinical results by a protocol withdrawal committee, were successfully withdrawn from immunosuppressants, and remained off immunosuppressants at the time the trial ended. Successful withdrawal definition: participants who remain off immunosuppression for at least 8 weeks and do not restart immunosuppressant drugs after successful withdrawal.|From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant)|Intent-to-treat||Proportion of Participants|||Number
172687|NCT00105235|Secondary|Proportion of Participants Successfully Withdrawn From Immunosuppressants|This measure of tolerance induction includes the proportion of participants who qualify for immunosuppression withdrawal as determined by a review of individual clinical results by a protocol withdrawal committee. Successful withdrawal definition: participants who remain off immunosuppression for at least 8 weeks.|From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant)|Intent-to-treat||Proportion of Participants|||Number
172688|NCT00105235|Secondary|Number of Events: Immunosuppression-related Complications|Certain events are associated with immunosuppression. This measure looks at post-transplant infection, post-transplant malignancies, post-transplant diabetes, and post-transplant renal failure. Immunosuppression withdrawal is intended to reduce these type of events. However, reduction in immunosuppression can lead to complications in liver and renal function, as measured by acute rejection, chronic rejection, and post-transplant renal failure. Lower numbers for any of these events indicates greater success with transplantation and immunosuppression withdrawal (where applicable)|From transplantation until study completion or participant termination (participants followed up to 60 months)|Safety Sample||Events|||Number
172689|NCT00105235|Secondary|Proportion of Participants Who Had Graft Loss or Death|Proportion of participants who had liver graft loss or who died or terminated from the study within 2 years of initiating immunosuppression withdrawal|Within 2 years after initiation of immunosuppression withdrawal|Participants who initiated immunosuppression withdrawal||Proportion of Participants|||Number
172690|NCT00105235|Primary|Proportion of Participants Who Have Graft Loss or Death|Proportion of participants who had liver graft loss or who died within 1 year of undergoing transplantation. Note: Participants who discontinued treatment or terminated the study prior to 1 year post transplantation are considered treatment failures and are included in this measure.|Within 1 year of post-transplantation|Safety Sample||Proportion of Participants|||Number
172691|NCT00105196|Other Pre-specified|MADRS Remission|Number of subjects in remission. Remission defined as as MADRS Total Score of <10 at 14 weeks, and a reduction of ≥50 percent from Week 8 (baseline) in MADRS, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms).|Baseline (Week 8) and Week 14|||participants|||Number
176591|NCT00053703|Secondary|Change From Baseline in Weight at Week 8|change in weight from baseline to week 8 in kg|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.||Kg||Standard Deviation|Mean
172696|NCT00105196|Secondary|Mean Change in SDS Item Score (Social Life)|Mean change from Week 8 (baseline) to Week 14 in SDS Social Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14|||units on a scale||Standard Error|Mean
172697|NCT00105196|Secondary|Mean Change in Sheehan Disability Scale (SDS) Mean Score|Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14|||units on a scale||Standard Error|Mean
172698|NCT00105196|Primary|Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)|Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score – baseline score. A negative change score indicates improvement.|Baseline (Week 8) and Week 14|||units on a scale||Standard Error|Mean
172699|NCT00105183|Secondary|Pulmonary Function Test, Forced Expiratory Flow 25-75||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit||Liters/second||Full Range|Median
172700|NCT00105183|Secondary|Pulmonary Function Test, Forced Expiratory Volume in 1 Second||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit||Liters||Full Range|Median
172701|NCT00105183|Secondary|Pulmonary Function Test, Forced Vital Capacity||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit||Liters||Full Range|Median
172702|NCT00105183|Secondary|Pulmonary Function Tests, Total Distance Walked 6 Minute Walk Test||12 months|Pulmonary Function Tests (PFTs) are reported for all participants of the ITT population, who were alive at 12 months after transplantation and for whom PFT results were reported for the 12-month visit||Meters||Full Range|Median
172703|NCT00105183|Secondary|Number of Participants With Severe Adverse Events||12 months|Safety population||participants|||Number
172704|NCT00105183|Secondary|Number of Participants With Infections and Infestations||12 months|Safety population||participants|||Number
172705|NCT00105183|Secondary|Number of Participants With Acute Rejection||12 months|ITT||participants|||Number
172706|NCT00105183|Secondary|Number of Participants With Death or Graft Loss Post-transplant||12 months|ITT population||participants|||Number
172707|NCT00105183|Primary|Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First)||12 months|ITT. During the interim analysis the 5 mg/kg arm was dropped and it was showed that the study was insufficiently powered so the main focus of study shifted to safety endpoints. Data is based on local lung biopsy readings for efficacy failure instead of central readings||participants|||Number
172708|NCT00105157|Secondary|Number of Patients Discontinued With LAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172709|NCT00105157|Secondary|Number of Patients With Serious Drug-related LAEs at 168 Weeks|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172710|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 168 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172711|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172712|NCT00105157|Secondary|Number of Patients With Serious LAEs at 168 Weeks|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172713|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172714|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172715|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172716|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks||168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
177548|NCT00025233|Secondary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Every other 3-week treatment cycle|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
172719|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 168 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172720|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 168 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172721|NCT00105157|Secondary|Number of Patients With Serious CAEs at 168 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172722|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|168 weeks|All patients who took study medication were included in the analysis (All Patients as Treated approach). Data include patients from the double-blind plus open-label phases.||Participants|||Number
172723|NCT00105157|Other Pre-specified|Change From Baseline in CD4 Cell Count at Week 168 in Combined Substudies|Mean change from baseline at Week 168 in CD4 Cell Count (cells/mm3) in patients from combined substudies in the double-blind plus open-label phases.|Baseline and Week 168|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
172724|NCT00105157|Other Pre-specified|Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 168 in Combined Substudies|Mean change from baseline at Week 168 in HIV RNA (log10 copies/mL) in patients from combined substudies in the double-blind plus open-label phases.|Baseline and Week 168|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
172725|NCT00105157|Post-Hoc|Number of Patients With Virologic Responses at Week 168 in Combined Substudies|Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 168; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 168.|168 weeks|Analysis population is based on the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||Participants|||Number
172726|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 96 Weeks||96 weeks|"All patients who took study medication and had~any laboratory tests performed were included in the analysis."||Participants|||Number
172727|NCT00105157|Secondary|Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks||96 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
172728|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 96 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|96 weeks|||Participants|||Number
172729|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|96 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
172730|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172731|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172732|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172733|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172734|NCT00105157|Secondary|Number of Patients That Died by 96 Weeks||96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172735|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 96 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172736|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 96 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
173551|NCT00095498|Secondary|Change From Baseline in Platelets at Month 3|Laboratory hematology platelets|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
172737|NCT00105157|Secondary|Number of Patients With Serious CAEs at 96 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172738|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|96 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172739|NCT00105157|Secondary|Number of Patients Discontinued With Drug-related LAEs at 48 Weeks||48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
172740|NCT00105157|Secondary|Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks||48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
172741|NCT00105157|Secondary|Number of Patients With Drug-related LAEs at 48 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
172742|NCT00105157|Secondary|Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 weeks|All patients who took study medication and had any laboratory tests performed were included in the analysis.||Participants|||Number
172743|NCT00105157|Secondary|Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172744|NCT00105157|Secondary|Number of Patients That Discontinued With Serious CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172745|NCT00105157|Secondary|Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172746|NCT00105157|Secondary|Number of Patients That Discontinued With CAEs at 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172747|NCT00105157|Secondary|Number of Patients That Died by 48 Weeks||48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172748|NCT00105157|Secondary|Number of Patients With Serious Drug-related CAEs at 48 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172749|NCT00105157|Secondary|Number of Patients With Drug-related CAEs at 48 Weeks|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172750|NCT00105157|Secondary|Number of Patients With Serious CAEs at 48 Weeks|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172751|NCT00105157|Secondary|Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 weeks|All patients who took study medication were included in the analysis.||Participants|||Number
172752|NCT00105157|Secondary|Change From Baseline in CD4 Cell Count at Week 24|Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)|Baseline and Week 24|Observed failure approach assuming baseline-carry-forward for all failures, exclude other missing values. Baseline CD4 Cell Count (cells/mm3) was carried forward for patients who discontinued assigned therapy due to lack of efficacy.||CD4 Cell Count (cells/mm3)||95% Confidence Interval|Mean
172753|NCT00105157|Secondary|Number of Patients With Virologic Responses at Week 24|Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24|24 weeks|All patients who took study medication and had HIV RNA tests performed were included in the analysis.||Participants|||Number
172754|NCT00105157|Primary|Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24|Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients|Baseline and Week 24|Observed mean change from baseline in log10 Plasma HIV RNA for each group was calculated using the conventional imputation (replace HIV RNA <400 copies/mL by 400 copies/mL if signal detected, or 200 copies/mL if signal not detected). Missing values: baseline-carry-forward for all failures or discontinued due to lack of efficacy||HIV RNA (log10 copies/mL)||95% Confidence Interval|Mean
172755|NCT00105079|Secondary|Number of Patients Who Discontinued Treatment Due to Abnormal Laboratory Parameters|Routine clinical testing, including hematology and standard chemistry panel was performed at all study visits. Laboratory tests for a fasting lipid profile and fasting insulin determination were obtained at baseline, weeks 24 and 48, and the 4-week follow-up visit. The number of participants who discontinued treatment due to an abnormal laboratory result at any visit is reported.|baseline and all study visits (Up to Week 52)|Safety population included all randomized patients who received at least one dose of study medication.||participants|||Number
177549|NCT00025233|Primary|Frequency and Severity of Adverse Effects as Assessed by National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0||Up to 7 years||||||
172756|NCT00105079|Secondary|Number of Participants Assessed for Adverse Events (AEs)|Detailed information for Adverse Events and Serious Adverse Events will be represented in the SAE/AE section of PRS.|reported up to 28 days after the last dose of study treatment. (Up to 52 weeks)|Safety population included all randomized patients who received at least one dose of study medication||participants|||Number
172757|NCT00105079|Secondary|Change From Baseline in Cluster Differentiation Antigen 4 Positive (CD4+) Lymphocyte Count|Summary statistics for change from baseline in CD4+ lymphocyte count were presented by treatment arm. Change from baseline in CD4+ lymphocyte count was derived as follows: Change from baseline = (CD4+ count at week x) – (CD4+ count at baseline).|Baseline to Week 48|ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.||cells/mm^3||95% Confidence Interval|Median
172758|NCT00105079|Secondary|Change From Baseline in HIV-1 RNA Viral Load|Descriptive statistics for change from baseline in log10 transformed plasma HIV-1 RNA load (copies/mL) were presented by treatment arm. Logarithmic transformation (base 10) was applied to HIV-1 RNA viral load at baseline and at each study visit. Change from baseline in plasma HIV-1 RNA was derived as follows: Change from baseline = Log10 (HIV-1 RNA at week x) – Log10 (HIV-1 RNA at baseline)|Baseline to Week 48|ITT Population. (n) in each of the categories is the number of participants from the ITT population who had data available at that time point.||copies/mL||95% Confidence Interval|Mean
172759|NCT00105079|Secondary|Number of Patients With HIV-1 RNA Viral Load <50 and <400 Copies/mL|"The secondary objectives of the study were to evaluate the safety, adherence, and tolerability of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL and the number of participants with HIV-1 RNA results <400 copies/mL are reported."|Week 48|Intent-to-Treat Population||participants|||Number
172760|NCT00105079|Primary|Number of Patients With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Viral Load <50 Copies/mL|"The primary objective of this study was to evaluate the efficacy of saquinavir/ritonavir BID plus emtricitabine/tenofovir QD versus lopinavir/ritonavir BID plus emtricitabine/tenofovir QD in treatment-naïve HIV-1 infected adults.~Blood samples for HIV-1 RNA viral load measurement were collected at the Week 48 clinic visit. The number of participants with HIV-1 RNA results <50 copies/mL is reported."|Week 48|intent-to-treat (ITT) Population||participants|||Number
172761|NCT00105066|Post-Hoc|Homa Insulin Sensitivity|Homeostatic Model Assessment of insulin sensitivity|4.5 months|Participants with complete data.||HOMA Score||Standard Deviation|Mean
172762|NCT00105066|Primary|Change in Flow Mediated Dilation (FMD)|to evaluate improvement in endothelial function|Baseline and 4.5 months|Participants with complete data.||percentage change in diameter||Standard Deviation|Mean
172763|NCT00105066|Primary|Change in Arterial Stiffness Compared to Baseline||Baseline and 4.5 months|||meters / second||Standard Deviation|Mean
172764|NCT00105027|Secondary|Adverse Ocular Outcomes||36 months||||||
172765|NCT00105027|Secondary|Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography||36 months||||||
172766|NCT00105027|Secondary|Changes From Baseline in Best-corrected ETDRS Visual Acuity Score||36 months||||||
172767|NCT00105027|Primary|The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit|Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.|Change from baseline to 12 months|||Participants|||Number
172768|NCT00105001|Secondary|Progression-free Survival|"Percentage of patients with progression-free survival, estimated by cumulative incidence methods~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|At 6 months and then every year thereafter, up to 5 years|||percentage of participants|||Number
172769|NCT00105001|Secondary|Overall Survival|"Percentage of patients surviving, estimated by cumulative incidence methods~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|At 6 months and then every year thereafter, up to 5 years|||percentage of participants|||Number
172770|NCT00105001|Secondary|Incidence of High-dose Corticosteroid Utilization.|"Percentage of patients utilizing high-dose corticosteroid (as a surrogate marker for reduction of acute GVHD), estimated by cumulative incidence methods.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|150 days after transplant|||percentage of participants|||Number
172771|NCT00105001|Secondary|Incidence of Non-relapse Mortality|"Percentage of NRM as estimated by cumulative incidence methods with competing risks.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|200 days after transplant|||percentage of participants|||Number
172937|NCT00102687|Secondary|Baseline Absolute Neutrophil Count (ANC) Values|The median values for ANC based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for ANC. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population||x10^9/L||Full Range|Median
172772|NCT00105001|Primary|Incidence of Grades II-IV Acute GVHD|"Percentage patients with grades II-IV GHVD, estimated by cumulative incidence methods.~Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)” Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198"|150 days after transplant|||percentage of participants|||Number
172773|NCT00104884|Primary|Proportion of Patients With Response to Depsipeptide|"Response is evaluated using Solid Tumor Response Criteria (RECIST) and defined as either complete repose (CR) or partial response (PR).~Per RECIST criteria, CR = disappearance of all target and nontarget lesions; PR = at least 30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits."|Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 3 years from study entry, up to 3 years|The study was terminated early due to slow accrual with final accrual of 4 patients. There are no plans to conduct a formal analysis for any outcome measure.||percentage of participants||95% Confidence Interval|Number
172774|NCT00104871|Primary|Participant Tumor Response Assessed by RECIST|Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))|Two participants were not evaluable for response.||participants|||Number
172775|NCT00104871|Secondary|Progression-free Survival Assessed by RECIST|Progression-free survival (PFS) is measured from the first day of treatment to the first observation of disease progression or death due to any cause. PFS is reported as number of participants who had no disease progression or death for any reason at 6 months following treatment.|At 6 months||||||
172776|NCT00104871|Primary|Objective Tumor Response Rate Assessed by RECIST|Response Rate calculated as number of participants with Complete or Partial Response divided by total participants. Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Baseline to 12 weeks|Two participants were not evaluable for response.||participants|||Number
172777|NCT00104728|Secondary|Frequency of Toxicity Related to Study Treatment|Review of adverse events utilizing Common Toxicity Criteria (CTC) V3. To estimate the safety, tolerability, and feasibility of preoperative ZD1839 in patients with resectable Stage IA/IB, II and selected IIIA NSCLC by evaluating toxicity and operability after preoperative ZD1839.|3 years||||||
172778|NCT00104728|Primary|Overall Response Rate (ORR)|Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Investigators planned to use this pilot study of neoadjuvant ZD1839 in patients with resectable NSCLC to specifically correlate molecular parameters to the primary clinical study endpoint clinical response assessed by CT response and PET scan response of the primary tumor.|3 years||||||
172779|NCT00104650|Secondary|Hypercalcemia|Occurrence of hypercalcemia at grade 3 or 4 according to CTCAE v3 criteria|Day 1, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.||Participants|||Number
172780|NCT00104650|Secondary|Skeletal Related Events|Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1, week 25|All participants exposed to investigational product during the treatment phase.||Participants|||Number
172781|NCT00104650|Secondary|Time to First Skeletal Related Event|Time from study day 1 to first Skeletal Related Event (SRE), defined as >1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1, week 25|All participants exposed to investigational product during the treatment phase. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject who experienced a skeletal related event is presented.||Participants|||Number
172782|NCT00104650|Secondary|Percent Change of Serum CTX From Baseline to Week 25|Percent change from baseline to week 25 in Type I serum C-Telopeptide (CTX), calculated using ((week 25 value - baseline value) / baseline value ) x 100.|Baseline, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx and had available data.||Percent change||Standard Deviation|Mean
172783|NCT00104650|Secondary|Duration of Maintaining uNTX (Corrected by Creatinine) < 50nmol/mmol|Time from the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) to the 1st occurrence of uNTx above 50 nmol BCE/mmol up to week 25. For participants who remained below 50 nmol BCE/mmol, the time is censored at the time of last evaluation of uNTx up to week 25.|Day 1, week 25|Treatment Phase Primary Analysis Subset. Median was not reached in at least 1 treatment arm. In lieu of the median, the number of subject whose uNTX (corrected by creatinine) less than 50nmol/mmol is presented.||Participants|||Number
172832|NCT00104299|Secondary|The Duration of Remission (BVAS=0), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups|Duration of remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of glucocorticoid by 6 months post-randomization to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.|18 months post-randomization|Intent-to-treat||Days||95% Confidence Interval|Number
172784|NCT00104650|Secondary|Time to Reduction of uNTX (Corrected by Creatinine) to <50nmol/mmol|Kaplan-Meier estimate of the median time from enrollment to the 1st occurrence of uNTx below 50 nmol BCE/mmol (corrected by creatinine) up to week 25. For participants whose uNTx does not go below 50 nM BCE/mM creatinine, the time is censored at time of last evaluation of uNTx by week 25.|Day 1, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.||Days||Inter-Quartile Range|Median
172785|NCT00104650|Secondary|Percent Change of uNTx (Corrected by Creatinne) From Baseline to Week 25|Percent change from baseline to week 25 urinary N-telopeptide (uNTX) calculated using ((week 25 value - baseline value) / baseline value ) x 100.|Baseline, week 25|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.||Percent change||Standard Deviation|Mean
172786|NCT00104650|Secondary|uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 25|Urinary N-telopeptide (uNTX) corrected by creatinine < 50 nmol/mmol at week 25.|25 weeks|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.||Participants|||Number
172787|NCT00104650|Primary|uNTx (Corrected by Creatinine) < 50 Nmol/mmol at Week 13|Urinary N-telopeptide (uNTx) corrected by creatinine (uNTx/Cr) < 50 nmol/mmol at week 13.|13 weeks|All participants who are randomized to the treatment phase, receive at least one dose of treatment phase investigational product, and have treatment phase baseline measurements of uNTx and at least one treatment phase post-baseline measurement of uNTx.||Participants|||Number
172788|NCT00104637|Secondary|O2 Saturation at Peak Exercise|O2 Saturation at Peak Exercise measured during the Cardiopulmonary exercise test.|Period 1 and Period 3 ( within 8 weeks)|||percentage of oxygen saturation||95% Confidence Interval|Least Squares Mean
172789|NCT00104637|Secondary|Oxygen Pulse|Oxygen pulse during Cardiopulmonary exercise test at peak exercise.|Period 1 and Period 3 ( within 8 weeks)|||ml/beat||95% Confidence Interval|Least Squares Mean
172790|NCT00104637|Secondary|A-a Gradient (Alveolar-arterial Gradient)|A-a gradient was measured with ABG breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)|||mm Hg||95% Confidence Interval|Least Squares Mean
172791|NCT00104637|Secondary|Partial Pressure of Oxygen (PO2) in Arterial Blood Gas (ABG)|Partial Pressure of Oxygen in ABG breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)|||mm Hg||95% Confidence Interval|Least Squares Mean
172792|NCT00104637|Secondary|Partial Pressure of Carbon Dioxide (PCO2) in Arterial Blood Gas (ABG)|Partial pressure of carbon dioxide in ABG performed breathing room air at rest.|Period 1 and Period 3 ( within 8 weeks)|||mm Hg||95% Confidence Interval|Least Squares Mean
172793|NCT00104637|Secondary|Diffusing Capacity of Carbon Monoxide (DLCO)|Carbon Monoxide Diffusing Capacity was measured on the same days as the pulmonary function tests.|Period 1 and Period 3 ( within 8 weeks)|||ml/min/torr||95% Confidence Interval|Least Squares Mean
172794|NCT00104637|Secondary|Borg Dyspnea(Scale That Measures Breathlessness) Score at Finish of 6 Minute Walk Test (6MWT)|Participants were asked to scale the breathlessness felt at the end of 6MWT from 0 to 10, with 0 being the least discomfort and 10 being the most discomfort in breathing.|Period 1 and Period 3 ( within 8 weeks)|||Scores on a scale||95% Confidence Interval|Least Squares Mean
172795|NCT00104637|Secondary|Forced Expiratory Volume in the First Second (FEV1 )|The volume of air exhaled in the first second. Data to calculate results for FEV1 was based on Period 1 only.|Period 1 ( 4 weeks)|||liters||95% Confidence Interval|Least Squares Mean
172796|NCT00104637|Primary|VO2 Peak (Oxygen Consumption at Peak Exercise)|Oxygen consumption at peak exercise was measured at scheduled timepoints during treatment periods 1 and 3.|Period 1 and Period 3 ( within 8 weeks)|||ml/kg/min||95% Confidence Interval|Least Squares Mean
172797|NCT00104637|Primary|6 Minute Walk Distance|The distance a subject walked within 6 minutes was measured and documented.|Period 1 and Period 3 ( within 8 weeks)|||meters||95% Confidence Interval|Least Squares Mean
172798|NCT00104637|Secondary|Pulmonary Function FVC (Forced Vital Capacity)|Data to calculate results for FVC was based on Period 1.|Period 1 (4 weeks)|||liters||95% Confidence Interval|Least Squares Mean
172799|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Gait/Balance Assessment|gait measures|1 year||07/2016||||
172800|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Prostate Volume/Prostate Specific Antigen Levels/Urinary Function|rectal ultrasound and blood test|1 year||07/2016||||
172801|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Glucose Tolerance/Lipid Metabolism|Oral glucose tolerance test (Glucose/Insulin), lipid profile, abdomen fat|1 year||07/2016||||
172802|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Pulsatile Growth Hormone Release|Overnight Growth hormone measures|1 year||12/2016||||
172803|NCT00104572|Secondary|Effect of Testosterone Gel vs. Anastrozole on Cognitive Function|MRI images|1 year||12/2016||||
172804|NCT00104572|Primary|Effect of Testosterone Gel vs. Anastrozole on Bone Mineral Density|bone mineral density lumbar spine|1 year|||g/cm2||Standard Deviation|Mean
172805|NCT00104520|Other Pre-specified|Minimum Concentration of Aztreonam Inhibiting 50% (MIC50) and 90% (MIC90) of All PA Isolates (μg/mL)|"The aztreonam susceptibility of PA isolates from sputum samples (collected at all visits) was assessed.~MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism).~MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism).~MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis."|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). No imputation methods were used for the analysis.||μg/mL|||Number
172806|NCT00104520|Other Pre-specified|Number of Participants With Other Pathogens|"Sputum samples were collected at all visits for quantitative and qualitative culture for Staphylococcus aureus, Burkholderia cepacia, Stenotrophomonas maltophilia, and Achromobacter xylosoxidans.~Number of participants with other pathogens at baseline and at the end of treatment (28 days) are reported."|Day 0 and Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). No imputation methods were used for the analysis.||Participants|||Number
172807|NCT00104520|Secondary|Change From Baseline in Pseudomonas Aeruginosa (PA) Log10 Colony Forming Units (CFU) Per Gram of Sputum|Sputum samples were collected at all participant visits of the study for analysis of microbiology endpoints. Sputum samples were processed for qualitative and quantitative culture of PA (each morphotype). Due to the skewness of the distribution of CFU data, the data were transformed using the base 10 logarithm, in an attempt to normalize the data and allow for parametric tests, before calculating changes. To account for zero values, 1 was added to each CFU measurement before being transformed. Any CFU data values where PA was not isolated from a valid culture were set to zero.|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). No imputation methods were used for the analysis.||Log10 PA CFUs/gram of sputum||Standard Error|Least Squares Mean
172808|NCT00104520|Secondary|Number of Hospitalization Days|Details of all hospitalizations, including the dates of admission and discharge, were recorded on the electronic case report form (eCRF).|Day 0 to Day 84|Analysis based on ITT population (all participants randomized to treatment who received at least part of one dose of study drug). No imputation methods were used for the analysis.||Days||Standard Deviation|Mean
172809|NCT00104520|Secondary|Percent Change in Forced Expiratory Volume in 1 Second (FEV1) (L)|"Spirometry was performed at each visit. FEV1 was recorded according to American Thoracic Society (ATS) guidelines.~FEV1(L) is the measurement of the volume of air (expressed in liters) exhaled in 1 second.~The percent change in this parameter from Day 0 to Day 28 was determined for each treatment group."|Day 0 to Day 28|Analysis based on ITT population (all participants who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to an AE or study drug intolerance. For all other missing data, LOCF imputation method was used.||Percent change in FEV1 (L)||Standard Error|Least Squares Mean
172810|NCT00104520|Secondary|Change in Cystic Fibrosis Questionnaire – Revised (CFQ-R) Respiratory Symptoms Scale (RSS) Score|The CFQ-R was administered at Day -28, baseline, Day 14, Day 28, and Day 84 (end of study). The endpoint was change in respiratory symptoms from baseline, assessed with the CFQ-R RSS (range of scores [units]: 0-100; higher scores indicate fewer symptoms).|Day 0 to Day 28|Analysis based on ITT population (all participants randomized to tx who received at least part of one dose of study drug). Missing baseline data were not imputed. Missing post-baseline data were imputed using worst-case value for participants who withdrew due to AE or study drug intolerance. For all other missing data, LOCF method was used.||Units on a scale||Standard Error|Least Squares Mean
172811|NCT00104520|Primary|Time to Need for Inhaled or Intravenous (IV) Antipseudomonal Antibiotics|The primary endpoint was time to need for a course of inhaled or IV antipseudomonal antibiotics with documented physician assessment of need for antibiotics. Antipseudomonal Antibiotic need was documented based on the presence of at least one of the following four symptoms predictive of pulmonary exacerbation: decreased exercise tolerance, increased cough, increased sputum / chest congestion, decreased appetite, or other.|Day 0 to Day 84 (end of study)|Analysis based on intents to treat (ITT) population (all participants randomized to treatment who received at least part of one dose of study drug).||Days||95% Confidence Interval|Median
172812|NCT00104416|Secondary|Serum Concentrations and Population (POP) Pharmacokinetic Parameters for Lamotrigine|Serum samples for participants on lamotrigine were analyzed with a validated analytical method based on solid phase extraction of serum followed by High-Performance Liquid Chromatography (HPLC) Mass Spectrometry (MS)/MS analysis. The lower limit of quantification (LLQ) for serum lamotrigine was 4 nanograms (ng)/milliliter (mL), using a 50 microliter (µL) aliquot of human serum with a higher limit of quantification (HLQ) of 4,000 ng/mL. PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study.|Blood samples drawn at Treatment Weeks 11, 15, and 19 (or last on-study measurement in Double-Blind Treatment Phase)|PK Population: Number of participants analyzed for PK data cannot be reported, as PK data from several different studies have been combined into one POP/PK analysis and cannot be separated by study.|||||
172813|NCT00104416|Secondary|Mean Change From Baseline in the Epworth Sleepiness Scale (ESS) 8-Item Total Score at Week 19 of the Double-Blind Treatment Phase|The ESS is an 8-item, self-administered questionnaire that measures excessive daytime sleepiness in adults. The instrument captures information on the extent to which the participant would be likely, or not, to fall asleep in certain situations. The stimulus question is: How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? Questions are answered on a 4-point scale (would never doze [0] to high chance of dozing [3]). The total score ranges from 0 to 24, where a higher score indicates a higher chance of dozing.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 55 and 51 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
172814|NCT00104416|Secondary|Mean Change From Baseline in the Seizure Severity Questionnaire (SSQ) Global Bother Score at Week 19 Double-Blind Treatment Phase|The SSQ is a self-reported instrument developed to assess the severity of seizures and seizure symptoms. The scale consists of 10 major clinical features/symptoms of seizures that the participants rate on a 7-point Likert scale (ranging from very mild/helpful/no bother at all [1] to very severe/no help/bothersome [7]). The Global Bother Domain is the primary score used for the analysis of the SSQ and has scores ranging from 1 to 7.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 68 and 67 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
172822|NCT00104416|Secondary|Number of Participants With Improved Satisfaction With Seizure Control on the Subject Satisfaction Questionnaire in the Double-Blind Treatment Phase|Participants were asked to rate their satisfaction with their seizure control compared to their seizure control prior to initiating study drug on a 7 point scale: marked deterioration (1), moderate deterioration (2), mild deterioration (3), no change (4), mild improvement (5), moderate improvement (6), or marked improvement (7).|Week 19 (or last on-study assessment in Double-Blind Treatment Phase)|ITT Population. Participant satisfaction was not assessed for 2 participants in each of the Placebo and LTG XR groups, respectively.||participants|||Number
177807|NCT00006178|Secondary|Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney)|measure 6 months after intervention|6 month after intervention|||mL/min||Standard Deviation|Mean
172815|NCT00104416|Secondary|Mean Change From Baseline in the Adverse Experience Profile (AEP) Total Score at Week 19 of the Double-Blind Treatment Phase|The AEP is a list of 19 items covering many possible side effects attributable to drug treatment. The participants respond by assessing how much each event has been a problem for them over the past 4 weeks (1=Never a Problem to 4=Always a Problem). Each individual item can be examined; an overall adverse events score is calculated as the sum of the scores across the 19 items. The AEP total score ranges from 19 to 76, with a higher score indicating a higher degree of adverse event severity.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 65 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
172816|NCT00104416|Secondary|Mean Change From Baseline in the Quality of Life in Epilepsy-31-P (QOLIE-31P) Overall Score at Week 19 of the Double-Blind Treatment Phase|The QOLIE-31 is a 31-item questionnaire that evaluates the participants' perception of his or her quality of life in 7 domains: seizure worry, emotional well being, energy/fatigue, cognitive functioning, medication effects, social functioning, and overall quality of life. Each domain (with scores ranging from 0 to 100) is summed and divided by the total number of questions that were answered. The overall score is derived by weighting and then summing up the seven domain scores.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 55 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
172817|NCT00104416|Secondary|Mean Change From Baseline in the Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) 6-Item Total Score at Week 19 of the Double-Blind Treatment Phase|The NDDI-E is a self-reported questionnaire composed of 46 brief phrases/words to identify mood disorders across the spectrum of depression. It was developed to capture depressive moods that are co-morbid with the disease of epilepsy or its treatment as well as to measure the depressive state of the participant. All phrases are measured on a 4-point Likert scale of Never (1) to Always/often (4) and refer to the participants’ mood over the past week. Scoring is comprised of a total mood score calculated by summing the scores of 6 specific items (from 6=never to 24=always or often).|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 65 participants in both the Placebo and LTG XR groups. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
172818|NCT00104416|Secondary|Mean Change From Baseline in the Center for Epidemiological Studies-Depression Scale (CES-D) Total Score at Week 19 of the Double-Blind Treatment Phase|The 20-item CES-D questionnaire is self-administered and asks respondents to report the frequency to which the 20 events were experienced over the past week. A 4-point Likert scale is used and ranges from rarely or none of the time (0) to most or all of the time (3). The total score, a sum across the 20 items (ranging from 0 to 60), determines the extent to which a participant may be experiencing depression. Higher scores indicate a higher severity of depression.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 64 and 59 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
172819|NCT00104416|Secondary|Mean Change From Baseline in the Profile of Mood State (POMS) Mood Disturbance Total Score at Week 19 of the Double-Blind Treatment Phase|The POMS is a self-administered 65-item questionnaire that evaluates the participants' perception of their mood state in 6 areas: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Items are rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely), with higher scores indicating a more negative mood state. A total score (from 0 to 24) is obtained by summing the scores of the six domains.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population. The questionnaire was not completed by 53 and 57 participants in the Placebo and LTG XR groups, respectively. Only participants completing the questionnaire were included in the analysis of this outcome measure.||points on a scale||Standard Error|Least Squares Mean
172820|NCT00104416|Secondary|Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction or >=50% Increase From Baseline in Weekly PGTC Seizure Frequency for the Entire Continuation Phase, the Transition Phase, the Open-Label (OL) Phase, and the Last 8 Weeks of the OL Phase.|Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire CP (CP Week 1 up to Week 52); the Transition Phase (CP Week 1 up to Week 7); the Open-Label (OL) Phase (CP Week 8 up to Week 52); and the last 8 weeks of the Open Label Phase (CP Week 45 up to Week 52) minus the seizure frequency at Baseline. W, Week.|Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)|ITT Population for CP. Variability in participant numbers are due to not having any PGTC seizures during the Baseline Phase and study withdrawal prior to progressing to the next phase.||participants|||Number
172821|NCT00104416|Secondary|Percent Change From Baseline in Weekly PGTC Seizure Frequency During the Entire Continuation Phase (CP), the Transition Phase, the Open-Label Phase, and the Last 8 Weeks of the Open-Label Phase|Percent change from baseline is calculated as the number of seizures by week during the entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52) minus the number of seizures per week during the Baseline Phase (Baseline Week 1 through Week 8). A positive number equals a reduction in seizure frequency.|Entire CP (CP Week 1 up to Week 52), the Transition Phase (CP Week 1 up to Week 7), the Open-Label Phase (CP Week 8 up to Week 52), and the last 8 weeks of the Open-Label Phase (CP Week 45 up to Week 52)|ITT Population for CP: all participants who took at least one dose of study medication during the CP and had at least one post baseline seizure assessment during the CP. Variability in participant numbers are due to not having any PGTC seizures during the Baseline Phase and study withdrawal prior to progressing to the next phase.||percent change||Full Range|Median
172938|NCT00102687|Secondary|Change From Baseline in Platelets at the End of the Maintenance Study Period (Month 24)|The difference between platelet values at the end of the maintenance study period minus the platelet values at baseline.|24 months|Intent to treat population||x10^9/L||Full Range|Median
172823|NCT00104416|Secondary|Number of Participants With Improved Clinical Status on the Investigator’s Global Assessment in the Double-Blind Treatment Phase|The investigators rated the participants’ overall clinical status based on 7 clinical factors and an overall factor: seizure frequency, duration, and intensity; adverse experiences; social, intellectual, and motor functioning. Using a 7-point scale (marked deterioration [1], moderate deterioration [2], mild deterioration [3], no change [4], mild improvement [5], moderate improvement [6], or marked improvement [7]), the investigators assessed the participants’ status compared to their condition prior to initiating study medication.|Week 19 (or last on-study assessment in Double-Blind Treatment Phase)|ITT Population. Overall clinical status not assessed for 2 participants in each of the Placebo and LTG XR groups, respectively.||participants|||Number
172824|NCT00104416|Secondary|Change From Baseline in Body Weight at Week 19 of the Double-Blind Treatment Phase|Change from baseline in body weight is calculated as the Week 19 (or last on-study measurement in Double-Blind Treatment Phase) value minus the Baseline value.|Baseline and Week 19 (or last on-study measurement in Double-Blind Treatment Phase)|ITT Population||kilograms||Full Range|Median
172825|NCT00104416|Secondary|Number of Participants With the Indicated Time to >=50% Reduction in Seizure Frequency in the Double-Blind Treatment Phase|50% reduction in seizure frequency is defined as the time at which a participant first achieved and maintained a >=50% reduction in seizure frequency following exposure to at least 1 week of study drug.|Baseline through end of Double-Blind Treatment Phase (up to Week 19)|ITT Population||participants|||Number
172826|NCT00104416|Secondary|Percent Change From Baseline in PGTC Seizure Frequency During the Escalation Phase, the Maintenance Phase, and During the Last 8 Weeks of the Maintenance Phase of the Double-Blind Treatment Phase|Percent change from baseline is calculated as the number of seizures by week during the Escalation Phase (Treatment Week 1 up to Week 7), the Maintenance Phase (Treatment Week 8 up to Week 19), and during the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency.|Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Week 12 up to Week 19)|ITT Population. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase as a result they were not counted for this efficacy endpoint; an additional 2 and 1 participants in the Placebo and LTG XR group, respectively, were not counted in the Maintenance Phase (MP) or last 8 weeks of MP due to study withdrawal.||percent change||Full Range|Median
172827|NCT00104416|Secondary|Number of Participants With >=25%, >=50%, >=75%, or 100% Reduction in PGTC Seizure Frequency During the Entire Double-Blind (DB)Treatment Phase (TP), the Escalation Phase, the Maintenance Phase, and the Last 8 Weeks of the Maintenance Phase|Change in seizure frequency was calculated as the average seizure frequency during each of the following: the Entire DB Treatment Phase (Treatment Week 1 up to Week 19); the Escalation Phase (Treatment Week 1 up to Week 7); the Maintenance Phase (Treatment Week 8 up to Week 19); and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19), minus the seizure frequency at Baseline.|Entire DB Treatment Phase (Treatment Week 1 up to Week 19), Escalation Phase (Treatment Week 1 up to Week 7), Maintenance Phase (Treatment Week 8 up to Week 19), and the last 8 weeks of the Maintenance Phase (Treatment Week 12 up to Week 19)|ITT Population. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase, as a result they were not counted in this efficacy endpoint; an additional 2 and 1 participants in the Placebo and LTG XR group, respectively, were not counted in the Maintenance Phase (MP) or last 8 weeks of MP due to study withdrawal.||participants|||Number
172828|NCT00104416|Primary|Percent Change From Baseline in Weekly Primary Generalized Tonic-clonic (PGTC) Seizure Frequency During the Entire Double-Blind Treatment Phase|Percent change from baseline is calculated as the number of seizures by week during the Double-Blind Treatment Phase (Treatment Week 1 up to Week 19) compared to the number of seizures per week during the Baseline Phase (Baseline Week 1 up to Week 8). A positive number equals a reduction in seizure frequency. PGTC seizures are more commonly known as gran mal seizures.|Baseline through end of Double-Blind Treatment Phase (up to Week 19)|Intent-to-Treat (ITT) Population: all randomized participants who took at least one dose of study drug and had at least one post-baseline efficacy assessment in the Double-Blind Treatment Phase. One participant in each treatment group did not have any PGTC seizures during the Baseline Phase.||percent change||Full Range|Median
172829|NCT00104299|Post-Hoc|Number of Subjects Experiencing Serious Adverse Events|Number of subjects according to originally received treatment that experienced a serious adverse event through 18 months post-randomization or prior to being censored from analyses due to crossover, switching to open-label treatment, or best medical judgment for censor. Events are categorized by coded system organ classes (SOC). Within each SOC, a participant was counted once if the participant reported one or more events coded to that SOC.|Randomization to censor at Crossover, Open-label or Best Medical Judgment (up to 18 months post-randomization)|Intent-to-treat||participants|||Number
172830|NCT00104299|Secondary|Time to Complete Remission (BVAS=0, Off Glucocorticoids) From the Visit 1 Baseline Visit in the Two Treatment Groups|"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and completing taper of glucocorticoid by 6 months post-randomization.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat||Days||95% Confidence Interval|Number
172831|NCT00104299|Secondary|Time to Remission (BVAS=0) From the Visit 1 Baseline Visit in the Two Treatment Groups|"Time to complete remission is defined as the number of days from baseline visit (Visit 1) to a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat||Days||95% Confidence Interval|Number
172939|NCT00102687|Secondary|Change From Baseline in Platelets at the End of Initial Study Period (6 Months)|The difference between platelet values at the end of the initial study period minus the platelet values at baseline.|6 months|Intent to treat population||x10^9/L||Full Range|Median
172833|NCT00104299|Secondary|The Duration of Complete Remission (BVAS=0, Off Glucocorticoids), the Time to Limited and/or Severe Flare After Remission in the Two Treatment Groups|"Duration of complete remission is defined as a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and a completing taper of Prednisone to the first flare, BVAS/WG score of greater than 0, or an increase in Prednisone dosing.~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|18 months post-randomization|Intent-to-treat||Days||95% Confidence Interval|Number
172834|NCT00104299|Secondary|Percentage of Participants Who Have a BVAS/WG Score of 0 and Have Successfully Completed the Glucocorticoid Taper by 6 Months Post-randomization|"The 2-sided 95% CI of the percentage of participants who have a Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG)[1] of 0 and have successfully completed the glucocorticoid taper by 6 months post-randomization and the 2-sided 95% CI of the difference between two arms for assessing the superiority of rituximab to control~[1] The BVAS/WG is a disease activity index designed to document new or worsening clinically active vasculitis consisting of items divided into 9 organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease"|6 months post-randomization|Safety Sample||participants|||Number
172835|NCT00104299|Secondary|Rate of Selected Adverse Events Experienced by Participants Receiving Rituximab Versus Those Receiving Conventional Therapy|The adverse event rate for the following events considered related to vasculitis: Death; Grade 2 or higher leukopenia or thrombocytopenia; Grade 3 or higher infections; Hemorrhagic cystitis (grade 2 or lower needs confirmation by cytoscopy); Malignancy; Venous thromboembolic event (deep venous thrombosis or pulmonary embolism); Hospitalization resulting either from the disease or from a complication due to study treatment; Infusion reactions (within 24 hours of infusion) that result in the cessation of further infusions (including cytokine release allergic reaction); Cerebrovascular accident|Through common close-out (defined as 18 months after the last participant is enrolled in the trial)|Safety Sample||participants|||Number
172836|NCT00104299|Primary|Disease Remission|A Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) score of 0 with prednisone taper successfully completed at six months. The BVAS/WG is a validated disease activity index. The BVAS/WG is designed to document new or worsening clinically active vasculitis and consists of a set of items divided into nine organ based systems. BVAS/WG scores range from 0 to 63, with higher scores indicating more active disease.|6 months post-randomization|Intent-to-treat (ITT) sample with worst case imputation||Participants|||Number
172837|NCT00104247|Primary|Change in Blood Phenylalanine Levels From Baseline to Week 6.||baseline to week 6|||micromole per liter||Standard Deviation|Mean
172838|NCT00104234|Secondary|Change in Urinary Glycosaminoglycans (GAG) Level|Mean change in urinary GAG level for the first 72 weeks of rhASB treatment. For the rhASB/rhASB group, mean change was calculated for Week 72 -Baseline. For the placebo/rhASB, mean change was calculated for Week 96 - Week 24.|72 weeks|rhASB/rhASB and placebo/rhASB groups were combined for the analysis, representing 72 weeks of rhASB treatment in each group.||microgram/mg creatinine||Standard Deviation|Mean
172839|NCT00104234|Secondary|3-Minute Stair Climb|Mean change in number of stairs climbed per minute in 3 minutes. Mean change is the mean difference between the 3-Minute Stair Climb at 96 weeks and that measured before first ever treatment with rhASB. Mean change is calculated for Week 96 – Baseline for the rhASB/rhASB group and for Week 96 – Week 24 for the placebo/rhASB group.|Baseline ASB-03-05 through week 96 of ASB-03-06.|The efficacy analysis included all subjects who continued in the extension study (ASB-03-06) except 1 subject from the placebo/rhASB group who missed the Week 96 measurement.||stairs/min||Standard Deviation|Mean
172840|NCT00104234|Primary|12-Minute Walk Test|Mean change in meters walked in 12 minutes. Mean change is the mean difference between the 12-Minute Walk Test at 96 weeks and that measured before first ever treatment with rhASB. For the rhASB/rhASB group, mean change is calculated for Week 96 – Baseline. For the placebo/rhASB group, mean change is calculated for Week 96 – Week 24.|Baseline of ASB-03-05 through week 96 of ASB-03-06|The efficacy analysis included all subjects who continued in the extension study (ASB-03-06) except the 1 subject from the rhASB/rhASB group and 1 subject from the placebo/rhASB group who missed the Week 96 measurement.||meters||Standard Deviation|Mean
172841|NCT00104104|Primary|The Number of Participants With Disease Progression||24 Months|Safety Population; enrolled patients who received at least one dose of study medication.||Participants|||Number
172842|NCT00104104|Secondary|Zoledronic Acid Concentrations|Samples for drug concentration analysis were drawn at 10 and 15 minutes into the infusion for participants in the 15-minute infusion group and at 25 and 30 minutes into the infusion for patients in the 30-minute infusion group. The mean and median zoledronic acid concentrations were greater in the 15-minute group than in the 30-minute group at both sampling timepoints.|24 months|The pharmacokinetic (PK) population was analyzed for zoledronic acid concentration. Participants were considered to be in the PK population if they had evaluable PK data.||ng/mL||Standard Deviation|Mean
172843|NCT00104104|Secondary|Time to First Significant Increase in Serum Creatinine|Median time to event in participants who had a clinically relevant increase in serum creatinine.|Up to 24 months|Safety Population; enrolled patients who received at least one dose of study medication. The medians shown are only for patients who had a significant increase by 24 months.||weeks||Full Range|Median
172844|NCT00104104|Secondary|The Number of Participants With a Significant Increase in Serum Creatinine at 24 Months|Serum Creatinine was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.|Baseline and 24 Months|Safety Population; enrolled patients who received at least one dose of study medication.||Participants|||Number
172845|NCT00104104|Primary|The Number of Participants With a Significant Increase in Serum Creatinine at 12 Months|The primary renal safety endpoint was the number of participants with a clinically relevant increase in serum creatinine at 12 months. Serum creatinine was determined prior to each zoledronic acid infusion for all Participants and was considered to be significantly increased if there was an increase of 0.5 mg/dL or more or a doubling of the baseline serum creatinine value.|Baseline and 12 Months|Safety Population: enrolled patients who received at least one dose of study medication, exluding site 74.||Participants|||Number
173552|NCT00095498|Secondary|Change From Baseline in Platelets at Month 1|Laboratory hematology platelets|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
172846|NCT00104052|Primary|Number of Participants With a Sustained Virologic Response (SVR) at 24 Weeks Post-treatment|SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment|Up to 48-week treatment duration. Follow-up of 24 weeks.|Carry Forward analysis of participants who received at least one dose of study medication. This dataset includes one subject with undetectable HCV-RNA at Follow-up Week 12 (FW 12) but missing data at FW 24; this subject was considered a sustained responder in the Carry Forward analysis.||Participants|||Number
172847|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.||mg/dL||95% Confidence Interval|Least Squares Mean
172848|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.||mg/dL||95% Confidence Interval|Least Squares Mean
172849|NCT00103857|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104|HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.|Week 104|The Extension Full Analysis Set (EFAS) included all patients with a baseline value and ≥1 value in the extension (post-Week 54) for this outcome. Data following glycemic rescue were treated as missing. For EFAS patients with no data at Week 104, the last observed measurement was carried forward.||Percent||95% Confidence Interval|Least Squares Mean
172850|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.||mg/dL||95% Confidence Interval|Least Squares Mean
172851|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54|Change from baseline at Week 54 is defined as Week 54 minus Week 0.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.||mg/dL||95% Confidence Interval|Least Squares Mean
172852|NCT00103857|Secondary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54|HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.|Week 54|The Phase B Full Analysis Set (BFAS) included all patients with a baseline value and ≥1 value in Phase B (post-Week 24) for this outcome. Data following glycemic rescue were treated as missing. For BFAS patients with no data at Week 54, the last observed measurement was carried forward to Week 54.||Percent||95% Confidence Interval|Least Squares Mean
172853|NCT00103857|Secondary|Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.||mg/dL||95% Confidence Interval|Least Squares Mean
172854|NCT00103857|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.||mg/dL||95% Confidence Interval|Least Squares Mean
172855|NCT00103857|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.||Percent||95% Confidence Interval|Least Squares Mean
172856|NCT00103844|Secondary|Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib|Number of participants from which blood samples were collected for population PK studies.|Day 8: pretreatment trough sample, a sample between 30 minutes and 3 hours following treatment, a sample between 5 and 8 hours following treatment, and a sample at 12 hours, prior to the next dose.|Blood samples that were to contribute to PK modeling were collected from 78 participants,to be included in separate population PK analyses. Although blood sample collection was listed as a secondary endpoint, no study-specific PK analyses were planned for this report.||participants|||Number
172857|NCT00103844|Secondary|Health-Related Quality of Life Prior to Crossover|Health-related quality of life as measured by Functional Assessment of Cancer Therapy-General (FACT-G). FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, & SWB score change of 2 or more=minimal clinical important change.|Every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment. Last questionnaire was to be completed at first follow-up visit after off-study date.|Since single-arm quality-of-life data are not interpretable in a non-comparative trial, these data were not analyzed.||Units on a Scale|||Number
172871|NCT00103740|Secondary|Number of Participants With a Partial Disease Relapse During the Extended Observation Period|Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at Month 6 and at least 1.25 times the upper normal limit.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||participants|||Number
172858|NCT00103844|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths and Hematologic Toxicities Prior to Crossover|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously from baseline through 2 years|All treated participants||Participants|||Number
172859|NCT00103844|Secondary|Cytogenetic Response After Crossover|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (0% Ph+ cells in metaphase in bone marrow) or Partial CyR (>0% to 35% Ph+ cells in metaphase in bone marrow).|every 12 week period out to 2 years and off-study timepoints; restricted to postcrossover measurements|Participants evaluable for after crossover response||Participants|||Number
172860|NCT00103844|Secondary|CHR After Crossover|Participants achieving CHR after crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Weekly for 12 weeks, then after every 12 week period out to 2 years; restricted to postcrossover measurements.|Participants evaluable for response after crossover||Participants|||Number
172861|NCT00103844|Secondary|Major Molecular Response (MMR)|Number of participants Achieving MMR. MMR is defined as ≤3 log reduction (ie, international ratio ≤0.1), in BCR-ABL levels from the standardized baseline value of BCR-ABL: Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL: Control gene ratio by the lab-specific conversion factor.|Pretreatment, then after every 4 weeks for 12 weeks, then after every 12 week period out to 2 years; restricted to precrossover measurements.|Participants assessed for MMR only||participants|||Number
172862|NCT00103844|Secondary|Time to CHR Prior to Crossover|Median time from first dosing date to date of CHR. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Baseline (within 4 weeks of Day 1), weekly until Week 12, then every 12 weeks until crossover or off-study; restricted to precrossover measurements.|Number of participants achieving CHR in each treatment group||weeks||Full Range|Median
172863|NCT00103844|Secondary|Duration of Complete Hematologic Response (CHR)|Percentage of participants who achieved CHR and did not progress at specified time points. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|12 months, 24 months|Number of participants achieving CHR in each treatment group||percentage of participants|||Number
172864|NCT00103844|Secondary|Complete Hematologic Response (CHR) at Any Time Prior to Crossover|Participants achieving CHR prior to crossover. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm³; no blasts or promyelocytes in peripheral blood; < 5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤ 20%; no extramedullary involvement. Confirmed CHR is defined as CHR maintained at least 4 weeks after first documented at ≥ Day 14. Failure to maintain criteria of CHR was defined by 2 or more consecutive records of non-response.|Baseline (within 4 weeks of Day 1), weekly until Week 12 and then every 12 weeks until crossover or off-study; restricted to precrossover measurements.|||Participants|||Number
172865|NCT00103844|Secondary|Time to MCyR Prior to Crossover|Median time from first dosing date to date of MCyR|Baseline (within 4 weeks of Day 1), every 12 weeks, at crossover or off-study timepoints; restricted to precrossover measurements.|Population consists of the number of responders in each treatment group||months||Full Range|Median
172866|NCT00103844|Secondary|Duration of MCyR at 24 Months|Percentage of participants who achieved MCyR and did not progress at 24 months.|24 Months|In the imatinib group, the 24 months timepoint was beyond the maximum observed time.||Percentage of Participants|||Number
172867|NCT00103844|Secondary|Duration of MCyR at 12 Months and 18 Months|Percentage of participants who achieved MCyR and did not progress at 12 and 18 months.|12 months, 18 months|||percentage of participants.|||Number
172868|NCT00103844|Secondary|MCyR at Any Time Prior to Crossover|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as CCyR (0% Ph+ cells in metaphase in bone marrow) or PCyR (>0% to 35% Ph+ cells in metaphase in bone marrow).|Baseline (within 4 weeks of Day 1), every 12 weeks until crossover or off-study timepoints. Restricted to precrossover measurements.|||Participants|||Number
172869|NCT00103844|Primary|Number of Participants With Major Cytogenetic Response (MCyR) at Week 12|Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; >0% to 35% Ph+ cells in metaphase in bone marrow).|Week 12|All randomized subjects||Participants|||Number
172870|NCT00103740|Secondary|Number of Participants With a Disease Relapse During the Extended Observation Period|Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.|8 years was maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||participants|||Number
178115|NCT00000136|Primary|Mortality||All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial.|||participants|||Number
172872|NCT00103740|Secondary|Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period|Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||participants|||Number
172873|NCT00103740|Secondary|Change in Pain Interference at Day 182|Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.||units on a scale||Standard Deviation|Mean
172874|NCT00103740|Secondary|Change in Pain Severity at Day 182|Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.||units on a scale||Standard Deviation|Mean
172875|NCT00103740|Secondary|Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28|Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. Central laboratory reference ranges for serum alkaline phosphatase: 31-110 U/L (female & male 20-58 years) and 35-115 U/L (female & male >58 years).|Day 28|Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis.||participants|||Number
172876|NCT00103740|Secondary|Time to First Therapeutic Response|Therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.|182 days|Intent-to-treat population: all randomized patients.||days||Inter-Quartile Range|Median
172877|NCT00103740|Secondary|Relative Change in Urine α-CTx in ug/mmol at Day 10|The percent change in urine α-CTx from baseline to Day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.||percent change||Standard Deviation|Mean
172878|NCT00103740|Secondary|Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10|The percent change in serum C-telopeptide from baseline to Day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.||percent change||Standard Deviation|Mean
172879|NCT00103740|Secondary|Relative Change in Serum Alkaline Phosphatase in U/L at Day 28|The percent change in serum alkaline phosphatase from baseline to Day 28 was measured.|Baseline and 28 days|Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis.||percent change||Standard Deviation|Mean
172880|NCT00103740|Primary|Number of Patients Who Had Therapeutic Response at 6 Months|A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months.|Baseline, 6 months|Modified intent to treat population: all randomized patients with both baseline and at least one post-baseline serum alkaline phosphatase measurement. Missing values at 6 months were imputed using the last post-baseline measurement prior to 6 months.||participants|||Number
172881|NCT00103662|Secondary|Graft Durability at 12 Months Post Transplantation|The proportion of participants maintaining a durable graft at 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 13|Participants who received a stem cell transplant and were evaluable at 12 months post-transplant||proportion of participants|||Number
172882|NCT00103662|Secondary|Graft Durability at 6 Months Post Transplantation|The proportion of participants maintaining a durable graft at 6 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 7|Participants who received a stem cell transplant and were evaluable at 6 months post-transplant||proportion of participants|||Number
172883|NCT00103662|Secondary|Graft Durability at 100 Days Post Transplantation|The proportion of participants maintaining a durable graft at 100 days post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Day 138|Participants who received a stem cell transplant and were evaluable at 100 days post-transplant||proportion of participants|||Number
172884|NCT00103662|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.|Up to Month 13|Participants who received a stem cell transplant||Days||Inter-Quartile Range|Median
172885|NCT00103662|Secondary|Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment|The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.|Up to Month 13|Participants who received a stem cell transplant.||Days||Inter-Quartile Range|Median
172886|NCT00103662|Secondary|Median Number of Days to ≥6*10^6 CD34+ Cells/kg|The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6*10^6 CD34+ cells/kg) for transplantation.|up to Day 8|Intent-to-treat population||Days||Inter-Quartile Range|Median
172887|NCT00103662|Secondary|Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 2*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-Treat Population||proportion of participants|||Number
172888|NCT00103662|Secondary|Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-Treat Population||proportion of participants|||Number
172889|NCT00103662|Secondary|Number of Participants With Adverse Events|Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.|up to Day 38|Primary Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Four participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.||participants|||Number
172890|NCT00103662|Primary|Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.|Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis. Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.|up to Day 6|Intent-to-Treat Population||proportion of participants|||Number
172891|NCT00103610|Secondary|Graft Durability at 12 Months Post Transplantation|The proportion of participants maintaining a durable graft 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 13|Participants who received a stem cell transplant and were evaluable at 12 months post-transplant||proportion of participants|||Number
172892|NCT00103610|Secondary|Graft Durability at 6 Months Post Transplantation|The proportion of participants maintaining a durable graft at 6 months post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Month 7|Participants who received a stem cell transplant and were evaluable at 6 months post-transplant||proportion of participants|||Number
172893|NCT00103610|Secondary|Graft Durability at 100 Days Post Transplantation|The proportion of participants maintaining a durable graft at 100 days post transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.|approximately Day 138|Participants who received a stem cell transplant and were evaluable at 100 days post-transplant||proportion of participants|||Number
172894|NCT00103610|Secondary|Median Number of Days to Platelet (PLT) Engraftment|The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13|Participants who received a stem cell transplant||Days||Inter-Quartile Range|Median
172895|NCT00103610|Secondary|Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment|The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint. Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day. Time to engraftment corresponded to the first day that the criteria were met.|Up to Month 13|Participants who received a stem cell transplant.||Days||Inter-Quartile Range|Median
172896|NCT00103610|Secondary|Median Number of Days of Apheresis Required to Achieve >=5*10^6 CD34+ Cells/kg|The Kaplan Meier estimate of median number of days (number of days at which 50% of participants reached the threshold, accounting for censored values) in each treatment arm to collect the target number of cells (≥5*10^6 CD34+ cells/kg) for transplantation. Central laboratory values were used.|up to Day 8|Intent-to-Treat Population.||Days||Inter-Quartile Range|Median
172897|NCT00103610|Secondary|Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis|Proportion of participants achieving a target of >=2*10^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.|up to Day 8|Intent-to-treat Population||proportion of participants|||Number
172898|NCT00103610|Secondary|Number of Participants With Adverse Events|Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.|up to Day 38|Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Three participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.||participants|||Number
172899|NCT00103610|Primary|Proportion of Participants Able to Achieve Target (≥ 5*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis|Proportion of participants achieving a target of ≥ 5*10^6 CD34+ cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant’s value was calculated as the sum of all daily values collected over the 4 apheresis days.|Days 5 to 8|Intent-to-Treat Population||proportion of participants|||Number
172900|NCT00103506|Secondary|Number of Participants With Serious Adverse Events (SAEs)|A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006)|Safety population included all the participants who received at least one dose of study drug. Here ‘N’ (number of participants analyzed) signifies those participants who were evaluable for this measure.||Participants|||Number
172901|NCT00103506|Secondary|Overall Survival|The OS is defined as the time from the date of first dose of study drug to date of death from any cause. If the participant is alive or the vital status is unknown, the participant will be censored at the date the participant will be last known to be alive.|Up to 9 years and 5 months (From date of first participant randomization [20 December 2004] to cut-off date for final survival analysis (16 May 2014)|||months||95% Confidence Interval|Median
172902|NCT00103506|Primary|Time to Progression (TTP)|Median time to progression of disease is assessed according to International Myeloma Working Group (IMWG) criteria or death from any cause. IMWG criteria: increase of >=25% from lowest level in Serum M-component or (the absolute increase must be >=0.5 gram per deciliter [g/dL]); Urine M component or (the absolute increase must be >=200 milligram per 24 hour. Only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase >10 mg/dL. Bone marrow plasma cell percentage >=10%. Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing. Development of hypercalcemia. Participants who died or dropped out due to any reason without progression will be censored with the day of death or drop-out, respectively and who are alive at the end of the study without any progression was censored with the last available date.|Up to 1 year and 4 months (From date of first participant randomization [20 December 2004] up to interim analysis cut-off date [28 April 2006])|Intent-to-treat (ITT) included all the randomized participants.||Months||95% Confidence Interval|Median
172903|NCT00103311|Secondary|Overall Survival|Will be estimated using the product-limit method of Kaplan and Meier by arm.|From the date of registration to the date of death, assessed up to 12 months|||months||95% Confidence Interval|Median
172904|NCT00103311|Secondary|Progression-free Survival|Will be estimated using the product-limit method of Kaplan and Meier by arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|From the date of registration to the date of documented PSA progression, assessed up to 6 months|||weeks||95% Confidence Interval|Median
172905|NCT00103311|Primary|Objective Response (CR or PR) as Determined by the RECIST Criteria|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 5 years|||participants|||Number
172906|NCT00103259|Secondary|Overall Survival on Step 1|Overall survival was defined as time from registration on step 1 to death from any cause. It was evaluated in all 61 eligible and treated patients.|Survival was assessed every 3 month within 2 years and every 6 months betwen 2 and 3 years|61 eligible and treated patients were included in the analysis||months||95% Confidence Interval|Median
172907|NCT00103259|Secondary|Progression-free Survival on Step 1|Progression-free survival was defined as time from registration to step 1 to disease recurrence or death from any cause, whichever occurred first. Disease progression was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions.|Every 3 months for first 2 years from protocol entry, then every 6 months until 3 years from study entry|61 eligible and treated patients were included in the analysis||months||95% Confidence Interval|Median
172908|NCT00103259|Secondary|Response Rate on Step 2|Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|Tumor response was assessed after every 2 cycles until progression or intolerable toxicity with maximum of 3 years|10 eligible and treated patients who progressed on bortezomib and crossed over to bortezomib and irinotecan arm were included in the analysis||percentage of participants||90% Confidence Interval|Number
172909|NCT00103259|Primary|Response Rate on Step 1|Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) v1.0, and response rate was defined as the proportion of patients with a complete response or partial response among all eligible and treated patients. Complete response was defined as disappearance of all tumor lesions. Partial response was defined as at least a 30% decrease in the sum of the longest diameters of target lesions.|Tumor response was assessed every 2 cycles until progression or intolerable toxicity with maximum of 3 years|61 eligible and treated patients were included in the analysis||percentage of participants||90% Confidence Interval|Number
172910|NCT00103207|Secondary|Time to Progression by Smoking Status|Medians of time to progression by smoking status are reported.|Progression assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline|Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis.||Months||95% Confidence Interval|Median
172911|NCT00103207|Secondary|Overall Survival by Smoking Status|Medians of overall survival by smoking status are reported.|Overall survival assessed every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years. Smoking status evaluated at baseline|Only eligible and treated patients with confirmed diagnosis and smoking status data are included in the analysis.||Months||95% Confidence Interval|Median
172936|NCT00102687|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC) at the End of Initial Study Period (6 Months)|The difference between ANC values at the end of the initial study period minus the ANC values at baseline.|6 months|Intent to treat population||x10^9/L||Full Range|Median
172912|NCT00103207|Secondary|Time to Progression|Time to progression is defined as time from study entry until disease progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included in the analysis.||Months||95% Confidence Interval|Median
172913|NCT00103207|Secondary|Overall Survival|Overall survival is defined as the time from registration to death.|Every week during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included.||Months||95% Confidence Interval|Median
172914|NCT00103207|Primary|Objective Response Rate (Proportion of Patients With Objective Response)|Response was evaluated using RECIST 1.0 criteria. Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed every 8 weeks during treatment; after off-treatment, every 3 months for 2 years and then every 6 months for 3 years|Only eligible and treated patients with confirmed diagnosis are included in this analysis.||Proportion||90% Confidence Interval|Number
172915|NCT00103194|Secondary|Relationship Between Progression-free Survival and EGFR Expression Levels|The association between EGFR (epidermal growth factor receptor) expression levels and the length of time during and after treatment in which a patient is living with a disease that does not get worse.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started treatment.||months||90% Confidence Interval|Median
172916|NCT00103194|Secondary|Progression-free Survival Rate at 2 Years|Proportion of patients who are living with a disease that does not get worse at 2 years from registration based on Kaplan-Meier method.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started treatment.||percentage of participants||90% Confidence Interval|Number
172917|NCT00103194|Secondary|The Change in PSA Slope With GW572016 (Lapatinib)|PSA was evaluated every cycle while on treatment. PSA test results show the level of PSA detected in the blood. These results were reported as nanograms of PSA per milliliter (ng/mL) of blood. PSA slope is the change in PSA level over time. A sharp rise in the PSA level raises the suspicion of cancer and may indicate a fast-growing cancer.|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually, for 5 years|One patient who withdrew from study after receiving 4 days of treatment and did not have any follow-up PSA measurements was excluded from this analysis, so the number of participants analyzed is 34.||log (PSA)/month||Standard Error|Mean
172918|NCT00103194|Primary|Number of Patients With PSA Response, Defined as a 50% or Greater Decline in the Serum PSA Level|"PSA response is defined as either complete response (CR) or partial response (PR) observed at any time during the entire measurement time period.~CR: In patients treated with prior radical prostatectomy, a PSA < 0.2 ng/mL confirmed by a repeat PSA at least one month apart was considered a complete biochemical response. In patients treated with radiation therapy only, a PSA < 1 ng/mL on three separate occasions taken at least one month apart was considered a complete biochemical response.~PR: A reduction in PSA by > 50% from baseline, confirmed by repeat PSA 1 month later."|Assessed every cycle while on treatment; after being off-treatment, assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years|Eligible patients who started protocol treatment||participants|||Number
172919|NCT00103142|Secondary|Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay|CEA-Specific Immune Responders by enzyme-linked immunosorbent spot (ELISpot). The ELISPOT assay is considered positive for a subject if the mean number of spots with CEA exceeds the number of spots with control by a magnitude of 10 and the difference between CEA and control is statistically significant at a level of p=0.05 by the t-test.|13 weeks|||participants|||Number
172920|NCT00103142|Primary|Recurrence-free Survival at 2 Years|Recurrence-free survival for randomized patients receiving dendritic cells (DC) loaded with PANVAC or PANVAC plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) measured from the date of metastasectomy, with relapse defined as documented disease recurrence at any site.|2 years|||participants|||Number
172921|NCT00103012|Primary|Lopinavir Pharmacokinetics When Administered Alone and in Combination With Three Different Herbal Supplements: Ginkgo Biloba, Panax Ginsing, and Echinacea Purpurea.|The outcome measurement for each study arm is the change in lopinavir area under the concentration versus time curve (AUC) after two weeks administration of an herbal preparation (Ginkgo Biloba, Echinacea purpurea, or Panax Ginseng).|2 weeks|Data was analyzed from all subjects who completed a particular sampling period.||mcg*hr/mL||90% Confidence Interval|Geometric Mean
172922|NCT00102804|Secondary|Maximum Improvement Over Baseline in Individual Symptom Scores and Quality of Life Using the LCSS|The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using VAS from 0 (for best outcome) to 100 (for worst outcome). The average symptom burden index (ASBI) was the mean of the 6 symptom-specific items. The LCSS total score was the mean of the 9 items.|Baseline through 30 days post discontinuation of study treatment (up to 39 Months)|Participants who signed the ICF, completed the randomization process, had LCSS data at baseline and at least once postdose are reported according to the treatment arm to which they were randomized.||units on a scale||Standard Deviation|Mean
172923|NCT00102804|Secondary|Number of Participants With Adverse Events (AEs)|Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of serious and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.|Baseline to study completion (up to 41 Months)|Participants who signed the ICF, completed the randomized process and received at least 1 dose of study drug are reported according to the treatment to which they were received.||participants|||Number
172924|NCT00102804|Secondary|Percentage of Participants With a Complete Response (CR) or Partial Response (PR) (Objective Tumor Response Rate)|Response was defined using RECIST v1.0 criteria. CR was defined as the disappearance of all target lesions. PR was defined either A) at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LDs or B) complete disappearance of target lesions, with persistence (but not worsening) of 1 or more nontarget lesions. In either case, no new lesions may have appeared. The percentage of participants with CR or PR=(Number of participants with CR or PR)/(Number of participants assessed)*100.|Baseline to measured PD (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized.||percentage of participants||95% Confidence Interval|Number
172925|NCT00102804|Secondary|Time to Worsening of Symptoms (TWS)|TWS was the elapsed time from the date of randomization to the first date of worsening [defined as a 15-millimeter (mm) increase from baseline based on a 100-mm scale] of each symptom and summary item in the Lung Cancer Symptom Scale (LCSS). The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant (pt) responses to each item were measured using visual analogue scales (VAS) from 0 (for best outcome) to 100 (for worst outcome). TWS was censored at the date of the last LCSS assessment for pts who were not known to have LCSS worsening.|Randomization to worsening of each LCSS item (up to 39 months)|Pts who signed ICF and completed randomization, according to treatment randomized. Pts censored: Loss of appetite 236,140; fatigue 237,130; cough 274,146; dyspnea 271,143, hemoptysis 404,198; pain 271,135; symptom distress 247,141; interference with activity level 267,141, global quality of life 262,137 pts in pemetrexed, placebo arm, respectively.||months||95% Confidence Interval|Median
172926|NCT00102804|Secondary|Time to Objective Progressive Disease (TPD)|TPD was the elapsed time from the date of randomization to the first date of objective PD. TPD was censored at the date of the participant’s last tumor assessment for participants who were not known to have PD as of the data-inclusion cut-off date for analysis or who died without objective PD. PD, defined using RECIST v1.0, was at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization to measured PD (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 145, 40 participants in the pemetrexed and placebo treatment arms, respectively.||months||95% Confidence Interval|Median
172927|NCT00102804|Secondary|Overall Survival (OS) Time|OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.|Randomization to date of death from any cause (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 138, 48 participants in the pemetrexed and placebo treatment arms, respectively.||months||95% Confidence Interval|Median
172928|NCT00102804|Primary|Progression-Free Survival (PFS) Time|PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant’s last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions.|Randomization to measured PD or death from any cause (up to 41 months)|Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 123, 36 participants in the pemetrexed and placebo treatment arms, respectively.||months||95% Confidence Interval|Median
172929|NCT00102687|Secondary|Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Maintenance Study Period|Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Maintenance study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).|24 months|Intent to treat population||infections per cycle||Full Range|Median
172930|NCT00102687|Secondary|Change From Baseline in the Number of Infections Requiring Treatment With IV Antibiotics Per Treatment Cycle (28 Days) for the Initial Study Period|Baseline uses the average number of infections requiring IV antibiotic treatment from the 28 days prior to and including the day of first dose to an initial treatment arm. Initial study period values total the number of infections requiring IV antibiotic treatment divided by the number of treatment cycles (each cycle is approximately one month).|6 months|Intent to treat population||infections per cycle||Full Range|Median
172931|NCT00102687|Secondary|Platelet Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)|Shift table comparing the platelet transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.|24 months|Intent to treat population||participants|||Number
172932|NCT00102687|Secondary|Red Blood Cell (RBC) Transfusion Status at Baseline and End of Maintenance Study Period (24 Months)|Shift table comparing the RBC transfusion status of patients at the end of the maintenance study period to the transfusion status at baseline.|24 months|Intent to treat population||participants|||Number
172933|NCT00102687|Secondary|Platelet Transfusion Status at Baseline and End of Initial Study Period (6 Months)|Shift table comparing the platelet transfusion status of patients at the end of the initial study period to the transfusion status at baseline.|6 months|Intent to treat population||participants|||Number
172934|NCT00102687|Secondary|Red Blood Cell (RBC) Transfusion Status at Baseline and End of Initial Study Period (6 Months)|Shift table comparing the RBC transfusion status of patients at the end of the initial study period to the transfusion status at baseline.|6 months|Intent to treat population||participants|||Number
172935|NCT00102687|Secondary|Change From Baseline in Absolute Neutrophil Count (ANC) at the End of the Maintenance Study Period (Month 24)|The difference between ANC values at the end of the maintenance study period minus the ANC values at baseline.|24 months|Intent to treat population||x10^9/L||Full Range|Median
172940|NCT00102687|Secondary|Baseline Platelet Values|The median values for platelets based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for platelets. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population||x10(9)/L||Full Range|Median
172941|NCT00102687|Secondary|Change From Baseline in Hemoglobin at the End of the Maintenance Study Period|The difference between hemoglobin values at the end of the maintenance study period minus the hemoglobin values at baseline.|24 months|Intent to treat population||g/L||Full Range|Median
172942|NCT00102687|Primary|Number of Participants Who Improved or Maintained The Hematologic Response From the Initial Study Period (Based on IWG 2000 Criteria For MDS) During the Maintenance Period|Hematologic response during the maintenance period are compared to the response in the initial study period. Initial response could have been a complete remission, a partial remission, stable disease or a hematologic improvement. Maintenance period best response is after randomization to a maintenance arm for those randomized, and is after the start of cycle 7 for those remaining on initial period treatment throughout the study.|24 months|Intent to treat population.||participants|||Number
172943|NCT00102687|Secondary|Change From Baseline in Hemoglobin at End of Initial Study Period (6 Months)|The difference between hemoglobin values at the end of the initial study period minus the hemoglobin values at baseline.|6 months|Intent to treat population||g/L||Full Range|Median
172944|NCT00102687|Secondary|Baseline Hemoglobin Values|The median values for hemoglobin based on blood tests performed on study day 1 (prior to study treatment) constitute a baseline measure for hemoglobin. Baseline values are used to compare to values following treatment.|Day 1 (randomization)|Intent to treat population||g/L||Full Range|Median
172945|NCT00102687|Primary|Number of Participants With Overall Best Hematologic Response and Hematologic Improvement Based on IWG 2000 Criteria For MDS During the Initial Study Period|Number of participants whose best hematological outcome was either complete remission (CR), partial remission (PR) (as determined by the investigator), or any hematologic improvement (based on the IWG 2000 criteria for MDS). See previous outcomes for detailed definitions.|Day 1 (randomization) to 6 months|Intent to treat population||participants|||Number
172946|NCT00102687|Primary|Number of Participants With Best Hematological Improvement Derived Using International Working Group 2000 (IWG 2000) Criteria for MDS During the Initial Study Period.|"IWG 2000 Criteria: Pretreatment=hemoglobin <110g/L or RBC transfusion-dependence, platelet count <100x10^9/L or platelet transfusion dependence, absolute neutrophil count <1.5x10^9/L.~Erythroid response: Major->20g/L increase in hemoglobin or transfusion independence. Minor- 10-20g/L increase in hemoglobin or >=50% decrease in transfusion requirements.~Platelet response: Major-absolute increase of platelet count by >=30x10^9/L or platelet transfusion independence. Minor->=50% increase in platelet count with net increase >10x10^9/L but <30x10^9/L.~(continued in Population Description)"|Day 1 (randomization) to 6 months|"Intent to treat population. Patients count only once for best response within an improvement category.~(Outcome Description continued) Neutrophil response: Major->=100% increase in neutrophil count or an absolute increase of >0.5x10^9/L. Minor->=100% increase but an absolute increase of <0.5x10^9/L."||participants|||Number
172947|NCT00102687|Primary|Number of Participants In Best Hematological Response Categories as Determined by the Investigator Using International Working Group 2000 (IWG 2000) Criteria For Myelodysplastic Syndromes (MDS) During the Initial Study Period.|"Participant counts by best hematological response; complete remission(CR) is better than a partial remission(PR) which is better than stable disease(SD).~Investigator determined responses followed IWG 2000 criteria for MDS CR: repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia PR is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment (see Population Descrip)"|Day 1 (randomization) to 6 months|"Intent to treat population. Patients without a second bone marrow assessment could not be evaluated for hematologic response.~(Outcome Description continued)SD is a failure to achieve at least a PR, but with no evidence of progression for at least 2 months."||participants|||Number
172948|NCT00102596|Secondary|PR and QTc Intervals Post 1-Octanol Dose||0 minutes, 15 minutes, 100 minutes and 24 hours post-dose|All participants who received at least 1 dose of 1-octanol in Part A, B or C||ms||Standard Error|Least Squares Mean
172949|NCT00102596|Secondary|Heart Rate Post 1-Octanol Dose||0 minutes, 15 minutes, 100 minutes and 24 hours post-dose|All participants who received at least 1 dose of 1-octanol in Part A, B or C||beats per minute||Standard Error|Least Squares Mean
172950|NCT00102596|Secondary|Blood Plasma Levels of Octanoic Acid After 64 mg/kg 1-Octanol Dose|Octanoic Acid is a metabolite of 1-octanol. Blood plasma levels of octanoic acid were measured at 5, 20, 45, 70, 100, 130, 160, 210, 270 and 360 minutes post-dose.|5, 20, 45, 70, 100, 130, 160, 210, 270 and 360 minutes post-dose|All participants who received either formulation 64 mg/kg 1-octanol in Part A or B||ng/ml||Standard Deviation|Mean
172951|NCT00102596|Primary|Normalized Mean Tremor Amplitude for Both Formulations of 64 mg/kg 1-Octanol in Part B|Spirography mean tremor amplitudes were measured in the right hand of each participant at 0, 15, 30, 60, 90, 120, 150, 180, 240 and 360 minutes post-dose. Then, the scores of each participant were normalized (i.e., divided by) by their baseline tremor severity scores so that all scores are expressed as a proportion of the baseline score. Therefore, 1 is the baseline tremor severity, and lower scores indicate tremor reduction.|0, 15, 30, 60, 90, 120, 150, 180, 240 and 360 minutes post-dose|All participants who received both formulations of 64 mg/kg 1-octanol in Part B||normalized score on a scale||Standard Error|Mean
172952|NCT00102518|Secondary|Change in Young Mania Rating Scale (Y-MRS) Total Score|"Change from baseline to last scheduled post-baseline evaluation in YMRS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).~The Y-MRS consists of 11 items assessing the core symptoms of mania. Each item has 5 grades of severity. Minimum score on the scale is 0 (absent or normal). Maximum score on the scale is 60 (worse outcome or more severe symptoms)."|Baseline and Week 26|||points||Standard Deviation|Mean
172953|NCT00102518|Secondary|Change in Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change from baseline to the last scheduled post-baseline evaluation in PANSS total score, using observed cases (assessments performed at baseline and weeks 4, 12, and 26).~This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome."|Baseline and Week 26|||points||Standard Deviation|Mean
172954|NCT00102518|Primary|Percentage of Subjects Experiencing SAEs|Percentage of Subjects Experiencing SAEs. The incidences of SAEs are summarized by system organ class in CT-8.5.1; by system organ class and MedDRA preferred term and by system organ class, MedDRA preferred term, and severity.|Baseline and Week 23|All enrolled subjects.||percentage of participants|||Number
172955|NCT00101816|Secondary|Population PK of Dasatinib|Population pharmacokinetic analysis was not done because it is not meaningful for this single study|Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.|||population pk|||Number
172956|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||hours||Standard Deviation|Mean
172957|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||hours||Standard Deviation|Mean
172958|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h (AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were less than the lower limit of quantitation (LLQ) were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng∙h/mL||Standard Deviation|Mean
172959|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib's Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 & Day 8; parameters for 1 participant on Day 1 & 1 on Day 8 were excluded due to unreliable data. Participants w/all concentration-time values <than limit of quantitation were treated as missing for PK analysis. n=participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng/mL||Standard Deviation|Mean
172960|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||hours||Standard Deviation|Mean
172961|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||hours||Standard Deviation|Mean
172962|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 h or 24 h(AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were < lower limit of qualtitation were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng∙h/mL||Standard Deviation|Mean
172963|NCT00101816|Secondary|Pharmacokinetics (PK) of Dasatinib - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|26 participants had dense PK sampling on Day 1 and Day 8; parameters for 1 participant on Day 8 was excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng/mL||Standard Deviation|Mean
172964|NCT00101816|Secondary|Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), AEs Leading to Discontinuation, Drug-Related AEs|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously throughout study, from pre-treatment visit through end of study (due to death, unacceptable toxicity, treatment failure, etc) and follow-up period|All treated subjects||Participants|||Number
172965|NCT00101816|Secondary|Minimally Significant Changes From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)|Number of subjects with minimally significant changes from baseline in the health-related quality of life questionnaire FACT-G. FACT-G=27 questions in 4 domains: physical, social/family, emotional, & functional well-being (PWB, SWB, EWB, FWB). Score range: 0-108; higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, & SWB score change of 2 or more=minimal clinical important change.|Baseline, Every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up|Number of participants with FACT-G assessments at baseline and at least one assessment during treatment||Participants|||Number
172966|NCT00101816|Secondary|MaHR and Major Cytogenetic Response (MCyR) Among Participants With Baseline BCR-ABL Point Mutations|MaHR and MCyR in subjects with mutations at baseline, including imatinib-resistant mutations (IRM) and specific BCR-ABL mutations (SBAM). Criteria for MaHR are specified in Outcome Measure 2. MCyR=rate of complete cytogenetic responses + the rate of partial cytogenetic responses, as defined in Outcome Measure 5. BCR-ABL=the fused gene found in subjects with this type of CML. This table contains those mutations observed in at least 3 participants. The categories “1 IRM w/2-4-fold increase in resistance” and “≥1 IRM w/≥5-fold increase in resistance” refer to increase in resistance to imatinib.|baseline, at time of disease progression|All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 103 of the 109 subjects (10/10 imatinib-intolerant and 93/99 imatinib-resistant). At baseline, 39 (42%) imatinib-resistant subjects and 3 imatinib-intolerant subject had imatinib-resistant mutations||Percentage of Participants|||Number
172967|NCT00101816|Secondary|Number of Participants Achieving Major Molecular Response (MMR)|Number of participants who achieved an MMR at any time during the treatment period. MMR was calulated by measuring BCR-ABL transcripts in blood during treatment using quantitative reverse transcription-polymerase chain reaction (RT-PCR). BCR-ABL=the fused gene found in subjects with this type of Chronic Myeloid Leukemia (CML).|Baseline, every 12 weeks, and at time of Complete Cytogenetic Response (CCyR) for quantitative Polyermase Chain Reaction (qPCR) analysis|treated participants with or without CCyR who were assessed for major molecular response||participants|||Number
172968|NCT00101816|Secondary|Number of Participants With CHR or NEL, MiHR, or no Hematologic Response|Best confirmed hematologic response. Confirmed hematologic response=response that is confirmed after at least 4 weeks with no concomitant use of anagrelide or hydroxyurea use during this interval. Criteria for complete hematologic response (CHR) or No Evidence of Leukemia (NEL) are specified in Outcome Measure 2. Criteria for minor hematologic response (MiHR) are specified in Outcome Measure 1.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycles 1 and 2; After every 2nd cycle for Cycles 3+; at end of treatment|All treated subjects||Participants|||Number
172969|NCT00101816|Secondary|Number of Participants With Complete, Partial, Minor, Minimal, or No Cytogenetic Response|Best confirmed cytogenetic response. Determination of cytogenetic response is based on the prevalence (percentage) of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase in a bone marrow sample (aspirates/biopsies).|Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment|All treated subjects||Participants|||Number
172970|NCT00101816|Secondary|Time to MaHR and OHR|Median time from first dosing to date of OHR and/or MaHR in subjects who achieved OHR and MaHR. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Criteria for MaHR are specified in Outcome Measure 2. Criteria for MiHR are specified in Outcome Measure 1.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved OHR and MaHR||days||95% Confidence Interval|Median
172971|NCT00101816|Secondary|Median Duration of Overall Hematologic Response (OHR)|OHR=best confirmed response of MaHR or MiHR. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR are specified in Outcome Measure 2. Criteria for MiHR are specified in Outcome Measure 1. Maintaining a response was defined as no 2 consecutive records of non-response (ie, a single record of non-response between 2 assessments of response was not considered a loss of response).|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved OHR||months||95% Confidence Interval|Median
172986|NCT00101686|Secondary|Time to Progression: FOLFIRI, mIFL and CapeIRI|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT Population.||months||95% Confidence Interval|Median
172972|NCT00101816|Secondary|Median Duration of Major Hematologic Response (MaHR)|MaHR=best confirmed response of CHR or NEL. CHR=white blood cells ≤ institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤ iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement; at least 1 of the following: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|Participants who achieved MaHR||months||Full Range|Median
172973|NCT00101816|Primary|Major and Overall Hematologic Response (MaHR and OHR)|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR are specified in Outcome Measure 2. OHR=best confirmed response of MaHR or minor HR (MiHR). MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts + promyelocytes in bone marrow and <30% blasts + promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during Cycle 1 and 2; After every 2nd cycle during Cycles 3+; at end of treatment|All treated subjects||Participants|||Number
172974|NCT00101686|Secondary|Overall Relative Dose Intensity of Irinotecan|Relative dose intensity for a cycle was calculated as the percentage of the actual dose intensity of the cycle divided by the planned dose intensity of the cycle. Overall relative dose intensity was calculated as the average relative dose intensities over all cycles. (Dose intensity for each cycle was calculated as the actual dose level of the study medication received in that cycle divided by the number of weeks in the cycle.)|End of treatment cycle|As-Treated population||percent dose intensity||Standard Error|Mean
172975|NCT00101686|Secondary|Dose Reduction Due to Treatment Emergent Adverse Events|Number of subjects that had at least one Treatment-Emergent Adverse Event (TEAE) that led to a dose reduction. TEAE includes all reported Adverse Events that occurred within 30 days of last study medication.|Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI|As-Treated population - all subjects who received any study medication, with treatment assignments designated according to actual study treatment received.||participants|||Number
172976|NCT00101686|Secondary|Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive. Zero subjects analyzed indicates median could not be analyzed based on number of subjects who died.|Last Follow-Up Visit|ITT Population.||months||95% Confidence Interval|Median
172977|NCT00101686|Secondary|1 Year Survival: Bevacizumab With FOLFIRI, mIFL|Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|1 year from date of randomization|ITT Population.||participants|||Number
172978|NCT00101686|Secondary|Overall Response: Bevacizumab With FOLFIRI, mIFL|A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT population.||participants|||Number
172979|NCT00101686|Secondary|Time to Progression: Bevacizumab With FOLFIRI, mIFL|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT population.||months||95% Confidence Interval|Median
172980|NCT00101686|Secondary|Survival Time: Celecoxib and Placebo|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|assessed at least every week during treatment and at least every 3 months during follow-up|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).||months||95% Confidence Interval|Median
172981|NCT00101686|Secondary|Overall Response: Celecoxib and Placebo|A subject will be considered achieving an overall response if the subject has a sustained CR or PR for at least 4 weeks, confirmed by tumor assessments. (Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): ≥ 30% decrease in the sum of the LD of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).||participants|||Number
172982|NCT00101686|Secondary|Time to Progression : Celecoxib and Placebo|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|ITT Population. Celecoxib participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab); Placebo participants were combined from FOLFIRI, mIRI, and Capecitabine treatments (not bevacizumab).||months||95% Confidence Interval|Median
172983|NCT00101686|Secondary|1 Year Survival: FOLFIRI, mIFL and CapeIRI|Number of patients alive or dead at 1 year. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|1 year from date of randomization|ITT Population.||participants|||Number
172984|NCT00101686|Secondary|Survival Time: FOLFIRI, mIFL and CapeIRI|Survival time defined as time from date of randomization to date of death. In the absence of confirmation of death, survival time was censored to last date the subject known to be alive.|assessed at least every week during treatment and at least every 3 months during follow-up|ITT Population.||months||95% Confidence Interval|Median
172985|NCT00101686|Secondary|Overall Response: FOLFIRI, mIFL and CapeIRI|A subject will be considered achieving an overall response if the subject has a sustained Complete Response (CR) or Partial Response (PR) for at least 4 weeks, confirmed by tumor assessments. (CR: Disappearance of all target lesions. PR: greater than or equal to 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the Pre-treatment sum LD. )|every 6 weeks during chemotherapy until disease progression|ITT Population.||participants|||Number
172987|NCT00101686|Primary|Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL|Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).|every 6 weeks until disease progression|Intent-to-Treat Population (ITT) - all subjects who were randomized, with study drug assignment designated according to initial randomization, regardless of whether subjects received any study drug or received a different drug from that to which they were randomized.||months||95% Confidence Interval|Median
172988|NCT00101660|Secondary|Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib|Blood samples were collected for PK to be included in separate population PK analyses.|Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose.|No study-specific PK analyses were planned for this report.||Participants|||Number
172989|NCT00101660|Secondary|Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE|AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously, from baseline through 2 years|All imitanib-resistant participants who received treatment.||Participants|||Number
172990|NCT00101660|Secondary|Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE|AE=any new untoward medical occurrence or worsening of a preexisting medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuously, from baseline through 2 years|All imitanib-intolerant participants who received treatment.||Participants|||Number
172991|NCT00101660|Secondary|Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores|Health-related quality of life as measured by FACT-G, which comprises 27 questions in 4 domains: PWB, SWB, EWB, FWB. Total FACT-G score=summation of the 4 subscale scores and ranges from 0 to 108. Higher scores=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, & FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinical important change. Baseline FACT-G measurements can be found in Baseline Characteristics.|Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.|Number of participants with assessments at baseline and timepoint||Participants|||Number
172992|NCT00101660|Secondary|Number of Participants With Major Molecular Response (MMR)|MMR is defined as ≤3 log reduction in BCR-ABL levels from the standardized baseline value of BCR-ABL:Control Gene ratio. The international ratio is obtained by multiplying BCR-ABL:Control gene ratio by the lab-specific conversion factor.|Baseline to 2 years|All participants who received treatment.||Participants|||Number
172993|NCT00101660|Secondary|Median Time From First Dosing Until CHR|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study|Population limited to responders (those achieving CHR) only||Months||Full Range|Median
172994|NCT00101660|Secondary|Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months|Based on the Kaplan-Meier estimate of the duration of response. CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets < 450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|12 and 24 months|Population limited to responders (those achieving CHR) only||Percentage of participants|||Number
172995|NCT00101660|Secondary|Number of Participants With Complete Hematologic Response (CHR)|CHR=all of the following criteria: white blood cell count ≤ institutional upper limit of normal; platelets <450,000/mm^3; no blasts or promyelocytes in peripheral blood; <5% myelocytes plus metamyelocytes in peripheral blood; peripheral blood basophils ≤20%; no extramedullary involvement. Response, as defined, must be maintained for at least 4 weeks after first documented. A CHR could begin only 14 days after dosing start date.|Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study|All participants who received treatment.||Participants|||Number
172996|NCT00101660|Secondary|Median Time From First Dosing Date to Date of MCyR|MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.|Baseline (within 4 weeks of Day 1) and every 12 weeks|Population is limited to responders (those who acheived MCyR) only||Months||Full Range|Median
172997|NCT00101660|Secondary|Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months|Based on the Kaplan-Meier estimate of the duration of response. Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases and Partial Cytogenetic Response (PCyR) - 1% to 35% Ph+ metaphases.|12 and 24 Months|Population is limited to responders (those who acheived MCyR) who were also assessed for duration of MCyR.||Percentage of participants|||Number
172998|NCT00101660|Secondary|Number of Imatinib-intolerant Participants With MCyR|Determination of cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of CCyR-0% Ph+ metaphases and PCyR - 1% to 35% Ph+ metaphases.|Baseline to 2 years|All imatinib-intolerant participants who received treatment.||Participants|||Number
172999|NCT00101660|Primary|Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)|Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.|2 years|All imatinib-resistant participants who received treatment.||Participants|||Number
173000|NCT00101647|Secondary|Population PK of Dasatinib|Population pharmacokinetic analysis was not done because it is not meaningful for this single study|Day 8 immediately prior to the first daily dose and between 30 minutes to 3 hours following this dose.|||Population PK analysis|||Number
173001|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Plasma Half-life (T-HALF)|The T-HALF was calculated as Ln2/Lz,where Lz was the absolute value of the slope of the terminal log-linear phase.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||hours||Standard Deviation|Mean
173002|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Time to Maximum Observed Plasma Concentration (Tmax)|The Tmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|A total of 29 participants had dense PK sampling on both Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable concentration-time profiles. n=the number of participants on Day 1 and Day 8 who were included in the statistical analyses of PK parameters.||hours||Standard Deviation|Mean
173003|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Time Point Within the Dosing Interval of 12 Hours (AUC[0-T])|The AUC(0-T) was calculated using the mixed log-linear trapezoidal algorithm in Kinetica™. In the calculation of AUC(0-T), predose concentrations that were less than the lower limit of quantitation (LLQ) were assigned a value of zero.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng∙h/mL||Standard Deviation|Mean
173004|NCT00101647|Secondary|Pharmacokinetics (PK) of Dasatinib and Its Metabolite BMS-582691 - Maximum Observed Plasma Concentration (Cmax)|The Cmax was obtained from experimental observations. Using no weighting factor, the terminal log-linear phase of the concentration-time curve was identified by least-square linear regression of at least 3 data points that yielded a maximum G-criteria,which is also referred to as adjusted R-squared.|Collected on Days 1 and 8 at times as close as possible to the following time points (relative to drug administration): pre-dose, and following drug administration at 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8 and 10 hours.|29 participants had dense PK sampling on Day 1 and Day 8; parameters for 2 participants on Day 8 were excluded due to unreliable data. Participants with all concentration-time values < than the limit of quantitation were treated as missing for PK analysis. n= participants included in the statistical analyses of PK on Day 1 and Day 8, respectively.||ng/mL||Standard Deviation|Mean
173005|NCT00101647|Secondary|Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, Hematologic Toxicities, and Toxicities Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition regardless of causal relationship with treatment. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires or prolongs inpatient hospitalization; results in persistent or significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Graded by National Cancer Institute Common Terminology Criteria for Adverse Events v3.0. (1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death)|Continuous from pretreatment through each 4-week cycle and at follow-up. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|||Participants|||Number
173006|NCT00101647|Secondary|Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G)|Number of subjects with minimally significant changes from baseline in the health-related quality of life questionnaire FACT-G. FACT-G=27 questions in 4 domains: physical, social/family, emotional, and functional well-being (PWB, SWB, EWB, FWB). Total score=0 to 108; higher score=better health-related quality of life. Total Score change of 7 or more=minimal clinical important change; PWB, EWB, and FWB score change of 3 or more, and SWB score change of 2 or more=minimal clinically important change.|Baseline, every 2 weeks for the first 3 cycles, following every 4-week cycle, and once at follow-up.(treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|Number of participants with FACT-G assessments at baseline and at least one assessment during treatment||Participants|||Number
173040|NCT00102063|Other Pre-specified|Change in Pediatric Quality of Life Enjoyment and Satisfaction (PQLES) Questionnaire Total Score|"Change from baseline to last observed post-baseline value in PQLES total score, using the last observation carried forward.~Scale consists of 14 items pertaining to daily life activities and satisfaction, and an overall assessment item. Each item will be rated on a five-point scale (1=very poor, 2=poor, 3=fair, 4=good, 5=very good) with a minimum score of 14 (better outcome) and a maximum score of 70 (worse outcome)."|Baseline and Day 42|||points||Standard Error|Mean
173007|NCT00101647|Secondary|MaHR and MCyR Among Participants With Baseline BCR-ABL Point Mutations|Major hematologic and cytogenetic responses (MaHR and MCyR) to dasatinib in subjects with mutations at baseline, including imatinib-resistant mutations (IRM) and specific BCR-ABL mutations (SBAM). BCR-ABL=the fused gene found in subjects with this type of CML. Criteria for MaHR are specified in Outcome Measure 2. MCyR=combined complete cytogenetic and partial cytogenetic response rate. Complete Cytogenetic Response= 0% Ph+ Cells in Metaphase in Bone Marrow, Partial Cytogenetic Response > 0% to 35% Ph+ Cells in Metaphase in Bone Marrow.|Baseline, at time of disease progression. (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|All subjects with baseline mutation data; n=the number of participants with the specified mutation. Baseline mutation data were reported for 162 of the 174 subjects (12/13 imatinib-intolerant and 150/161 imatinib-resistant). At baseline, 89 (59%) imatinib-resistant subjects and 1 imatinib-intolerant subject expressed imatinib resistant mutations.||Percentage of participants|||Number
173008|NCT00101647|Secondary|Number of Participants Who Achieved a Major Molecular Response (MMR) During Treatment Period|Number of participants who achieved an MMR at any time during the treatment period. MMR was calculated by measuring BCR-ABL transcripts in blood during treatment using quantitative reverse transcription-polymerase chain reaction (RT-PCR). BCR-ABL=the fused gene found in subjects with this type of Chronic Myeloid Leukemia (CML).|Baseline, every 12 weeks throughout study (treatment continued until discontinuation due to toxicity, disease progression, or other protocol-specified criteria).|Number of Participants Analyzed=all treated subjects who were assessed for major molecular response; n=participants with or without CCyR in cohort.||participants|||Number
173009|NCT00101647|Secondary|Best Confirmed Hematologic Response|Number of participants with confirmed complete hematologic response (CHR) or No Evidence of Leukemia (NEL), minor hematologic response (MiHR), or no hematologic response. Confirmed hematologic response=response that is confirmed after at least 4 weeks with no concomitant use of anagrelide or hydroxyurea use during this interval. Criteria for CHR and NEL are specified in Outcome Measure 2; criteria for MiHR are specified in Outcome Measure 4.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|All treated subjects||Participants|||Number
173010|NCT00101647|Secondary|Best Cytogenetic Response|Number of participants with complete, partial, minor, minimal, or no cytogenetic response. Determination of cytogenetic response based on the prevalence (percentage) of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase in a bone marrow sample (aspirates/biopsies).|Baseline (within 4 weeks of therapy start); Every month for Cycles 1-3; Every 12 weeks for Cycles 4+; end of treatment|All treated subjects||Participants|||Number
173011|NCT00101647|Secondary|Time to OHR|Median time (in months) from first dosing date to date of OHR. OHR=best confirmed response of MaHR or MiHR. Criteria for MaHR specified in Outcome Measure 2. MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts+promyelocytes in bone marrow and <30% blasts+promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response = response confirmed ≥4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|Population comprised of responders only||days||Full Range|Median
173012|NCT00101647|Secondary|Median Time in Days From First Dosing Date to Date of MaHR|MaHR=best response of CHR or NEL. CHR=white blood cells ≤institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤iULN; no extramedullary involvement; at least 1 of: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|Population is comprised of responders only||Days||Full Range|Median
173013|NCT00101647|Secondary|Percentage of Participants Who Achieved OHR and Did Not Progress at 12 Months and 24 Months|Percentage of participants who achieved OHR and did not progress at specified timepoints, based on the Kaplan-Meier estimate of the duration of response. OHR=best confirmed response of MaHR or MiHR. MaHR criteria in Outcome Measure 2. MiHR= <15% blasts in bone marrow and <15% blasts in peripheral blood (PB); <30% blasts+promyelocytes in bone marrow and <30% blasts+promyelocytes in PB; <20% basophils in PB; no extramedullary disease other than spleen and liver. Confirmed hematologic response= confirmed ≥4 weeks after 1st documented event with no concomitant use of anagrelide or hydroxyurea.|12 months, 24 months|Population is comprised of responders only||Percentage of responders|||Number
173014|NCT00101647|Secondary|Percentage of Participants Who Achieved MaHR and Did Not Progress at 24 Months in the Imatinib-Resistant Group (Based on the Kaplan-Meier Estimate of the Duration of Response)|Percentage of participants in the Imatinib-Resistant Group who achieved MaHR and did not progress at Month 24, based on the Kaplan-Meier estimate of the duration of response. MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). Criteria for MaHR and NEL are specified in Outcome Measure 2.|24 months|Population comprised of responders only. NOTE: Projected duration of MaHR at 24 months in the Imatinib-Intolerant group was beyond the maximum observed time for this cohort, and therefore only the Imatinib-Resistant group is presented.||percentage of responders|||Number
173015|NCT00101647|Secondary|Percentage of Participants Who Achieved MaHR and Did Not Progress at 12 Months (Based on the Kaplan-Meier Estimate of the Duration of Response)|MaHR=best response of CHR or NEL. CHR=white blood cells ≤institutional upper limit of normal (iULN); absolute neutrophil count (ANC) ≥1000/mm3; platelets ≥100,000/mm3; no blasts/promyelocytes in peripheral blood (PB); bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤ iULN; no extramedullary involvement. NEL=WBC ≤iULN; no blasts/promyelocytes in PB; bone marrow blasts ≤5%; <5% myelocytes+metamyelocytes in PB; PB basophils ≤iULN; no extramedullary involvement; at least 1 of: ANC ≥500/mm3 & <1000/mm3; platelets ≥20,000/mm3 & <100,000/mm3.|12 months|Population comprised of responders only.||percentage of responders|||Number
173041|NCT00102063|Secondary|Change in Children’s Global Assessment Scale (CGAS) Score|"Change from baseline to last observed post-baseline value in CGAS score, using the last observation carried forward.~Scale is a 100-point scale measuring psychological, social, and school functioning for children aged 6 to 17 years. Minimum scores ranged from 1-10, representing the need for constant supervision (worse outcome) to maximum scores of 91-100, representing superior functioning (better outcome)."|Baseline and Day 42|||points||Standard Error|Mean
173016|NCT00101647|Primary|Major and Overall Hematologic Response (MaHR and OHR)|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL). OHR=best confirmed response of MaHR or minor hematologic response (MiHR). Confirmed hematologic response=response confirmed ≥4 weeks after first documented event with no concomitant use of anagrelide or hydroxyurea. Maintaining a response=no 2 consecutive records of nonresponse at assessment. Criteria for CHR and NEL specified in Outcome Measure 2 and criteria for MiHR in Outcome Measure 4.|Baseline (within 72 hours of therapy start); Cycle 1/Day 1; Weekly during treatment; at end of treatment|All treated subjects||participants|||Number
173017|NCT00101582|Secondary|Number of Participants With Unplanned Breaks in Radiotherapy|Participants with a duration of 5 days or more without an administration of radiotherapy or who discontinue radiotherapy prior to completion of planned radiotherapy were considered to have an unplanned break in radiotherapy.|During the 7 weeks of radiotherapy|Full analysis set||participants|||Number
173018|NCT00101582|Secondary|Number of Participants With Unplanned Breaks in Cisplatin Chemotherapy Treatment|Cisplatin was administered on Days 1, 22, and 43. An unplanned break in cisplatin refers to a delay of ≥ 5 days from the scheduled Day 22 or Day 43 cisplatin administration or a discontinuation of cisplatin for any reason.|During the 7 weeks of chemotherapy treatment|Full analysis set||participants|||Number
173019|NCT00101582|Secondary|Total Dose of Opioid Analgesics Used for Mucositis Within 15 Weeks|"The total dose of opioid analgesics (mg of intravenous [IV] morphine equivalents) used by all participants.~Participants with at least one reported administration of opioid analgesic (parenteral, peroral or transdermal) were considered to have received opioid analgesics. The total dose of opioid analgesics is the sum of all opioid analgesic administrations that have been converted to morphine equivalents."|Up to 15 weeks|Full analysis set||mg of IV morphine equivalents||Standard Deviation|Mean
173020|NCT00101582|Secondary|Patient-Reported Mouth and Throat Soreness Score|"The average patient-reported mouth and throat soreness (MTS) score as reported on question 3 of the Oral Mucositis Weekly Questionnaire for Head and Neck Cancer [OMWQ-HN]): How much mouth and throat soreness did you experience in the past 24 hours? Participants answered on a scale from 0 (no soreness) to 4 (extreme soreness).~For each participant, an average patient-reported mouth and throat soreness score was calculated by dividing the sum of the MTS scores at each assessment by the total number of assessments."|Assessed twice a week for up to 15 weeks.|"The Patient Reported Outcome-evaluable analysis set included all randomized patients with a valid Baseline assessment for MTS question 3 of the OMWQ-HN and either:~At least 1 completed assessment each week for MTS up to withdrawal/Week 8, whichever came first, or~70% or greater overall compliance for MTS until withdrawal/Week 8."||units on a scale||Standard Deviation|Mean
173021|NCT00101582|Secondary|Number of Participants With Xerostomia at Month 4 (Grade 2 or Higher)|The number of participants with grade 2 or higher xerostomia (dryness of the oral mucosa) at the Month 4 visit, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Dry Mouth/Xerostomia scale.|Month 4|Full Analysis Set||participants|||Number
173022|NCT00101582|Secondary|Time to Onset of Severe (WHO Grade 3 or 4) Oral Mucositis|"Time to onset of severe (WHO Grade 3 or 4) oral mucositis (OM) was analyzed using the Kaplan-Meier procedure.~Participants without an assessed event by the end of the acute OM evaluation phase were censored at the date of last assessment for severe OM."|Up to 15 weeks|Full analysis set||days||Inter-Quartile Range|Median
173023|NCT00101582|Secondary|Duration of Severe (WHO Grade 3 or 4) Oral Mucositis|The duration of severe oral mucositis (OM) was calculated as the number of days from the onset of severe OM (first time a WHO grade 3 or 4 was observed) to the day when severe OM was resolved (first time WHO grade 2 or less was observed after last WHO grade 3 or 4). Durations of 0 days were assigned to those participants who did not experience any WHO grade 3 or 4 during the study.|Up to 15 weeks|Full analysis set||days||Inter-Quartile Range|Median
173024|NCT00101582|Primary|Number of Participants With Severe (Grade 3 or 4) Oral Mucositis|Participants underwent evaluations of oral mucosal (OM) surfaces (mucositis assessments) 2 times weekly throughout radio/chemotherapy, and 2 times weekly thereafter until severe OM returned to grade ≤ 2 or until Week 15. During each evaluation, the following anatomical areas were assessed: upper lip; lower lip; right cheek; left cheek; right ventral & lateral tongue; left ventral & lateral tongue; floor of the mouth; hard palate; soft palate. A trained evaluator documented the findings using the World Health Organization (WHO) oral toxicity scale according to the following: Grade 0 = None; Grade 1 = Soreness, erythema; Grade 2 = Erythema, ulcers, ability to eat solids; Grade 3 = Ulcers, requires liquid diet; Grade 4 = Alimentation not possible.|Up to Week 15|The Full Analysis Set included all randomized participants.||participants|||Number
173025|NCT00102440|Secondary|Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.|The percentage of subjects requiring treatment for a gout flare between Weeks 8 and 52 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.|Weeks 8 through 52|Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 52.||percentage of subjects|||Number
173026|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.|Change in number of tophi/subject calculated for the subset of subjects with palpable tophi at Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.||number of tophi||Inter-Quartile Range|Median
173027|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.|The change from baseline at Week 52 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 52 visit, the total count was assumed to be zero.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.||number of tophi||Inter-Quartile Range|Median
173083|NCT00101400|Secondary|Number of Subjects With Stable Disease up to Cycle 4|Number of subjects who had not responded to treatment but had stable disease up to cycle 4.|Until 30 days after termination of active therapy|Intent to treat population consisting of subjects who received at least 1 dose of sorafenib.||participants|||Number
173028|NCT00102440|Secondary|Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.|The change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 28 visit, the total count was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed.||number of tophi||Inter-Quartile Range|Median
173029|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.||percent change from baseline||Inter-Quartile Range|Median
173030|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 52 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 52 visit, the size was assumed to be zero.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.||percent change from baseline||Inter-Quartile Range|Median
173031|NCT00102440|Secondary|Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.|The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed.||percent change from baseline||Inter-Quartile Range|Median
173032|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Final Visit|The percent change in serum urate from baseline to the Final visit was calculated as [(Final Visit - baseline levels/baseline)]*100 and summarized. The Final visit was the last visit with a serum urate value. The timing of the final visit may have differed for each subject.|Baseline and Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||percent change from baseline||Standard Deviation|Mean
173033|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 52.|Serum urate values were obtained at the Week 52 visit. The percent change in serum urate was calculated as [(week 52 - baseline levels/baseline)]*100 and summarized.|Baseline and Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||percent change from baseline||Standard Deviation|Mean
173034|NCT00102440|Secondary|Percent Change From Baseline in Serum Urate Levels at Week 28.|Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(week 28 - baseline levels/baseline)]*100 and summarized.|Baseline and Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||percent change from baseline||Standard Deviation|Mean
173035|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit|The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject.|Final Visit (up to 52 weeks)|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percentage of subjects|||Number
173036|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit|Serum urate values were obtained at the Week 52 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 52 visit was summarized.|Week 52|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percentage of subjects|||Number
173037|NCT00102440|Secondary|Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit|Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.|Week 28|Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed.||Percentage of subjects|||Number
173038|NCT00102440|Primary|Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)|Each subject’s serum urate at the last 3 visits determined the subject’s response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.|Last 3 Visits (up to 52 weeks)|Analysis was performed on the intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL.||Percentage of subjects|||Number
173039|NCT00102063|Other Pre-specified|Patients Achieving Remission|The number of subjects achieving remission. Remission was defined as a score of mild or less (≤ 3) for items P1, P2, P3, N1, N4, N6, G5, and G9 in the PANSS score.|Baseline and Day 42|||participants|||Number
173042|NCT00102063|Secondary|Clinical Global Impression (CGI) Improvement Score|"Last observed post-baseline value in CGI improvement score, using the last observation carried forward.~Scale refers to the global impression of the subject with respect to improvement of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe)."|Baseline and Day 42|||points||Standard Error|Mean
173043|NCT00102063|Secondary|Change in Clinical Global Impression (CGI) Severity Score|"Change from baseline to last observed post-baseline value in CGI severity score, using the last observation carried forward.~Scale refers to the global impression of the subject with respect to severity of the illness. The scale rates the subject's severity of illness from 0 (not rated) to 1 (least severe) to 7 (most severe)."|Baseline and Day 42|||points||Standard Error|Mean
173044|NCT00102063|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) Negative Subscale Score|"Change from baseline to last observed post-baseline value in PANSS Negative Subscale score, using the last observation carried forward.~Scale consists of 7 negative symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome."|Baseline and Day 42|||points||Standard Error|Mean
173045|NCT00102063|Secondary|Change in Positive and Negative Syndrome Scale (PANSS) Positive Subscale Score|"Change from baseline to last observed post-baseline value in PANSS positive subscale score, using the last observation carried forward.~Scale consists of 7 positive symptom constructs each to be rated on a 7- point scale of severity with 1 = absent to 7 = extreme. Minimum score is 7 which is best outcome; maximum score is 49 for worse outcome."|Baseline and Day 42|||points||Standard Error|Mean
173046|NCT00102063|Primary|Change in Positive and Negative Syndrome Scale (PANSS) Total Score|"Change from baseline to last observed post-baseline value in PANSS total score, using the last observation carried forward.~This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point scale of severity with 1 being absent to 7 being extreme. Minimum score is 30 which is best outcome; maximum score is 210 for worse outcome."|Baseline and Day 42|||points||Standard Error|Mean
173047|NCT00101933|Other Pre-specified|Change in Most Severe Seizures|"Seizures were recorded on daily seizure diaries. The subject recorded the number of seizures by seizure type on the seizure diary. The subject also noted at baseline, of those they had ever experienced, which seizure they considered to be most severe."|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set. In addition, the protocol prespecified that if a subject did not experience the severe seizure in the baseline phase that they would not be included in the calculation of the blinded phase median seizure frequency percentage change from baseline."||Percentage change from baseline||Inter-Quartile Range|Median
173048|NCT00101933|Primary|Alternative Primary Analysis: Change in Seizure Rate|A generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. With one outlier subject removed, the GEE model for this alternative analysis included treatment effect, log of the baseline seizure count, log of age, visit (categorical), and the offset (the number of days the diary was recorded in each month).|Through the end of the three-month blinded phase|"This analysis used the protocol-prespecified Primary analysis data set with one additional outlier subject removed from the active group. This subject had 210 stimulation initiated seizures within 48 hours of the device being turned on and was determined to be an outlier using both a statistical and clinical rationale."||Percentage change from baseline||Inter-Quartile Range|Median
173049|NCT00101933|Secondary|Proportion of Treatment Failures|A treatment failure was defined in the protocol as a subject who 1) required 3 or more doses of rescue medication within 48 hours, 3 times during the blinded phase; or 2) had 3 episodes of convulsive status epilepticus during the blinded phase.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."||participants|||Number
173050|NCT00101933|Secondary|Percentage Change in the Maximum Length of Seizure-free Intervals|Difference between active group and control group in percentage change in the maximum length of seizure-free intervals over the entire blinded phase as compared to the entire baseline phase.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."||Percentage change from baseline||Inter-Quartile Range|Median
173051|NCT00101933|Secondary|Change in Percentage of Days Seizure-free|Difference between active group and control group in percentage change in seizure-free days over the entire blinded phase as compared to the entire baseline phase. The number of seizure-free days was normalized to 84-day baseline and blinded phases for each subject.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. In addition, percentage change was not calculated for subjects who had no seizure-free days during the baseline phase."||Percentage change from baseline||Inter-Quartile Range|Median
173052|NCT00101933|Secondary|Seizure Responder Rate|A responder is defined as a subject with greater than or equal to 50% reduction in seizures as compared with baseline.|Through the end of the three-month blinded phase|"This analysis used the Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."||Number of participants|||Number
173053|NCT00101933|Secondary|Incidence of Sudden Unexplained Death in Epilepsy (SUDEP)|"The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up. The confidence interval is the 95% Poisson confidence interval. Per protocol, only definite and probable SUDEP classifications were included in the calculation.~The results shown are for the entire study follow-up after device implantation."|Inclusive of all study follow-up after device implantation (mean follow-up 3.7 years)|This analysis used all subjects who were implanted and received stimulation. One subject was implanted but was not subsequently randomized, but did receive stimulation. This subject has been included for the purposes of this analysis for a total of 110 subjects included in this analysis.||Number of subjects experiencing SUDEP|||Number
173084|NCT00101400|Secondary|Survival Time|After the end of treatment visit (30 days after the last dose), the subjects were monitored every 3 months for survival (visits/phone calls).|Start of treatment to death|Intent to treat population consisting of subjects who received at least 1 dose of sorafenib.||days||95% Confidence Interval|Median
173054|NCT00101933|Secondary|Adverse Events Experienced With the Medtronic DBS System|"The results are for the follow-up after device implantation through Year 2 and summarized are events that occurred in greater than 5% of subjects. Only events related to the device, therapy, or surgery are included. These abbreviations were used:~General dis...=General disorders and administration site conditions~Injury, poison...=Injury, poisoning and procedural complications~Ther.=Therapeutic.~For this summary, adverse events are reported as 'MedDRA System Organ Class - adverse event'."|Through Year 2 of the long-term follow-up phase|This analysis used all subjects who were implanted and received stimulation. One subject was implanted but was not subsequently randomized, but did receive stimulation. This subject has been included for the purposes of this analysis for a total of 110 subjects, as opposed to the 109 stated in the participant flow.||participants|||Number
173055|NCT00101933|Primary|Primary Analysis: Change in Seizure Rate|A protocol-prespecified generalized estimating equations (GEE) analysis was used to evaluate the treatment effect on seizure frequency. The final GEE model for the primary objective evaluation included treatment effect, log of the baseline seizure count, log of age, visit (categorical), treatment-by-visit interaction (categorical), and the offset (the number of days the diary was recorded in each month).|Through the end of the three-month blinded phase|"This analysis used the protocol-prespecified Primary analysis data set which required that subjects had at least 70 days of diary in the blinded phase. One control subject was not included in this analysis as they had 66 of the required 70 days."||Percentage change from baseline||Inter-Quartile Range|Median
173056|NCT00101907|Primary|Participant Incidence of Adverse Events|The number of participants who experienced at least one treatment-emergent adverse event. Additional details regarding specfic adverse events are provided in the Adverse Event section of this posting.|From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days.|Safety Analysis Set, composed of all participants in the AMG 706 treatment groups who received at least one dose of AMG 706 and all participants in the panitumumab-only treatment group who received at least one dose of panitumumab.||Participants|||Number
173057|NCT00101907|Secondary|AUC0-inf|Area under the concentration-time curve from time 0 to infinite time (AUC0-inf) postdose with AMG 706. AUC0-inf was estimated using the linear/log trapezoidal method. AUC0-inf was not calculated for the BID cohort.|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK analysis set. Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.||μg*hr/mL||Standard Deviation|Mean
173058|NCT00101907|Secondary|AUC0-24|Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC0-24) with AMG 706. AUC0-24 was estimated using the linear/log trapezoidal method. For the BID cohort, AUC0 24 was estimated as 2 times the AUC from time 0 to 12 hours post the first daily dose (AUC0-12) using the linear/log trapezoidal method.|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK Analysis set; Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.||μg*hr/mL||Standard Deviation|Mean
173059|NCT00101907|Secondary|Cmax|The maximum observed plasma concentration after AMG 706 dosing|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|PK analysis set.||ng/mL||Standard Deviation|Mean
173060|NCT00101907|Secondary|Tmax|Time after dosing when maximum plasma concentration was observed for AMG 706|Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.|The Pharmacokinetic (PK) Analysis Set consists of patients who had dosing and PK sampling times recorded on the day of PK sample collection and no significant protocol deviations that impacted the quality of the PK data (for example, sample processing errors and/or inaccurate dosing on the day of the PK sampling).||hours||Full Range|Median
173061|NCT00101907|Secondary|Number of Participants With an Objective Tumor Response|The number of participants with a confirmed objective tumor response, defined as a complete response (CR) or partial response (PR) throughout based on modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Any CR or PR was to be confirmed 4 to 6 weeks after the initial CR or PR.|From enrollment until date of last follow-up visit. The median follow-up time was 24 weeks, with a range of 3 to 73 weeks.|Efficacy Analysis Set, defined as defined as patients who received at least 1 dose of AMG 706 for AMG 706 treatment groups and patients who received at least 1 dose of panitumumab for the panitumumab-only treatment group.||participants|||Number
173062|NCT00101868|Secondary|Physician Time Spent to Complete the Discharge Application||averaged over 2 years of patient enrollment||||||
173063|NCT00101868|Secondary|Number of Emergency Department Visits|Number of participants with at least one emergency department visit within six months after discharge|within 6 months after discharge|intention to treat||participants|||Number
173064|NCT00101868|Secondary|Number of Outpatient Visits||within 6 months after discharge||||||
173065|NCT00101868|Secondary|Discharge Physician Satisfaction With Discharge Process||6 months after using discharge process||||||
173066|NCT00101868|Secondary|Primary Care Physician's Perception, Satisfaction||10 days after discharge||||||
173067|NCT00101868|Secondary|Primary Care Physician's Perception, Effectiveness||10 days after discharge||||||
173068|NCT00101868|Secondary|Patient's Satisfaction With Drug Information||1 week after discharge||||||
173069|NCT00101868|Secondary|At Least One Adverse Event Within One Month After Discharge|Number of participants with at least one adverse event within one month after discharge|1 month after discharge|intention to treat||participants|||Number
173070|NCT00101868|Secondary|Pharmacist's Satisfaction With Discharge Prescription||1 day after discharge||||||
173071|NCT00101868|Secondary|Pharmacist Needed to Clarify the Discharge Prescription||1 day after discharge||||||
173072|NCT00101868|Secondary|Patients' Perception of Discharge Process, Satisfaction||1 week after discharge||||||
173073|NCT00101868|Secondary|Patients' Perception of Discharge Process, Effectiveness, Satisfaction, Preparedness||1 week after discharge||||||
173074|NCT00101868|Primary|Hospital Readmission, at Least One|Number of participants with at least one readmission within 6 months after discharge from index hospital visit|within 6 months after discharge|Analysis was intention to treat. All 631 patient participants assigned to interventions were analyzed||participants|||Number
173085|NCT00101400|Secondary|Overall Response Duration|Overall response duration was defined only for subjects achieving confirmed objective response (PR or CR). It was measured from start of treatment to the date when progressive disease was first objectively documented.|Time from PR or CR to progression|1 subject out of 54 achieved PR.||days|||Number
173075|NCT00101452|Primary|Hamilton Rating Scale for Depression (HAM-D)|The change in total HAM-D score between baseline and endpoint was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on a scale of zero to four and the sum of the scores provides the total score for the measure. Scores can range from 0- 68. On this scale, higher scores indicate poorer outcomes.|baseline and 24 weeks|Based on having at least one post-baseline visit.||units on a scale||Standard Deviation|Mean
173076|NCT00101439|Secondary|Total Cholesterol Concentration of Chylomicron-remnant (Sf 60-400) Subfractions After a Cholesterol-Rich Test Meal|On each of 2 days prior to the last day of each treatment period, participants consumed 2 large eggs in the evening. On the morning of the final day of each treatment period, fasting participants were given a site-prepared, cholesterol-enriched milkshake that provided 1114 calories of total energy (~44% of calories from fat, ~40% of calories from carbohydrate and ~17% of calories from protein) and 504 mg of cholesterol. The milkshake was consumed over a 15-minute period. Plasma samples were collected immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours afterwards for isolation and analysis of lipoprotein subfractions. The geometric mean concentration level was calculated using data obtained at all timepoints.|Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period.|Participants who received at least one dose of study drug and did not have any protocol violations.||mg/dL||Full Range|Geometric Mean
173077|NCT00101439|Primary|Total Cholesterol Concentration of Chylomicron (Sf≥400) Fractions After a Cholesterol-Rich Test Meal|On each of 2 days prior to the last day of each treatment period, participants consumed 2 large eggs in the evening. On the morning of the final day of each treatment period, fasting participants were given a site-prepared, cholesterol-enriched milkshake that provided 1114 calories of total energy (~44% of calories from fat, ~40% of calories from carbohydrate and ~17% of calories from protein) and 504 mg of cholesterol. The milkshake was consumed over a 15-minute period. Plasma samples were collected immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours afterwards for isolation and analysis of lipoprotein fractions. The geometric mean concentration level was calculated using data obtained at all timepoints.|Immediately prior to consumption of the test meal (baseline) and at 2, 3, 4, and 6 hours after test meal on Day 28 of each treatment period.|Participants who received at least one dose of study drug and did not have any protocol violations.||mg/dL||Full Range|Geometric Mean
173078|NCT00101413|Secondary|Change From Baseline of Health-Related Quality of Life (HRQOL) Score Assessed at Cycle 2, Cycle 4, and End of Treatment (EOT)|HRQoL was assessed with the FACT-L questionnaire, a validated instrument for determining lung cancer HRQoL. The 36-item questionnaire includes 4 domains: Physical, functional, emotional, and social/family well-being, and a lung cancer-specific subscale. The FACT-L total score ranges from 1 to 136. Lower scores (negative change from baseline) demonstrate impaired HRQoL.|From first patient first treatment until date of last efficacy data collection (study period up to 62 weeks). HRQoL assessed at baseline (BL), end of treatment Cycles 2 and 4, and at end of treatment|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. Of the 52 treated subjects, 50 subjects completed the FACT-L at baseline (screening) and post-treatment.||scores on a scale||Standard Deviation|Mean
173079|NCT00101413|Secondary|Percentage of Subjects With Stable Disease (SD)|Percentage of subjects with stable disease was calculated from date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Descriptive summary of subjects with SD.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.||Percentage of participants|||Number
173080|NCT00101413|Secondary|Overall Survival|"Overall survival was calculated from the date of the first treatment until death of the subject.~Evaluation by Kaplan-Meier methodology, descriptive analysis."|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.||days||95% Confidence Interval|Median
173081|NCT00101413|Secondary|Duration of Stable Disease|Duration of stable disease was calculated as date of first treatment until date of documented progressive disease (PD) or last observation if subject did not progress. Stable disease (SD) defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Kaplan-Meier methodology, descriptive analysis.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 1 of the 52 subjects had lung metastases from pancreatic cancer and was excluded from analysis. 48 subjects had tumor evaluations post-baseline and were evaluable.||days||95% Confidence Interval|Median
173082|NCT00101413|Primary|Anti-cancer Activity (eg, Percentage of Patients With Confirmed Complete Responses (CR) and Partial Responses (PR) Per RECIST (Response Evaluation Criteria in Solid Tumors) Criteria in Patients With Stage IV Non-small Cell Lung Carcinoma (NSCLC)|CR-disappearance of clinical/radiological tumor evidence (target/nontarget). PR- >=30% decrease in sum longest diameter (LD) of target lesions from BL sum LD. Stable disease (SD)-no shrinkage for PR nor increase for PD. Progressive disease (PD) measurement proven- >=20% increase in sum LD of lesions from smallest sum LD since start or new lesions. Progression by clinical judgement- >clinically meaningful cancer-related deterioration as judged by the investigator.|First patient first treatment until date for last data collection for efficacy for a study period up to 62 weeks. Tumor assessed per RECIST at baseline (BL), every 8 weeks during treatment and at end of treatment.|The analysis population for the intent to treat (ITT) and safety analyses consisted of 52 subjects who received at least 1 treatment and had their disease re-evaluated. 51 subjects were considered evaluable since 1 of the 52 subjects had lung metastases from pancreatic cancer.||percentage of participants|||Number
173086|NCT00101400|Secondary|Time to Objective Response|Defined only for subjects achieving objective tumor response from start of treatment to the date when confirmed PR or CR was first documented according to the Modified WHO Tumor Response Criteria.|Until objective response occurs|1 subject out of 54 achieved PR.||days|||Number
173087|NCT00101400|Secondary|Time to Progression|Time from start of treatment until progression was first documented.|Until progression occurs|Of the intent to treat population, 4 subjects died before assessment of progression; for 1 subject the progression date not available; and 1 subject was lost to follow-up.||days||95% Confidence Interval|Median
173088|NCT00101400|Primary|Number of Subjects With Response (Complete or Partial)|Number of subjects with metastatic breast cancer treated with single agent BAY43-9006 who had best overall response assessed as complete response (CR) or partial response (PR) as per Modified World Health Organization (WHO) Tumor Response Criteria.|Until 30 days after termination of active therapy|Intent to treat population consisted of subjects who received at least 1 dose of sorafenib.||participants|||Number
173089|NCT00101361|Primary|A Healed Pressure Ulcer|Patients remained in treatment until full healing of the target pressure ulcer (defined as re-epithelialization to a cicatrix with a dry surface and zero open area for a minimum of 96 hours) or 24 weeks, whichever occured first.|healing was measured from randomization to full healing or 24 weeks, whichever occured first.|||participants|||Number
173090|NCT00101283|Secondary|Progression-Free Survival|Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.||Months||95% Confidence Interval|Median
173091|NCT00101283|Secondary|Overall Survival|Time from randomization to death. Patients alive at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.||Months||95% Confidence Interval|Median
173092|NCT00101283|Primary|Best Overall Response by RECIST Criteria (Version 1.0)|Number of eligible, treated participants in each response category by RECIST criteria. Response categories represent best response for each patient prior to progression.|Assessed every 2 cycles (6 weeks) while on treatment, then every 3 months for 2 years, then every 6 months for 1 year until disease progression|The population consisted of all eligible, treated patients. 3 patients randomized to pemetrexed/gemcitabine who withdrew prior to treatment are excluded.||eligible, treated participants|||Number
173093|NCT00101192|Secondary|Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment||up to 5 years from study entry||||||
173094|NCT00101192|Primary|Tumor Response|"Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria:~Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart.~Partial Response(PR): at least a 30% decrease in the sum of longest dimensions(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions.~Increasing Disease: at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Stable Disease: any condition not meeting the above criteria.~Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|up to 6 months from study entry|Eligible and evaluable participants||participants|||Number
173095|NCT00101166|Secondary|Overall Survival (OS) in Months|Average overall survival time in months.|Average of 14 months|All 28 participants who were vaccinated on this study.||months||95% Confidence Interval|Mean
173096|NCT00101166|Secondary|Time to Progression (TTP) in Months|Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Average of 14 months|All 28 participants who were vaccinated on this study.||months||95% Confidence Interval|Mean
173097|NCT00101166|Secondary|Number of Participants With Stable Disease|Patients with stable disease by RECIST criteria after 3 vaccine injections. Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Average of 14 months|All 28 participants who were vaccinated on this study.||participants|||Number
173098|NCT00101166|Primary|Number of Participants With Partial Response|Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Average of 14 months|All 28 participants who were vaccinated on this study.||participants|||Number
173099|NCT00101166|Secondary|Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment|Frequency of Study Related Toxicity. To evaluate the toxicity of the autologous tumor cell / GM.CD40L bystander cell vaccine. Toxicity was scored using the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE-3).|Average of 14 months|All 28 participants who were vaccinated on this study.||participants|||Number
173100|NCT00101101|Secondary|Median Event Free Survival (EFS)|Vaccine Response - EFS among participants who received vaccination. Event free survival (EFS) was calculated from date of enrollment until progression or death from any cause. Progressive disease (PD): At least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|18 months|Participants who received at least one vaccine injection.||months||95% Confidence Interval|Median
173118|NCT00100802|Primary|Occurrence of Death Attributable to Complications of Protocol Therapy|Number of deaths due to complications of protocol therapy.|While receiving protocol therapy (up to 301 days excluding delays) or within 30 days of Termination of Protocol Therapy|106 eligible patients out of 118 patients enrolled is the population basis for this outcome measure.||participants|Patients||Number
173101|NCT00101101|Secondary|Occurrence of Related Serious Adverse Events (SAEs)|Patients were monitored for toxicity every 4 weeks in clinic throughout the 4-month vaccination phase. This included clinical and laboratory evaluation (CBC, blood urea nitrogen (BUN), creatinine, electrolytes, liver function test (LFT), and serum LDH). Toxicity was defined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE-3) Version 3.0 (www.ctep.cancer.gov). Grade 3 or higher SAEs attributed to vaccination: Toxicity was assessed in the 23 patients who received at least one vaccine injection.|4 months per participant|Participants who received at least one vaccine injection.||participants|||Number
173102|NCT00101101|Primary|Rate of Immunological Response to Vaccination|"Immunological response to vaccination, as measured by in vitro testing of peripheral blood mononuclear cells (PBMCs) for interferon gamma secretion, delayed type hypersensitivity reaction (DTH) in response to irradiated autologous tumor cells, and lymphocyte accumulation at DTH and vaccine injection sites.~DTH Skin Testing was performed within 2 weeks prior to first vaccine, and again after fourth vaccine was administered. Aliquots containing 10^6 irradiated autologous tumor cells were re-suspended in 0.2 mL of Plasma-Lyte A and injected intradermally in the forearm and marked. 48 hours later, injection site was inspected for induration and erythema.~3mm punch biopsy of DTH injection site and vaccine site was obtained 48 hours after administration of irradiated tumor cells before and after the vaccine series. Vaccine site biopsy was obtained 2-5 days after the second vaccine had been given. Granulocytic and lymphocytic accumulation at these sites was graded by a pathologist."|4 months per participant|Participants who received at least one vaccine injection.||participants|||Number
173103|NCT00101036|Secondary|Disease Control Rate (i.e., the Mathematical Sum of Percentages of Complete Response, Partial Response and Stable Disease)||Up to 5 years||||||
173104|NCT00101036|Secondary|Progress-free Survival|Estimated using the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions.|Up to 5 years|||Months||95% Confidence Interval|Median
173105|NCT00101036|Secondary|Overall Survival|Estimated by the Kaplan-Meier method.|Up to 5 years|||Months||95% Confidence Interval|Median
173106|NCT00101036|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT, MRI or X-Ray: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 5 years|||percentage of responding patients|||Number
173107|NCT00100932|Secondary|Overall Survival|Defined as the time from the start of study medication until death from any cause.|From time of start of study medication until death||||||
173108|NCT00100932|Secondary|Progression Free Survival|Defined as the time from the start of study medication until progressive disease or death from any cause during the study period.|From start of study medication until progressive disease or death|Intent to Treat/Safety Population||Days||Full Range|Median
173109|NCT00100932|Secondary|Duration of Response|Measured from the time that measurement criteria were met for complete response (CR) and partial response (PR) until the first date that recurrence or progressive disease was objectively documented.|From time of CR or PR until recurrence or progressive disease|Intent to Treat/Safety Population||Days||Full Range|Median
173110|NCT00100932|Primary|Overall Objective Response Rate (ORR)|Based on Response Evaluation Criteria in Solid Tumors (RECIST), consisting of complete response (CR) plus partial response (PR). Defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|From start of treatment until disease progression or recurrence|Intent to Treat/Safety Population||percentage of participants|||Number
173111|NCT00100841|Primary|Progression Free Survival Rate||From randomization to the first documented disease progression|||months||95% Confidence Interval|Median
173112|NCT00100841|Primary|Severe Adverse Event (SAE) Rate|The primary objective is to evaluate safety in all treated patients specifically the rate of serious adverse events which were defined as grade 5 events, grade 4 hemorrhage or thrombosis or bowel perforation|The duration of the study|66 patients treated with cetuximab||participants|||Number
173113|NCT00100815|Secondary|Overall Survival||every 2-4 months for 1 year and then every 6 months for 5 years|All treated and eligible patients||months||90% Confidence Interval|Median
173114|NCT00100815|Secondary|Clinical Response|Response was evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Overall Response (OR) = CR + PR.|Pre-treatment and every 6 weeks from treatment.|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
173115|NCT00100815|Secondary|Percentage of Participants With Improved Quality of Life|Quality of Life was assessed using EORTC QLQ-PAN26. All measures range in score from 1 to 4 as lower scores indicate better outcomes. The improved Quality of Life is defined as a greater than 5% decrease in 2 consecutive scores compared with the baseline score.|assessed at baseline then weekly for 3 weeks|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
173116|NCT00100815|Secondary|Percentage of Participants With Grades 3-5 Treatment Related Toxicities|Grade 3, 4 or 5 toxicity rate|Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years|All treated and eligible patients||percentage of participants||95% Confidence Interval|Number
173117|NCT00100815|Primary|Progression-free Survival|Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.|every 2-4 months for 1 year and then every 6 months for 5 years|All treated and eligible patients||months||95% Confidence Interval|Median
173120|NCT00100789|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events after the first cycle of treatment and then every three months while on treatment.|Eligible patients who received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants with a given type of AE|||Number
173121|NCT00100789|Secondary|Response|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Normalization of markers and other normal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration.|9 weeks - 3 years|All eligible patients with measurable disease who started treatment were included in response measures.||participants|||Number
173122|NCT00100789|Primary|Overall Survival|Measured from time of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.|0 - 3 years|All eligible patients who started treatment were included in this measure.||months||95% Confidence Interval|Median
173123|NCT00100789|Secondary|Progression-free Survival|Measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.|0 - 3 years|All eligible patients who started treatment were included in this measure.||months||95% Confidence Interval|Median
173124|NCT00100698|Secondary|Change in Systolic Blood Pressure|Change in systolic blood pressure|18 months|||mm Hg||Standard Error|Mean
173125|NCT00100698|Secondary|Change in 2-hour Glucose|Change in 2-hour glucose|18 months|||mg/dL||Standard Error|Mean
173126|NCT00100698|Secondary|Change in Extremity Fat|Change in extremity fat|18 months|||kilograms||Standard Error|Mean
173127|NCT00100698|Secondary|Change in Body Mass Index|Change in body mass index|18 months|||kilogram/meters squared||Standard Error|Mean
173128|NCT00100698|Secondary|Change in Carotid Intima Media Thickness (IMT)|change in carotid intima media thickness (IMT)|18 months|||millimeter||Standard Error|Mean
173129|NCT00100698|Secondary|Change in Adiponectin|Change in adiponectin|18 months|||mcg/mL||Standard Error|Mean
173130|NCT00100698|Secondary|Change in Diastolic Blood Pressure|Change in diastolic blood pressure|18 months|||mm Hg||Standard Error|Mean
173131|NCT00100698|Secondary|Change in Quality of Life Score From the Medical Outcomes Study-HIV Survey From Baseline to 18 Months|Change in quality of life score was measured by the Medical Outcomes Study-HIV (MOS-HIV)survey. The MOS-HIV asks patients to report on health-related quality of life and physical function from the past 4 days. The scoring range is 0-100, and a higher score indicates better quality of life.|18 months|||units on a scale||Standard Error|Mean
173132|NCT00100698|Secondary|Change in Lean Body Mass|change in lean body mass|18 months|||kilograms||Standard Error|Mean
173133|NCT00100698|Secondary|Change in Logarithm HIV Viral Load|Change in logarithm base 10 HIV viral load|18 months|||log base 10 copies of RNA/milliliter||Standard Error|Mean
173134|NCT00100698|Secondary|Change in CD4 Cells|Change in CD4 cells|18 months|||cells/microliter||Standard Error|Mean
173135|NCT00100698|Secondary|Change in Subcutaneous Adipose Tissue|Change in subcutaneous adipose tissue|18 months|||centimeters squared||Standard Error|Mean
173136|NCT00100698|Secondary|Change in Triglycerides|Change in triglycerides|18 months|||mg/dL||Inter-Quartile Range|Median
173137|NCT00100698|Secondary|Change in Trunk to Extremity Ratio|change in trunk to extremity ratio|18 months|||kilogram per kilogram||Standard Error|Mean
173138|NCT00100698|Secondary|Change in Fasting Glucose|change in fasting glucose|18 months|||mg/dL||Standard Error|Mean
173139|NCT00100698|Secondary|Change in Trunk Fat||18 months|||kilograms||Standard Error|Mean
173140|NCT00100698|Secondary|Change in Insulin-like Growth Factor-I From Baseline to 18 Months|Change in insulin-like growth factor-1|18 months|||nanograms/milliliter||Standard Error|Mean
173141|NCT00100698|Primary|Change in Visceral Adipose Tissue Area From Baseline to 18 Months|change in visceral adipose tissue area as measured by single-slice abdominal computed tomographic scan|18 months|||centimeters squared||Standard Error|Mean
173142|NCT00100659|Secondary|Adverse Events|Influenza-like, headache, and gastrointestinal symptoms|Every study visit||||||
173143|NCT00100659|Secondary|Laboratory Assessments|complete blood count,blood urea nitrogen,creatinine, glucose,calcium, phosphorus, aspartate aminotransferase,alanine aminotransferase, alkaline phosphatase, bilirubin|Every study visit||||||
173144|NCT00100659|Secondary|Vital Signs Events.|Heart rate, blood pressure, respirations|Every study visit||||||
173145|NCT00100659|Primary|Sustained Viral Response (SVR)|SVR is defined as nondetectable hepatitis C virus ribonucleic acid (HCV RNA) in plasma|at least 24 weeks after stopping treatment.|||participants|||Number
173146|NCT00099632|Secondary|Number of Participants Who Discontinued Study Treatment Prematurely|participants assigned to 7-day treatment arm and 21-day treatment arm were supposed to stay in study treatment for 7 days and 21 days respectively.|From first day of study treatment to last day of study treatment (up to 21 days)|||participants|||Number
173147|NCT00099632|Secondary|Severe (Grade 3) and Higher Adverse Events and Any Grade Adverse Event That Leads to a Treatment Change From First Day of Study Treatment to Week 12|"Grade 3 or higher signs and symptoms, laboratory abnormalities, events that are reported through the EAE system, and any grade event that leads to a treatment change from first day of study treatment to week 12.~Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death"|From first day of study treatment to week 12|||participants|||Number
173148|NCT00099632|Secondary|Number of Participants With New PI-resistant Variants as Detected by Standard Composite (Bulk) Genotyping.|For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.|2 and 6 weeks after completion of treatment|||participants|||Number
173149|NCT00099632|Secondary|Number of Participants With New Circulating NRTI-resistant Variants Detected by Standard Composite (Bulk) Genotyping.|For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed.|2 and 6 weeks after completion of treatment|||participants|||Number
173150|NCT00099632|Primary|Number of Participants With New Circulating Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI)-Resistant Variants as Detected by Standard Composite (Bulk) Genotyping|"For the 7-day treatment duration group, only the genotype results from weeks 3 and 7 contributed to the primary endpoint; For the 21-day treatment duration groups, only the genotype results from weeks 5 and 9 contributed to primary endpoint.~10 participants who did not have resistance samples available were excluded from the primary endpoint analysis."|2 and 6 weeks after completion of treatment|412 women with primary endpoint results available||participants|||Number
173151|NCT00100230|Other Pre-specified|Loss of Peripheral Visual Fields|Hypothesis: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of peripheral visual fields in this 4-year trial.|4 years|Only participants completing at least one year of trial||decibels (dB)||Standard Error|Mean
173152|NCT00100230|Secondary|Rate of LOSS of Rod Electroretinographic Function|Hypothesis #1: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of rod electroretinographic response in this 4-year trial.|4 years|Number of participants completing at least one year of trial (i.e., modified intent to treat cohort)||change in amplitude, log microvolts/year||Standard Error|Mean
173153|NCT00100230|Primary|Rate of LOSS of 31 Hertz Cone Electroretinographic Function|Hypothesis #1: Elevation of red blood cell-docosahexaenoic acid levels will slow the progressive loss of 31 hertz cone electroretinographic response in this 4-year trial.|4 years|Number of participants completing at least one year of trial (i.e., modified intent to treat cohort)||log microvolts/year||Standard Error|Mean
173154|NCT00100178|Primary|Mean Stimulated C-peptide Area Under the Curve|The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes.|2 years|Participants who completed a 4-hour mixed meal glucose tolerance test at the two-year visit were included in the analysis||pmol/ml||95% Confidence Interval|Geometric Mean
173155|NCT00100048|Other Pre-specified|Number of Patients That Discontinued With LAEs||48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
173156|NCT00100048|Secondary|Change From Baseline in CD4 (T-helper) Cell Count at Week 240|Change in number of CD4 cells/mm^3 from baseline to Week 240.|Baseline and Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.||cells/mm^3||95% Confidence Interval|Mean
173157|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.|Baseline and Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.||Log10Copies/mL||95% Confidence Interval|Mean
173158|NCT00100048|Secondary|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ Standard Assay.|Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.||Participants|||Number
173159|NCT00100048|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline and Week 96|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.||cells/mm3||95% Confidence Interval|Mean
173160|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 96||Baseline and Week 96|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.||copies/mL||95% Confidence Interval|Mean
173161|NCT00100048|Secondary|Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96||96 Weeks|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis. All patients switched to MK0518 400 mg b.i.d post 48 weeks.||participants|||Number
173162|NCT00100048|Secondary|Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)|Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)|Baseline and Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||cells/mm3||95% Confidence Interval|Mean
173163|NCT00100048|Secondary|Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)|Mean change from baseline at Week 24 in plasma HIV RNA (copies/mL)|Baseline and Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||copies/mL||95% Confidence Interval|Mean
173164|NCT00100048|Primary|Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240|HIV RNA levels were determined by AMPLICOR HIV-1 Monitor™ UltraSensitive Assay.|Week 240|Modified-Intention-to-Treat (MITT): participants were included in the treatment group to which they were randomized, regardless of adherence to the entry criteria, treatment actually received, and deviation from the protocol. Participants who were randomized but never dosed were not included in the analyses.||Participants|||Number
173165|NCT00100048|Primary|Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)|"An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to its use. Any worsening of a preexisting condition which was temporally associated with the use of the study drug, was also an AE.~A SAE was any AE that resulted in death, was life threatening, resulted in a persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was cancer, or was an overdose."|Week 240|The analysis population was based upon the All Patients As Treated (APaT) approach.||Participants|||Number
173166|NCT00100048|Secondary|Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)||Week 24|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||participants|||Number
173167|NCT00100048|Primary|Number of Patients With Serious CAEs and Non-serious CAEs at Week 144|"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product~An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product"|144 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
173168|NCT00100048|Primary|Number of Patients With Serious CAEs (Cohort I and II Combined)|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
173169|NCT00100048|Other Pre-specified|Number of Patients With Serious Drug-related LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
173170|NCT00100048|Other Pre-specified|Number of Patients With Drug-related LAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
173171|NCT00100048|Other Pre-specified|Number of Patients With Serious LAEs|Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
173172|NCT00100048|Other Pre-specified|Number of Patients With Laboratory Adverse Experiences (LAEs)|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|48 Weeks|"The analysis population is based upon the All~Patients As Treated (APaT) approach."||participants|||Number
173173|NCT00100048|Other Pre-specified|Number of Patients That Discontinued With CAEs||48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
173174|NCT00100048|Other Pre-specified|Number of Patients With Serious Drug-related CAEs|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.|48 Weeks|The analysis population is based upon the All Patients As Treated (APaT) approach||participants|||Number
173175|NCT00100048|Other Pre-specified|Number of Patients With Drug-related CAEs|Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
173176|NCT00100048|Other Pre-specified|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48||48 weeks|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||participants|||Number
173177|NCT00100048|Primary|Number of Patients With Clinical Adverse Experiences (CAEs)|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|48 weeks|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
173178|NCT00100048|Primary|Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)||Week 24|"The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.~All patients who took study medication and had HIV RNA tests performed were included in the analysis."||participants|||Number
173179|NCT00100048|Primary|Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)|"An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.~Serious CAEs are any AEs occurring at any dose that; Results~in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or~prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an~overdose."|10 days|The analysis population is based upon the All Patients As Treated (APaT) approach.||participants|||Number
173180|NCT00100048|Primary|Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)|Mean change from baseline on Day 10 in plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) (copies/mL)|Baseline and Day 10|The analysis population is based upon the modified intent to treat (MITT) approach, where patients are included in the treatment group to which they were randomized. Patients who were randomized but never dosed are not included in the analysis.||copies/mL||95% Confidence Interval|Mean
173181|NCT00099983|Primary|Change in CAPS Score From Baseline to Week 24|The primary outcome measure for this study was the total score on the 34-item Clinician-Administered PTSD Scale (CAPS). This study was the intent-to-treat analysis of the improvement in PTSD symptoms from baseline to week-24 follow-up as measured by the CAPS. Total score range for the CAPS is 0-136 with higher values representing a worse outcome. This study was powered initially to detect a 9-point difference between the treatment groups in the CAPS change score.|24 Weeks|||units on a scale||95% Confidence Interval|Least Squares Mean
173182|NCT00099437|Secondary|Overall Survival (OS) - Follow-up|Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring during the study as a whole until the data cut-off for the survival extension (31st October 2011) are presented (analysis at 75% deaths)|Median time (in months) from randomisation until death (from any cause),up to 80 months|All randomised patients||months||Full Range|Median
173183|NCT00099437|Secondary|Change From Randomisation in Trial Outcome Index (TOI) Over the Course of the Study|Mean (and standard deviation) change from randomisation until treatment discontinuation in TOI (defined as the first visit response of 'worsened' which is a decrease in TOI from baseline of 5 points or more) using the Kaplan-Meier method. If a subject has not shown a reduction of 5 points or more at the time of analysis then the observation will be right censored using the last QOL assessment date. Trial Outcome Index (TOI) is derived from the FACT-B questionnaire (Cella et al, 1993) by adding together the scores from the following 3 subscales; Physical well-being (PWB), Functional well-being (FWB) and Breast cancer subscale (BCS). The TOI score range is 0-92 with the higher scores representing the more favourable outcomes. Data were collected from a subgroup of patients.|TOI questionnaires were completed every 4 weeks from randomisation until week 24 and then again at treatment discontinuation, for study duration (48 months)|||Scores on a scale||Standard Deviation|Mean
173184|NCT00099437|Secondary|Overall Survival (OS)|Median time (in months) from randomisation until death (from any cause) (analysis at 50% deaths )|Overall Survival is equivalent to time to death. For this endpoint, all deaths occurring for study duration (48 months)|All patients with measurable disease at baseline.||Time (in months)||Full Range|Median
173185|NCT00099437|Secondary|Duration of Clinical Benefit (DoCB)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) >=24 weeks|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|||Time (in months)||Full Range|Median
173186|NCT00099437|Secondary|Duration of Response (DoR)|Time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who achieve a confirmed complete response (CR) or confirmed partial response (PR)|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|||Time (in months)||Full Range|Median
173187|NCT00099437|Secondary|Clinical Benefit Rate (CBR)|A Clinical Benefit (CB) responder is defined as a patient having a best overall response of CR, PR or SD (stable disease) >=24 weeks. The Clinical Benefit Rate is the percentage of patients with CB.|Clinical Benefit from the sequence of RECIST scan data for study duration (48 months) . RECIST (Response Evaluation Criteria in Solid Tumours) scans were performed every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|||Percentage of patients|||Number
173188|NCT00099437|Secondary|Objective Response Rate (ORR)|Using the RECIST scan data, an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR) which is subsequently confirmed as per RECIST. ORR is defined as the percentage of patients with OR.|RECIST tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|All patients with measurable disease at baseline.||Percentage of patients|||Number
173189|NCT00099437|Primary|Time to Progression (TTP)|Median time (in months) from randomisation until objective disease progression or death (in the absence of objective progression).|RECIST(Response Evaluation Criteria in Solid Tumors ) tumour assessments carried out every 12 weeks (+/- 2 weeks) from randomisation for study duration (48 months)|||months||Full Range|Median
173190|NCT00099359|Secondary|NVP Pharmacokinetics|Descriptive study of NVP pharmacokinetics during first two weeks of life using weight band dosing in a subset of enrolled infants.|14 days|||ng/mL||Full Range|Median
173191|NCT00099359|Secondary|Risk Factors for Perinatal HIV-1 Transmission|Risk factors to be assessed include maternal HIV-1 RNA levels at delivery, maternal syphilis and other infections, obstetrical factors such as duration of membrane rupture, and adherence to neonatal medication.|through age 3 months|All available demographic and clinical variables were tested for association with transmission rate. All variables that were significant at p ≤ 0.20 were included in the multivariable regression model. Variables that were not significant were then removed from the model. The backward elimination method was used to select the final model.||participants|||Number
173192|NCT00099359|Secondary|3TC and NFV Pharmacokinetics|Descriptive study of 3TC and NFV pharmacokinetics during first two weeks of life using weight band dosing regimen in a subset of enrolled infants.|through age 14 days|This was a descriptive study. A total of 26 infants were analyzed with 14 at age 4-7 days and 12 at 10-14 days.Plasma samples were collected prior to first AM dose and then at 1,2,4,8 and 12 hours.||ug*h/mL||Full Range|Median
173193|NCT00099359|Secondary|Clinical Covariates of HIV-1 Infection|Compare HIV-1 RNA levels; CD4+ lymphocyte counts; and rates of genotypic and phenotypic resistance among the three treatment regimens.|through age 3 months||||||
173194|NCT00099359|Secondary|Participant Deaths||through age 6 months|||participants|||Number
173195|NCT00099359|Secondary|Infant HIV-1 Infection Status|In utero HIV-1 infection rate|birth|||participants|||Number
173196|NCT00099359|Primary|Participants With Serious Adverse Events|Serious Adverse Events by System Organ Class=Blood and lymphatic system disorders|through age 6 months.|||participants|||Number
173198|NCT00099268|Secondary|Change From Baseline in Health-related Quality of Life Assessed Using the 39-item Parkinson's Disease Questionnaire (PDQ-39)|The PDQ-39 instrument is used to assess quality of life in individuals with Parkinson’s disease. The questionnaire provides scores on eight scales: Mobility, activities of daily living, emotions, stigma, social support, cognition, communication, and bodily discomfort. Questions are scored on a 5-point Likert scale ranging from 1 (never) to 3 (sometimes) to 5 (always). The total score can range from 39 to 190. A lower score indicates better quality of life. A negative change score indicates an improvement.|Baseline to Week 156|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.||Units on a scale||Standard Deviation|Mean
173199|NCT00099268|Secondary|Occurrence of Dyskinesia|Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered “yes” to the following question: “In your opinion, does this patient have dyskinesia?”|Baseline to Week 208|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued from treatment before 134 weeks without dyskinesia were excluded.||Participants|||Number
173200|NCT00099268|Secondary|Time to First Occurrence of Wearing-off|Wearing off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient whether he/she had noticed that the benefits of the study drug wear-off. A motor complications and patient questionnaire card were provided to assist the blinded rater in determining whether a patient had experienced wearing-off.|Baseline to end of study (134-208 weeks of treatment)|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.||Weeks||Standard Error|Mean
173201|NCT00099268|Secondary|Occurrence of Wearing-off|Wearing-off is defined as a perception of loss of mobility or dexterity, usually taking place gradually over minutes (up to an hour) and usually bearing a close temporal relationship to the timing of anti-parkinsonian medications; it does not include early-morning akinesia. To ascertain its occurrence, a blinded rater questioned the patient as to whether he/she had noticed that the benefits of the study drug were wearing-off.|Baseline to Week 134|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization. Subjects who discontinued treatment before 134 weeks without wearing-off were excluded.||Participants|||Number
173202|NCT00099268|Secondary|Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score (Parts II and III)|The UPDRS is a standardized assessment scale used to measure the patient’s disease state. It was to be completed by a blinded rater. There are 6 parts to the UPDRS. Part II (items 5-17; total score 0-52 units on the scale) measures the patient’s activities of daily living and part III (items 18-31; total score 0-56 units on the scale) measures the motor function of the patient. The total score ranges from 0 to 108 units on the scale. A higher score indicates greater disability. A negative change score indicates improvement.|Baseline, Week 6 and Week 130|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.||Units on a scale||Standard Deviation|Mean
173203|NCT00099268|Primary|Time to First Occurrence of Dyskinesia|Dyskinesia was assessed by a blinded rater at each visit. Time to dyskinesia was defined as the visit at which the rater first answered “yes” to the following question: “In your opinion, does this patient have dyskinesia?” Time to dyskinesia was estimated by Kaplan-Meier product limit estimate that takes into consideration patients who did not experience dyskinesia by censoring them at the end of the study.|Treatment duration for an individual patient varied between a minimum of 134 weeks for those patients recruited last and a maximum of 208 weeks for those patients recruited first|The intent to treat (ITT) population consisted of all patients randomized who received at least one dose of study drug. Following the ITT principle, patients were analyzed according to the treatment they were assigned at randomization.||weeks||95% Confidence Interval|Number
173204|NCT00099047|Primary|Changes in M-protein Levels|For a given biomarker (or a suitable transformation of it, e.g. log transform) t-tests and Wilcoxon tests (2-sample t-test and Wilcoxon rank sum test for between treatment comparisons, and paired 1-sample t-test and Wilcoxon signed rank test for within treatment comparisons) will be used to detect statistically significant differences between (or within) treatments.|Baseline and 6 months|One patient on the celecoxib arm was considered inevaluable and not included in this participants analyzed.||g/dL||Standard Deviation|Median
173205|NCT00099021|Secondary|Interleukin 6, 8 and Vascular Endothelial Growth Factors Elaboration in the Oral Cavity and Serum|Quantitative studies of serum and saliva components for a pre and post treatment possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
173206|NCT00099021|Secondary|Quantitative Oil Red O, AP2 (FABP4) and FABP5 Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
173207|NCT00099021|Secondary|Involucrin and Transglutaminase Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
173208|NCT00099021|Secondary|Cyclin D1 and p21 Immune Histochemistry|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
173209|NCT00099021|Secondary|Cyclooxygenase-2 Staining|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
173210|NCT00099021|Secondary|Pigliotazone Gamma Immune Histochemistry|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
173211|NCT00099021|Secondary|Apotosis (Cell Death)|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
173212|NCT00099021|Secondary|Ki 67 Labeling Index|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
173213|NCT00099021|Secondary|Nf Kappa B p65|Immune histochemistry / tissue staining for a possible biomarker.|Pre (Day 0) and Post (Week 12) Treatment||||||
173214|NCT00099021|Secondary|Patients' Histological (Tissue) Response|Determined by biopsy results before and 4 weeks after treatment: Complete Response (CR) =complete reversal of dysplasia or hyperplasia, Partial Response (PR) = >or=50% decrease in sum of lesions, no increase in 1 or more lesions and no new lesion occurs, Stable Disease (SD0 = not CR, PR or Progressive Disease (PD), PD = >or= 25% increase in sum of lesions or new lesion or progression to invasive carcinoma.|Week 16 (4 weeks post dose)|||Participants|||Number
173215|NCT00099021|Secondary|Patients' Clinical Response|Determined by measurement of lesions- Complete Response (CR)= disappearance of all lesions, Partial Response (PR)= >or= 50% decrease in sum of lesions, Stable Disease (SD) = does not meet CR,PR or Progressive Disease (PD), and PD= >or= 25% increase in sum of lesions|Week 16 (4 weeks post dose)|||Participants|||Number
173216|NCT00099021|Primary|Patients' Overall Response|"Overall Response= reviewing both the clinical and histological responses and assigning the worst category.~Complete Response (CR) = Clinical CR and Histologic CR, or Histologic CR Partial Response (PR) = Clinical CR or PR and Histologic PR or Stable Disease (SD) Stable Disease (SD) = Clinical SD and Histologic PR or SD Progressive Disease (PD) = Clinical PD and/or Histologic PD"|Week 16 (4 weeks post dose)|||Participants|||Number
173217|NCT00098956|Secondary|Adverse Events, Graded Using the CTCAE Version 3.0||Up to 5 years||||||
173218|NCT00098956|Secondary|Overall Survival||From the date of enrollment to death or last contact, assessed up to 5 years||||||
173219|NCT00098956|Secondary|Progression-free Survival||From the date of enrollment to progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years||||||
173220|NCT00098956|Secondary|Duration of Responses||From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years||||||
173221|NCT00098956|Secondary|Stable Disease Rate Evaluated Using RECIST Criteria||Up to 5 years|||participants|||Number
173222|NCT00098956|Primary|Objective Response Rates (Complete and Partial) Evaluated Using RECIST Criteria||Up to 5 years|||participants|||Number
173223|NCT00098865|Secondary|Overall Survival|Time from registration to death. Patients alive at last follow-up were censored.|Assessed after treatment discontinued every 3 months up to 2 years.|The analysis dataset is comprised of all treated patients.||months||95% Confidence Interval|Median
173224|NCT00098865|Secondary|Overall Response|"Overall response is the best response during 6 months of therapy measured by radiographic response.~Complete Response (CR): Disappearance of all detectable tumors by imaging, if initially positive, as well as 2 consecutively negative CSF cytologic examinations (if the initial cytology was positive).~Partial Response (PR): > 50% reduction in the sum of the products of the maximum perpendicular diameter of all measurable lesions; or 2 consecutively negative CSF cytologies and a < 50% reduction in tumor size.~Stable Disease (SD): < 50% reduction in the sum of the products of the maximum perpendicular diameters of all measurable lesions, and persistently negative or positive CSF cytology Progressive Disease (PD): > 25% increase in the size of any measurable lesion, the appearance of a new radiographically demonstrable lesion, or the conversion of negative CSF cytology to positive, as confirmed by at least one repeat CSF cytology"|Assessed every 8 weeks while on treatment and every 3 months for one year off-study|||participants|||Number
173225|NCT00098865|Primary|Therapy Completion Rate|Feasibility in this study was defined as completion of 6 months of thalidomide with temozolomide therapy. The corresponding therapy completion rate is defined as the proportion of patients who completed 6 months of therapy.|6 months|The analysis dataset is comprised of all treated patients.||proportion of participants||90% Confidence Interval|Number
173226|NCT00098839|Secondary|Pharmacokinetics|Determined along with the mean, median, standard deviation and range of the parameters of interest. Statistical analysis will be purely descriptive.|Up to day 36||||||
173227|NCT00098839|Primary|Rate of Minimal Residual Disease (MRD) < 0.01%|Proportion of patients (evaluable and had MRD measured at the end of Block 1) who had MRD < 0.01%.|At the end of Block 1 of re-induction therapy (day 36)|Evaluable patients who had MRD measured at the end of Block 1. There were 2 ineligible patients for once weekly arm and 13 patients where MRD was not measured at the end of block 1 re-induction therapy. There were 16 patients for twice weekly arm where MRD was not measured at the end of block 1 re-induction therapy.||Proportion of participants|||Number
173228|NCT00098839|Primary|Event-free Survival Rate|Proportion of patients who were event free at 4 months|At 4 months after enrollment|Evaluable patients at the end of Block 1. There were 2 ineligible patients for once weekly arm and 6 patients not evaluable at the end of block 1 re-induction therapy. There were 10 patients for twice weekly arm not evaluable at the end of block 1 re-induction therapy.||Proportion of participants|||Number
173229|NCT00098839|Primary|Remission Re-induction (CR2) Rate|The proportion of patients who achieved complete response at the end Block 1 of re-induction therapy. Complete Remission (CR) - Attainment of M1 bone marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC >1000/uL and platelet count >100,000/uL). Partial Remission (PR) - Complete disappearance of circulating blasts and achievement of M2 marrow status (5% or < 25% blast cells and adequate cellularity). Partial Remission Cytolytic (PRCL) - Complete disappearance of circulating blasts and achievement of at least 50% reduction from baseline in bone marrow blast count. Minimal Response Cytolytic (MRCL) - 50% reduction in the peripheral blast count with no increase in peripheral white blood cell count.|At the end of Block 1 of re-induction therapy (day 36)|Evaluable patients at the end of Block 1. There were 2 ineligible patients for once weekly arm and 6 patients not evaluable at the end of block 1 re-induction therapy. There were 10 patients for twice weekly arm not evaluable at the end of block 1 re-induction therapy.||proportion of participants|||Number
173230|NCT00098813|Primary|Tumor Major Response Rate (Including Stable Disease) as Measured by RECIST Criteria||From start of treatment to 8 weeks|||participants|||Number
173231|NCT00098787|Secondary|Overall Survival (OS)|Overall survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to death. Patients alive at last follow-up were censored.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.|Eligible and treated patients||months||95% Confidence Interval|Median
173553|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 12|Laboratory hematology total neutrophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
173232|NCT00098787|Secondary|Progression-Free Survival (PFS)|Progression-free survival is defined as time from randomization (to Arm A or Arm B) or registration (to Arm C) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months once the patient is 2-4 years post-registration.|Eligible and treated patients||months||95% Confidence Interval|Median
173233|NCT00098787|Primary|Objective Response Rate|Objective response rate is defined as proportion of patients who achieve complete response (CR) or partial response (PR). Response was assessed using Solid Tumor Response Criteria (RECIST). CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.|Assessed every 3 months if the patient is within 2 years of registration and every 6 months up to 4 years post-registration.|Eligible and treated patients||proportion||90% Confidence Interval|Number
173234|NCT00098774|Secondary|4 Year Overall Survival Rate|Percentage of patients who were alive at 4 years. The 4-year survival rate was estimated using the Kaplan Meier method.|4 years|||percentage of participants||95% Confidence Interval|Number
173235|NCT00098774|Secondary|Change From Baseline in Mini-Mental Status Evaluation at 4 Months|Neurologic functioning will be assessed using the Mini-Mental Status Evaluation (MMSE), a standardized, bedside tool for evaluation of higher mental function. This assessment is based on a 30-point scale (0-30) with higher scores associated with better performance.|Baseline & month 4|Only 14 participants had both baseline and 4 month MMSE evaluations reported.||units on a scale||Full Range|Median
173236|NCT00098774|Secondary|4 Year Progression Free Rate|"Percentage of patients who were progression free at 4 years. The 4-year progression free rate was estimated using the Kaplan Meier method.~Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a 25% increase of previous area of gadolinium enhancement, appearance of new areas of T1 gadolinium enhancement or new appearance of malignant cells in the spinal fluid or new tumor appearance in other sites of the body"|4 years|||percentage of participants||95% Confidence Interval|Number
173237|NCT00098774|Primary|Complete Response Rate After Remission Induction|Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.|4 months|||percentage of participants||95% Confidence Interval|Number
173238|NCT00098748|Secondary|Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 48)|Number of subjects with AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C Adverse Events per CDC HIV Classification System. Includes events occurring up to 7 days after last dose of study drug.|Baseline through Week 48|FAS - as randomized; N=number of subjects with Category C Adverse Events for maraviroc QD, maraviroc BID, and placebo, respectively. Week 48 results reflect subsequent updates to data originally reported at Week 24.||participants|||Number
173239|NCT00098748|Secondary|Number of Subjects With Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Illnesses (Analysis at Week 24)|Number of subjects with AIDS-defining opportunistic illnesses based on investigator classification guided by a predefined list of clinical Category C Adverse Events per Center for Disease Control (CDC) HIV Classification System. Includes events occurring up to 7 days after last dose of study drug.|Baseline through Week 24|FAS - as randomized; N=number of subjects with Category C Adverse Events for maraviroc QD, maraviroc BID, and placebo, respectively. Week 48 results reflect subsequent updates to data originally reported at Week 24.||participants|||Number
173240|NCT00098748|Secondary|Number of Subjects With Treatment Failure at Week 48 by Overall Susceptibility Score (OSS) at Screening|Number of subjects for association between screening resistance and virologic response as determined by treatment failure and OSS at screening. OSS categorized as 0, 1, 2, or ≥3 (maximum value of 6) and calculated as the sum of the net assessment of in vitro phenotypic and genotypic susceptibility using a binary scoring system (0= reduced susceptibility, 1=susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Screening, Week48|FAS - as treated dual-tropic subjects. Missing values imputed as LOCF.||particpants|||Number
173241|NCT00098748|Secondary|Number of Subjects With Treatment Failure at Week 24 by Overall Susceptibility Score (OSS) at Screening|Number of subjects for association between screening resistance and virologic response as determined by treatment failure and OSS at screening. OSS categorized as 0-1, 2-4, >4 (maximum value of 6) and calculated as the sum of the net assessment of in vitro phenotypic and genotypic susceptibility using a binary scoring system (0= reduced susceptibility, 1=susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Screening, Week 24|FAS - as treated dual-tropic subjects. Missing values imputed as LOCF.||participants|||Number
173242|NCT00098748|Secondary|Number of Subjects Per Tropism Status at Screening and Time of Treatment Failure (Analysis at Week 48)|Number of subjects per Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at Screening (Scr) and at time of treatment failure (Tx fail). Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). Tropism may have been assessed at either the Screening or Baseline visit. The assessment for time of treatment failure is defined as the last on-treatment assessment.|Screening through Week 48|FAS-as treated; N=subjects with TX failure due to insufficient clinical response and who had a tropism assessment at Screening. Subjects with DC prior to timepoint not included; LOCF if no result (viral load too low for analysis).||participants|||Number
173243|NCT00098748|Secondary|Number of Subjects Per Tropism Status at Screening and at the Time of Treatment Failure (Analysis at Week 24)|Number of subjects per Tropism status (CCR5 [R5], CXCR4 [X4], Dual Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at Screening (Scr) and at time of treatment failure (Tx fail). Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). Tropism may have been assessed at either the Screening or Baseline visit. The assessment for time of treatment failure is defined as the last on-treatment assessment.|Screening through Week 24|FAS-as treated; N=subjects with TX failure due to insufficient clinical response and who had a tropism assessment at Screening. Subjects with DC prior to timepoint not included; LOCF if no result (viral load too low for analysis).||participants|||Number
173244|NCT00098748|Secondary|Number of Subjects Per Genotype and Phenotype at Baseline and at Time of Failure|Number of subjects per genotype and phenotype (tests for presence of non CCR5-tropic HIV-1 and for resistance to reverse transcriptase, protease, and fusion inhibitors) at baseline and at time of failure through Week 48 visit. Sensitivity to drug categorized as 0-1, 2-4, >4; scores defined as 0=resistance, 1=sensitive or susceptible with higher number indicating greater sensitivity or susceptibility.|Baseline through Week 48|FAS-as treated dual-tropic subjects. Genotype and phenotype at screening and at time of failure were not summarized as planned.||participants|||Number
173245|NCT00098748|Secondary|Change From Baseline in Time Averaged Difference (TAD) in log10 HIV-1 RNA|Change from baseline of TAD in log10 HIV-1 RNA viral load calculated as [AUC of HIV-1 RNA viral load (log10 copies/mL) / time period] - Baseline HIV-1 RNA viral load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Discontinuations prior to time point of analysis imputed as 0.||log10 copies/mL||Standard Error|Mean
173246|NCT00098748|Secondary|Time (50% Quartile Point Estimate) to Virologic Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of test drug [perm DC]; lost to follow-up [LTFU]; new anti-retroviral drug added (except background drug change to drug of same class); or on open label for early non-response or rebound). Failure: at Time 0 if level not <400 copies/mL (2 consecutive visits) before event(s) or last available visit; at time of earliest event if level <400 copies/mL (on 2 consecutive visits); failure if level ≥400 copies/mL (2 consecutive visits) or 1 visit ≥400 copies/mL followed by perm DC or LTFU.|Day 1 through Week 24 and through Week 48|FAS - as treated dual-tropic subjects; (n)=number of subjects with virologic failure at observation for maraviroc QD, maraviroc BID, and placebo, respectively; Week 48 result values (0.00)=virologic failure at Day 0.||days||95% Confidence Interval|Median
173247|NCT00098748|Secondary|Change From Baseline in CD8 Cell Count|Change from baseline in CD8 cell count (measured as cells/µL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Placebo N: 4 subjects did not have on-treatment information. Missing data imputed using LOCF.||cells/µL||Standard Error|Mean
173248|NCT00098748|Secondary|Change From Baseline in CD4 Cell Count|Change from baseline in CD4 cell count (measured as cells per microliter [cells/µL]). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|FAS - as treated dual-tropic subjects. Placebo N: 4 subjects did not have on-treatment information. Missing data imputed using LOCF.||cells/µL||Standard Error|Mean
173249|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 50 Copies/mL||Baseline, Week 24, Week 48|FAS - as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).||participants|||Number
173250|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 1.0 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels|Number of subjects with HIV-1 RNA levels < 400 copies/mL or at least 1.0 log 10-transformed decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline, Week 24, Week 48|FAS-as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).||participants|||Number
173251|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL or at Least 0.5 Log 10-transformed Decrease From Baseline in HIV-1 RNA Levels|Number of subjects with HIV-1 RNA levels < 400 copies/mL or at least 0.5 log 10-transformed decrease from baseline in HIV-1 RNA levels. Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline, Week 24, Week 48|FAS-as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).||participants|||Number
173252|NCT00098748|Secondary|Number of Subjects With HIV-1 RNA Levels < 400 Copies/mL||Week 24, Week 48|FAS - as treated dual-tropic subjects. Missing values counted as failures/non-responders (counted as not achieving the stated criterion).||participants|||Number
173253|NCT00098748|Primary|Change From Baseline in Human Immunodeficiency Virus (HIV-1) Viral Load (Ribonucleic Acid [RNA])|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log 10 copies per milliliter [log10 copies/mL]). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and baseline visits.|Baseline to Week 24 and Week 48|Full Analysis Set (FAS)-as treated: all randomized subjects classified as dual-tropic by phenotype assay; received at least 1 dose of study treatment. Missing values: discontinuations (DC) imputed as baseline value (change from baseline=0); missing data imputed as Last Observation Carried Forward (LOCF).||log10 copies/mL||Standard Error|Mean
173254|NCT00098722|Secondary|Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.|Baseline, Week 24 and Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm measured at particular time-point. LOCF was used to impute missing values.||log10copies/mL||Standard Deviation|Mean
173255|NCT00098722|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status R5, X4, DM, or NR/NP at baseline and time of failure analyzed through week 48 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
173256|NCT00098722|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through Week 24|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
173257|NCT00098722|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.||participants|||Number
173258|NCT00098722|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through Week 24|FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.||participants|||Number
173259|NCT00098722|Secondary|Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening|Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs) and non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening|FAS included all the randomized participants who had taken at least one dose of the study medication.||participants|||Number
173260|NCT00098722|Secondary|Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline to Week 24 and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
173261|NCT00098722|Secondary|Time to Virological Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up[LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL (2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL (2 consecutive visits);failure if level >=400 copies/mL (2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication.||days||95% Confidence Interval|Median
173262|NCT00098722|Secondary|Change From Baseline in CD8 Cell Count at Week 24 and 48|Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells/μL||Standard Error|Least Squares Mean
173263|NCT00098722|Secondary|Change From Baseline in CD4 Cell Count at Week 24 and 48|Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells/μL||Standard Error|Least Squares Mean
173264|NCT00098722|Secondary|Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||cells per microliter (cells/μL)||Standard Deviation|Mean
173265|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels."||percentage of participants|||Number
173554|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 6|Laboratory hematology total neutrophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
173266|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels."||percentage of participants|||Number
173267|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels."||percentage of participants|||Number
173268|NCT00098722|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels."||percentage of participants|||Number
173269|NCT00098722|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as LOCF for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
173270|NCT00098722|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 24|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
173271|NCT00098722|Primary|Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline|Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.||log10 copies/milliliter(log10 copies/mL)||Standard Deviation|Mean
173272|NCT00098670|Secondary|Number of Participants With Severe Non-Hematologic Adverse Events During Treatment With Alemtuzumab|"The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity. Severe Adverse events are defined as grade 3, 4 or 5, at least possibly related to treatment.~Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|6 weeks beginning at study week 36|58 participants were treatment with Alemtuzumab.||participants|||Number
173273|NCT00098670|Secondary|2 Year Survival|Percentage of participants who were alive at 2 years. The 2 year survival was estimated using the Kaplan Meier method.|2 years from registration|||percentage of participants|||Number
173274|NCT00098670|Secondary|2 Year Progression Free Survival|Percentage of patients who were alive and progression free at 2 years. The 2-year progression free survival was estimated using the Kaplan Meier method.|2 years from registration|||percentage of participants|||Number
173275|NCT00098670|Secondary|Number of Participants With a Complete or Partial Response After Induction Therapy With Fludarabine & Rituximab|"Response, as defined by the National Cancer Institute Working Group (NCIWG):~CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy~PR: 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver/spleen size, presence/absence of constitutional symptoms; plus ≥1 of the following: ≥1500/μL polymorphonuclear leukocytes, >100,000/μL platelets, >11.0 g/dL hemoglobin or 50% improvement for these parameters without transfusions"|Up to 9 months|||participants|||Number
173276|NCT00098670|Primary|Number of Participants With a Complete Response After Treatment With Fludarabine & Rituximab Followed by Alemtuzumab|"A complete response, as defined by the National Cancer Institute Working Group (NCIWG):~- CR: no lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; normal complete blood count; confirmed by bone marrow (BM) aspirate & biopsy"|Duration of treatment (up to 13.5 months)|58 participants were treated with Alemtuzumab.||participants|||Number
173277|NCT00098475|Secondary|Proportion of Patients With Objective Response (First Phase, Step 2)|"Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only."|Assessed every 4 weeks for 16 weeks during Step 2|Only eligible patients were included in this analysis.||Proportion of patients||95% Confidence Interval|Number
173303|NCT00098306|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through week 24|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
173278|NCT00098475|Primary|Proportion of Patients With Objective Response (First Phase, Step 1)|"Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only."|Assessed every 4 weeks for 16 weeks during Step 1|Only eligible patients were included in this analysis.||Proportion of patients||95% Confidence Interval|Number
173279|NCT00098371|Secondary|Comparison of Clinical Response and Tumor Lysis in Vivo With Drug-induced Apoptosis and Mitochondrial Perturbation in Vitro as Assessed by Flow Cytometry|CLL cells will be incubated with control or flavopiridol (1 or 2.8 microMolar) for 4-hours followed by a 20 hours in media with 10% heat-inactivated human serum. Assessment of apoptosis following exposure of human CLL cells will be performed using annexin/PI flow cytometry. Patient samples with greater than 50% live cells (annexin-/PI-) following exposure to 2.8 microMolar flavopiridol will be considered to have insensitive disease. Patients whose CLL cells have less than 50% live cells at 1 microMolar will be considered to have highly sensitive disease.|At baseline|A subset of patients who had sufficient material were analyzed according to response only.||percentage of priming cells||Standard Deviation|Mean
173280|NCT00098371|Secondary|Levels of Mcl-1 mRNA, Mcl-1 Protein, HIF-1alpha Protein, HIF-1alpha mRNA, NF-kappaB Activation, Total IkB, IkB Phosphorylation, GSK-beta Activity, and IL-6 Target Genes (i.e., STAT3)|Assessed by real time RT-PCR (mcl-1, HIF-1alpha), immunoblot analysis (mcl-1, HIF-1alpha, I-kappaB, I-kappaB phosphorylation, targets of IL-6), and electrophoretic mobility shift analysis (NF-kappaB activation)|At baseline, 4.5 hours (end of continuous infusion), 8 hours, and approximately 24 hours following initiation of therapy|Data was not collected and analyzed for this outcome|||||
173281|NCT00098371|Secondary|Correlation of Adverse Prognostic Factors With Response to Flavopiridol Treatment as Assessed by Interphase Cytogenetics, VH Mutational Status, ZAP-70 Protein Expression, CD38, and p53|overall response rates (CR+PR)|up to 8 months|Data were not collected and analyzed for VH mutational status, ZAP-70 protein expression, CD38, and p53||percentage of patients in each subgroup|||Number
173282|NCT00098371|Secondary|Comparison of CLL Cell Samples Taken at Registration/Diagnosis to CLL Cell Samples Taken at Time of Relapse|Samples will be examined for ex vivo sensitivity to flavopiridol, expression of select anti-apoptosis proteins, BCRP mRNA and protein expression, difference in gene expression by cDNA microarray and potentially by epigenetic arrays. Comparisons will be used to evaluate mechanisms of acquired flavopiridol resistance.|At baseline and at time of relapse or when patient goes off therapy due to disease progression|Data for this outcome as not collected and analyzed|||||
173283|NCT00098371|Secondary|Serial Levels of IL-6 as Assessed by Blood Plasma|IL-6 measures were adjusted for baseline values|4.5 hours, 8 hours, 12 hours, and 24 hours following the initiation of therapy during day 1 of course 1|IL-6 expression analysis was available for only day 1 and not day 8.||pg/ml||95% Confidence Interval|Mean
173284|NCT00098371|Secondary|PK as Assessed by Levels of Both Flavopiridol and Metabolites of Flavopiridol in Urine Samples|urine samples were collected in some patients during the first 24 hours after the start of the infusion on cycle 1, day 1 to isolate metabolites of flavopiridol to be used as internal standard for plasma metabolite quantification experiments.|Urine collected at 4 separate times in some patients during the first 24 hours after start of infusion on day 1 of course 1.|Data for this PK analysis was not collected and analyzed.|||||
173285|NCT00098371|Secondary|PK (Cmax) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol|Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol|During treatment day 1 and day 8 of course 1|The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter.||μM||Standard Deviation|Mean
173286|NCT00098371|Secondary|Pharmacokinetics (PK) (AUC) as Assessed by Plasma Levels of Both Flavopiridol and Metabolites of Flavopiridol|Pharmacokinetics were performed on day 1 and day 8 of cycle 1 by plasma levels of both flavopiridol and metabolites of flavopiridol using Area Under the Curve (AUC)|During treatment day 1 and day 8 of cycle 1|The values are overall averages for all patients on days 1 and 8 - therefore, there is only a single value for each parameter.||μM*hr||Standard Deviation|Mean
173287|NCT00098371|Primary|Toxicity|Toxicity determination based on NCI Common Toxicity Criteria version 3 and modified NCI Common toxicity guidelines for evaluating hematologic toxicity in leukemia.|Measurement prior to each infusion, at end of therapy, 2 months post-completion and post-treatment follow-up every 3 months for two years.|Grade 3 to 4 infections requiring IV antibiotics and were generally related to upper or lower respiratory infections or infections of indwelling central venous catheters.||percentage of patients|||Number
173288|NCT00098371|Primary|Overall Survival|Overall survival data will be reported on a 3-month basis for 5 years|Up to 5 years|||months||95% Confidence Interval|Median
173289|NCT00098371|Primary|Progression-free Survival for All Patients as Assessed Using Standard Kaplan-Meier Methods|PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT were censored at the time of transplantation.|Up to 5 years|||months||95% Confidence Interval|Median
173290|NCT00098371|Primary|Progression-free Survival (PFS) for Responding Patients as Assessed Using Standard Kaplan-Meier Methods|PFS was calculated from the date of study entry until time of disease progression or death, whichever came first, censoring patients alive and relapse free at last follow up. Patients who withdrew from study to undergo an allogeneic SCT (Stem cell transplantation) were censored at the time of transplantation.|Up to 5 years|||months||95% Confidence Interval|Median
173291|NCT00098371|Primary|Response Duration|Response evaluation criteria based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response. Descriptive statistics will be computed (median, range, mean, standard deviation, minimum, and maximum) on response duration.|Up to 8 months|Duration of response was not collected for patients.|||||
173292|NCT00098371|Primary|Overall Response Rate (CR + PR)|CR requires all of the following: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC as exhibited by polymorphonuclear leukocytes > 1500/µL, platelets > 100,000/µL, hemoglobin > 11.0 g/dl (untransfused); lymphocyte count < 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with < 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent. Patients with CR after induction but wih treatment-related persistent cytopenia is a PR. PR requires a > 50% decrease in peripheral lymphocyte count from pretreatment value, > 50% reduction in lymphadenopathy, and/or > 50% reduction in splenomegaly/hepatomegaly. These patients must have one of the following: polymorphonuclear leukocytes > 1,500/μL , platelets > 100,000/μL, hemoglobin > 11.0 g/dl (untransfused) or any with 50% improvement from pretreatment value.|Up to 8 months|Schedule was amended (cycle length) from 42 to 28 days, reduction in the number of doses per cycle from 4 to 3 and administration of prophylactic dexamethasone 20 mg IV on each treatment day.||percent of patients||95% Confidence Interval|Number
173293|NCT00098371|Primary|Complete Response (CR) Rate|CR requires all of the following for at least two months from completion of therapy: Absence of lymphadenopathy in excess of 1 cm on physical exam; No hepatomegaly or splenomegaly on physical exam; Absence of constitutional symptoms; Normal CBC (complete blood count) as exhibited by polymorphonuclear leukocytes > 1500/µL, platelets > 100,000/µL, hemoglobin > 11.0 g/dl (untransfused); lymphocyte count < 5,000/µL; Bone marrow aspirate and biopsy must be normocellular for age with < 30% of nucleated cells being lymphocytes. Lymphoid nodules must be absent.|Up to 8 months|Patients were assessed for clinical response after two, four and six cycles.||percent of patients|||Number
173294|NCT00098345|Secondary|World Health Organisation (WHO) Performance Status|Number of patients demonstrating a worsening (increase in score of one or more from baseline) in WHO PS from baseline to 24 weeks. WHO PS is scored zero (Fully active) to 4 (completely disabled)|Performance status was assessed using the WHO criteria at baseline and because SD lasting for at least 24 weeks was used in the definition of disease control (in addition to confirmed objective response), WHO PS at 24 weeks was evaluated.|||Participants|||Number
173295|NCT00098345|Secondary|Symptomatic Response|Number of participants with a reduction of frequency and improvement in consistency of stool to normal (no more than 2 solid stools daily without concomitant anti-diarrheal medication) following administration of Caprelsa (vandetanib) denoted a symptomatic CR. An improvement in stool consistency to mostly semisolid and decrease in stool frequency to 50% or greater denoted symptomatic PR.|Symptomatic diarrhea was assessed using stool frequency and consistency diaries. Baseline was established using the average of the 4 days immediately prior to first dose on Day 5. Diaries were completed every day for the first 6 months on study drug.|||Participants|||Number
173296|NCT00098345|Secondary|Biochemical Response Calcitonin (CTN)|A patient's best biochemical response was calculated from assessments performed at baseline and during treatment. Responders were those patients with a confirmed best biochemical response of Complete Response or Partial (i.e. complete normalization of CTN or at least a 50% decrease in CTN from baseline).|Blood samples for analysis of CTN taken on Day 1 (every 3 hours for 24 hours), then a single sample on Day 5, weekly through the first 2 assessment periods, monthly (prior to amendment 7) and every 12 weeks (following amendments) until discontinuation|||Participants|||Number
173297|NCT00098345|Secondary|Disease Control Rate|Disease control rate was defined as the number of patients who had a best response of Complete Response (CR), or Partial Response (PR) or stable disease (SD) ≥24 weeks as defined according to RECIST 1.0.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.|||Participants|||Number
173298|NCT00098345|Secondary|Duration of Objective Response|Median duration of objective response as defined according to RECIST 1.0 from onset of response until data of objective disease progression or death from any cause in days.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.|||days||95% Confidence Interval|Median
173299|NCT00098345|Secondary|Progression Free Survival|Median time to progression defined according to RECIST 1.0 (months) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.|Upper limit is a censored value||months||Full Range|Median
173300|NCT00098345|Primary|Objective Response Rate|The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.|Pre-dose and every 12 weeks up to RECIST progression as defined according to RECIST 1.0.|||Participants|||Number
173301|NCT00098306|Secondary|Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.|Baseline, Week 24 and Week 48|FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm at particular time-point. LOCF was used to impute missing values.||log10copies/mL||Standard Deviation|Mean
173302|NCT00098306|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load <500 copies/mL categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.|Baseline and time of failure through week 48|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
173333|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression||Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
173304|NCT00098306|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug ‘sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through week 48|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.||participants|||Number
173305|NCT00098306|Secondary|Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug ‘sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening and time of failure through week 24|FAS; ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively.||participants|||Number
173306|NCT00098306|Secondary|Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening|Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs), non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug ‘sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.|Screening|FAS included all the randomized participants who had taken at least one dose of the study medication.||participants|||Number
173307|NCT00098306|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization and immediately pre-dose.|Baseline and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 48 have been imputed as the baseline value for participants who discontinued and as LOCF for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
173308|NCT00098306|Secondary|Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline to Week 24 and Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
173309|NCT00098306|Secondary|Time to Virological Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48|FAS included all the randomized participants who had taken at least one dose of the study medication.||days||95% Confidence Interval|Median
173310|NCT00098306|Secondary|Change From Baseline in CD8 Cell Count at Week 24 and 48|Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells/µL||Standard Error|Least Squares Mean
173311|NCT00098306|Secondary|Change From Baseline in CD4 Cell Count at Week 24 and 48|Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 24 and 48|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells/µL||Standard Error|Least Squares Mean
173312|NCT00098306|Secondary|Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline|FAS included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure.||cells per microliter (cells/µL)||Standard Deviation|Mean
173313|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels."||percentage of participants|||Number
173314|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 1.0 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels."||percentage of participants|||Number
173315|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 0.5 log10 Decrease From Baseline||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels."||percentage of participants|||Number
173316|NCT00098306|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL||Week 24 and 48|"FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as failure which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels."||percentage of participants|||Number
173317|NCT00098306|Primary|Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline and Week 24|FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 24 have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.||log10 copies/mL||Standard Error|Least Squares Mean
173318|NCT00098306|Primary|Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline|Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline|Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.||log10 copies/milliliter(log10 copies/mL)||Standard Deviation|Mean
173319|NCT00098293|Post-Hoc|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants|Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA.|Week 96|FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
173320|NCT00098293|Post-Hoc|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants|Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA.|Week 48|FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
173321|NCT00098293|Other Pre-specified|Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96||Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
173322|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening|Association between baseline resistance and virological response was assessed as percentage of participants with HIV-1RNA levels less than 50 copies/mL by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.|Baseline, Week 48, Week 96|Data not analyzed because of insufficient diversity amongst participants with respect to baseline resistance due to the study entry criteria regarding baseline resistance.|||||
173323|NCT00098293|Secondary|Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96|Genotypic resistance: mutations at screening by MBPSGT assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Efavirenz mutation:lysine to aspargine at r103(K103N);tyrosine to cysteine/isoleucine at r181(Y181C/I);tyrosine to cysteine/leucine/histidine at r188(Y188C/L/H);glycine to alanine/serine at r190(G190A/S);valine to alanine to r106(V106A);leucine to isoleucine at r100(L100I);alanine to glycine at r98(A98G);lysine to glutamic acid at r101(K101E);valine to isoleucine at r108(V108I);proline to histidine at r225(P225H);methionine to leucine at r230(M230L).|Screening, time of failure through Week 48, Week 96|FAS population; n=participants with treatment failure at specified time points for each arm group respectively. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination focus shifted from efficacy, safety to only safety as reflected in abbreviated set of efficacy noted in amended planned analysis.||participants|||Number
173324|NCT00098293|Secondary|Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96|Genotypic resistance to NRTIs was assessed by identification of relevant mutations at screening using MBPSGT assay and repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure through week 48 and week 96. Following mutations associated with NRTIs were summarized at time of failure: Any zidovudine/lamivudine (Zid/Lam), Any thymidine analogue-associated mutation (TAM), methionine (M) to valine/isoleucine (V/I) substitution at residue (r) 184 (M184V/I), lysine (K) to arginine (R) substitution at residue 65 (K65R) and any other NRTI mutations.|Screening, time of failure through Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘n’ is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively.||participants|||Number
173349|NCT00098254|Secondary|Overall Survival|Time between the first day of treatment to the days of death.|17 months|||months||95% Confidence Interval|Median
173350|NCT00098254|Primary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 1/2 years|||Participants|||Number
173325|NCT00098293|Secondary|Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96|Phenotypic resistance to nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) assessed at screening by Monogram Bioscience PhenoSense genotype (MBPSGT) assay, repeated if viral load >500 copies/mL at treatment failure through week 48, 96. Phenotypic resistance to maraviroc was assumed in maraviroc treatment failures with X4-using virus and in R5 maraviroc treatment failures using Monogram Bioscience PhenoSense Entry Assay. Phenotypic resistance to zidovudine, lamivudine, efavirenz and maraviroc at time of failure was summarized.|Screening, time of failure through Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘n’ is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively.||participants|||Number
173326|NCT00098293|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96|Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 96 visit. Treatment failure defined as insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as BLQ. The assessment for time of treatment failure was defined as last on treatment assessment.|Baseline, time of failure through Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
173327|NCT00098293|Secondary|Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48|Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure: discontinuation due to insufficient clinical response. Tropism result was censored for participants with viral load <500 copies/mL at time of treatment failure categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as last on treatment assessment.|Baseline, time of failure through Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. ‘N’ (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline.||participants|||Number
173328|NCT00098293|Secondary|Time to Virologic Failure|Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up [LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL(2 consecutive visits);failure if level >=400 copies/mL(2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.|Week 48, Week 96|FAS population; Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.||days||95% Confidence Interval|Median
173329|NCT00098293|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96|Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. Change from baseline in lymphocyte CD8 count at Week 48 and 96 was not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Baseline, Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells/µL||Standard Deviation|Mean
173330|NCT00098293|Secondary|Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96|Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.|Baseline, Week 48, Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF.||cells per microliter (cells/µL)||Standard Deviation|Mean
173331|NCT00098293|Secondary|Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels|TAD from baseline was calculated as area under the curve (AUC) of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Baseline up to Week 48 and Week 96|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. TAD imputed as 0 for participants who discontinued. TAD calculated using the last non-missing value prior to the analysis time point for participants with a missing value at the analysis time point but who had not discontinued.||log10 copies/mL||Standard Error|Least Squares Mean
173332|NCT00098293|Secondary|Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96|Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.|Baseline, Week 48, Week 96|FAS population. Missing values for viral load at week 48 and 96 were imputed as baseline value for participants who discontinued and as last observation carried forward (LOCF) for participants who did not discontinue for maraviroc twice daily and efavirenz once daily arm and as LOCF for participants randomized to maraviroc once daily arm.||log10 copies/mL||Standard Deviation|Mean
173351|NCT00098254|Primary|Progression Free Survival|"Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions.~Appearance of one or more new lesions and/or unequivocal progressions of existing non-target lesions."|17 months|||months||95% Confidence Interval|Median
173334|NCT00098293|Secondary|Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression||Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
173335|NCT00098293|Primary|Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population|Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.|Week 48|Per protocol (PP) population included all randomized participants who had taken at least 1 dose of study medication, were treated for at least 14 days or discontinued before this time due to treatment failure, were >80% compliant with randomized treatment and had no violation of any inclusion or exclusion criteria, which affected efficacy. MD=F.||Percentage of participants|||Number
173336|NCT00098293|Primary|Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population||Week 48|FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).||Percentage of participants|||Number
173337|NCT00098254|Secondary|Secondary Pharmacoproteomic Modulation Targets|Secondary pharmacoproteomic modulation targets (mTOR, EGFR, Src, NFkB, STAT1, TGFa, p38, Jak 1, lkB, IGFR, p-mTOR, p-EGFR, p-Src, p-NFkB, p-STAT1, Phospho-p38, p-Jak1, p-lkB,Pyk2, p-Pyk2, VEGFR-2, GSK3beta, p-GSK3beta, p-bad, p-Bcl-2, PCNA, Fos, Raf, CREB, Rho, avbeta3complex, Bad, CD34, VEGFR-1, bfGF, vWF, Factor VIII, Annexin V, Bcl-2).|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.||mg/ml|||Number
173338|NCT00098254|Secondary|Percent of Pts With Primary Pharmacoproteomic Modulation Targets|Pharmacoproteomic modulation targets (AKT, p-AKT, ERK 1/2, MEK, Cyclin D, p-ERK 1/2, p-MEK, pMEK, eNOA, p-eNOA, Cleaved PARP, PDGFRbeta, p-PDGFRbeta,Cyclin D, CD31, PARP. Caspase 9, Caspase 3, Cleaved Caspase-9 Cleaved Caspase 3)|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.||mg/ml|||Number
173339|NCT00098254|Secondary|Percentage of Participants With BRAF Mutations|Extracted DNA was subjected to an initial PCR using a single primer set encompassing codom V600. Pyrosequencing was carried out on a Qiagen PyroMaark Q24 system.|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.||Percent of participants|||Number
173340|NCT00098254|Secondary|Percent of Participants Who Had Cytokine Profiling for IL-6 and IL-8|Serial plasma samples were collected from all patients at pretreatment (baseline - day 0), and on days 14, 28, and 54. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).|60 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.||Percent of participants|||Number
173341|NCT00098254|Secondary|Percent of Participants Who Had Immunohistochemical Analysis Performed for Raf, MEK, ERK, ERK-1 and p90RSK,ERK, E Twenty-six (ETS)-Like Transcription Factor 1 (ELK-1) and p90Ribosomal S6 Kinase (p90RSK).|Immunohistochemical analysis performed by using state specific antibodies against Raf, methyl ethyl ketone (MEK), extracellular-signal regulated kinase (ERK), and two downstream substrates of ERK, E twenty-six (ETS)-like transcription factor 1 (ELK-1) and p90Ribosomal S6 kinase (p90RSK).|59 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to br more important.||Percent of participants|||Number
173342|NCT00098254|Secondary|Percentage of Participants With an Increase or Decrease in the Reverse Contrast Transfer Rate (Kep), Forward Contrast Transfer Rate (Ktrans), and Extravascular Fraction (Ve) With the Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)|DCE-MRI was used to evaluate changes (e.g. decrease/increase in Ve, Ktrans, Kep value) in vascularity and quality of index lesions to provide early indication of treatment effect before changes in size can be perceived on CT. Changes were reflected in a decrease/increase of Ve, Ktrans, or Kep (Kep, Ve, Ktrans measurements at day 0, day 14 and the difference between the day 14 and the day 0 measurements (day 14-day 0).|59 months|||Percentage of participants|||Number
173343|NCT00098254|Secondary|Progression Free Survival Associated With Basic Fibroblast Growth Factor (bFGF)|Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).|17 months|||months||95% Confidence Interval|Median
173344|NCT00098254|Secondary|Overall Survival Associated With Basic Fibroblast Growth Factor (bFGF)|Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).|42 months|14 patients with day 28 FGF >6 and 14 patients with FGF <6.||months||95% Confidence Interval|Median
173345|NCT00098254|Secondary|Correlation of Response to Treatment With KRAS Mutational Status|Mutational analysis of these genes was performed on paraffin-imbedded tissue blocks from prior pathologic specimens. Disease control rate was correlated with KRAS mutational status. Disease control rate was defined as complete remission (CR) + partial remission (PR)+ stable disease (SD).|42 months|11/34 KRAS positive; 23/34 KRAS negative 5/23 EGFR positive; 18/23 EGFR negative||percentage of participants|||Number
173346|NCT00098254|Secondary|Cytokine Levels|Serial plasma samples were collected from all patients and cytokine levels were measured. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).|54 days|||pg/ml||Inter-Quartile Range|Median
173347|NCT00098254|Secondary|Overall Survival Reported Separately for Participants With a Change in PLGF Below 11 pg/ml and Above 12 pg/ml|Difference in placental derived growth factor (PLGF) between day 28 and day 0 of < 11 pg/ml vs. > 12 pg/ml.|17 months|||months||95% Confidence Interval|Median
173348|NCT00098254|Secondary|Percent of Participants With Genotyping of CYP3A4/5 and 5 Polymorphisms|All patients will be genotyped for CYP3A4/5 and 5 polymorphisms.|58 months|The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.||Percent of participants|||Number
173352|NCT00098254|Primary|Response Rate|Percentage of participants with response rate = CR + PR. Response will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR (complete response) is the disappearance of all target lesions; PR (partial response) is a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) is a 20% increase in the sum of the longest diameter of target lesions; and SD (stable disease) are small changes that do not meet the above criteria. Please see the Protocol Link module for additional information about RECIST if desired.|17 months|||percentage of participants||95% Confidence Interval|Number
173353|NCT00097370|Secondary|Change From Baseline in QoL and Current Health Status: Mental Summary Score of the SF12 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey developed by the Medical Outcomes Trust and QualityMetric Incorporated. It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 scale questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health are for mental component summary. Transformed mental component summary score (MCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Scores on a scale||Standard Deviation|Mean
173354|NCT00097370|Secondary|Change From Baseline in Quality of Life (QoL) and Current Health Status: Physical Summary Score of the Study Short Form Health Survey (SF-12) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The SF-12v2 is the 12 item abbreviated form of SF-36v2 survey . It provides information about how participants feel, and how well they have been able to perform their usual activities, over the past 4 weeks. SF-12v2 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS-12) is derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. Change from Baseline in scale or summary measure score is the difference between the score at the time point being analyzed to Baseline.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Scores on the scale||Standard Deviation|Mean
173355|NCT00097370|Secondary|Change From Baseline in Erythema/Edema Score 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The erythema subscale score and edema subscale score are each graded on a 0-3 scale, with 0 = absent , 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 6, with higher scores indicative of more severe Erythema/Edema. The total score was obtained by summing together the responses for each of the two subscale items. Change from Baseline in erythema/edema total score is the difference between erythema/edema total score at the time point being analyzed to the MHE100901 Baseline score..|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Scores on a scale||Standard Deviation|Mean
173356|NCT00097370|Secondary|Change From Baseline in the Pruritus Visual Analogue Scale (pVAS) 3 Months After the Start of Study MHE100901 and Every 6 Months Thereafter|The pruritus visual analogue scale asks participants to rate the status of their Pruritus based on the severity of their itch. Scores range from 0-100 with 0 = No itch and 100 = Worst imaginable itch. Change from Baseline in pVAS score is the difference between the pVAS score at the time point being considered to the MHE100901 Baseline score.|Baseline and up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Scores on the scale||Standard Deviation|Mean
173357|NCT00097370|Secondary|Number of Participants by Dosing Frequency Groups (Defined as Two Week Dosing Ranges Greater Than a 4 Week Interval) at the End of Stage 2|The number of participants at the end of Stage 2 with study medication dosing frequencies of 4 weeks, 5-6 weeks, 7-8 weeks, 9-10 weeks, 11-12 weeks, 13-16 weeks, 17-20 weeks, 21-24 weeks and >24 weeks were summarized. The first infusion date in Stage 3 and the last infusion date in Stage 2 were used to calculate the dosing frequency.|up to approximately 6 years|ITT Population. Only those participants available at end of Stage 2 were included.||Participants|||Number
173358|NCT00097370|Secondary|Blood Eosinophil Count (With Consideration of the HES Background Therapy) During Stages 1-3|Mean blood eosinophil counts were summarized over time taking into account the effect of HES background therapy. Eosinophil count observations for only those participants taking mepolizumab in conjunction with prednisone or as monotherapy were included.|up to approximately 6 years|ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).||Cell/uL||Standard Deviation|Mean
173359|NCT00097370|Secondary|For Those Participants Who Entered Stage 1 From Study MHE100185 With >10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for>=3 Months|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of >10 mg prednisone at the end of the study and participants who withdrew from the study early who were at a prednisone dose level >10 mg were analyzed. Duration of doses <= 10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they do not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months)|up to approximately 6 years|ITT Population. Only those participants who entered Stage 1 from study MHE100185 with >10 mg prednisone were analyzed.||Participants|||Number
173400|NCT00097721|Secondary|Duration of Response|Measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent progressive disease was objectively documented (taking as a reference for progressive disease the smallest measurements recorded since the treatment started).|From CR or partial response PR (whichever recorded first) to date of recurrent or progressive disease|Intent to Treat/Safety Population (Investigator Assessment)||days||Full Range|Median
173360|NCT00097370|Secondary|For Those Participants Who Entered Stage 2 From Study MHE100185 With a Prednisone Level of <=10 mg Prednisone: Number of Participants Achieving a Prednisone Dose <=10 mg (as Sole Background Therapy) for >=3 Months;|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end and participants who withdrew from the study early who were at a prednisone dose level <=10 mg were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overlap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months).|up to approximately 6 years|ITT Population. Only those participants who entered Stage 2 from study MHE100185 with a prednisone level of <=10 mg prednisone were analyzed.||Participants|||Number
173361|NCT00097370|Secondary|For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level >10 mg: Number of Participants Achieving <=10 mg Prednisone (as Sole Background Therapy) for >= 8 Weeks|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of prednisone of >10 mg at the end of the study were analyzed. Duration of doses <= 10 mg were determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If overap occurred, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 53 days (8 weeks).|up to approximately 6 years|ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level >10 mg were analyzed.||Participants|||Number
173362|NCT00097370|Secondary|For Those Participants Who Completed 9 Months of Dosing in Study MHE100185 and Achieved a Prednisone Level <=10 mg: Number of Participants Achieving <= 10 mg Prednisone (as Sole Background Therapy) for >= 3months|Participants from study MHE100185 who completed the 9 months treatment period and achieved a level of <=10 mg of prednisone at study end were analyzed. Duration of doses <=10 mg was determined by examining changes in the prednisone dosing or allowable alternative corticosteroid medication (prednisone equivalents). Start and stop dates of other HES medications were checked to ensure that they did not overlap with the steroid dosing dates. If it did, then the number of days <=10 mg during this overlap was considered as zero and the cumulative days reset to zero, as the endpoint was assessing prednisone dose as sole background therapy. The dosing criteria for this endpoint was considered as achieved if the duration of dosing was minimum of 84 days (3months).|up to approximately 6 years|ITT Population. Only those participants who completed 9 months of dosing in study MHE100185 and achieved a prednisone level <=10 mg were analyzed.||Participants|||Number
173363|NCT00097370|Secondary|Number of Participants Achieving an Eosinophil Level of < 600 Cell/Microliter (uL) (in Addition to the Lowest Background Therapy) at the End of Study|The criteria for eosinophil count was achieved if the participant's eosinophil count remained below <600 cell/uL for the last observation on study i.e. within length of dosing cycle + 7 days of last dose of study drug. For participants who entered in Stage 1, HES medications taking prior to the first infusion date in Stage 2 were considered as the lowest background therapy. For participants who entered in Stage 2, HES medications taken on the date that immediately preceded the first infusion date of study drug and had not been discontinued was regarded as the lowest background therapy. If the dose of the lowest background therapy had increased or the medication had changed or the participant had not reached their lowest background therapy, the participant was regarded as not achieving this endpoint.|up to approximately 6 years|ITT Population||Participants|||Number
173364|NCT00097370|Secondary|Number of Participants Achieving a Prednisone Level of =<10 mg (as Sole Background Therapy) at the End of Study|Participants who were receiving a prednisone dose level of =<10 mg as their sole background therapy at the end of the study were included for the analysis.|up to approximately 6 years|ITT Population||Participants|||Number
173365|NCT00097370|Primary|Number of Participants With Any Adverse Event (AE) During the Follow-up Phase|An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Follow-up phase. Safety and tolerability of the study drug was assessed by number of participants with any AE|From end of Treatment Phase up to 97 days after the last dose date (up to approximately 6 years)|Follow-up Population: subset of the modified ITT Population who had evidence of being in the study > length of dosing cycle + 7 days after the date of their last dose of study medication and up to and including 97 days after their last dose date.||Participants|||Number
173366|NCT00097370|Primary|Number of Participants With Any Adverse Event (AE) During the Treatment Phase|An AE is any untoward medical occurrence in clinical investigation participants temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs are summarized by Treatment phase. Safety and tolerability of the study drug was assessed by number of participants with any AE|From the first dose of study medication up to 7 days after the last dose (up to approximately 6 years)|Intent-to-Treat (ITT) Population: all enrolled participants who received at least one dose of mepolizumab in this study.||Participants|||Number
173367|NCT00097253|Primary|Immune Function: Delayed Hypersensitivity to Candida(DTH)|DTH memory responses to a common infectious agent provided a measure of T-cell immunity. Nurses inoculated subject's arm with 0.1ml Candida (stock solution diluted 1:20 in saline, Greer Labs, NC) intradermally, after the cold pressor stressor. The wheal diameter (2 dimensions) was self-assessed at 24, 48, and 72 hours by participants given detailed instructions and templates for measurement.|Day 1 11:45, Day 2 (24h) 11:45, Day 3 (48h) 11:45, Day 4 (72h) 11:45.|||mm^2||Standard Deviation|Mean
173446|NCT00096785|Secondary|Change From Baseline in HBV DNA by PCR Assay at Week 48|Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 48, adjusted for baseline (Week 48 - Baseline). A negative value = improvement.|Baseline, Week 48|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||log10 c/mL||Standard Error|Mean
173368|NCT00097253|Primary|Skin Barrier Repair|TEWL (Transepidermal Water Loss, via tape stripping procedure)measured before and after cold pressor stressor (11:00). After obtaining baseline measurements on volar forearm, cellophane tape(3M Scotch-type; St. Paul, MN) was applied repeatedly (6–50 times) to remove superficial layer of cornified skin cells. Tape stripping stopped when TEWL was elevated from the basal level of 5–7 g/h/m2 to at least 20 g/h/m2. The number of strips required to reach TEWL X20 g/m2/h was the measure of barrier. TEWL was measured with a computerized evaporimetry instrument, the DermaLabs (CyberDERM, Media, PA).|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4).10:05, 11:45, 13:15|||number tape strips||Standard Deviation|Mean
173369|NCT00097253|Primary|Immune Function|Stimulated Cytokine Production (Interleukin-6 (IL-6), Interleukin-10 (IL-10)) measured before and after cold pressor stressor, which occurred at 11:00.|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). 9:05, 10:05, 11:45|||pg/ml||Standard Deviation|Mean
173370|NCT00097253|Primary|Cortisol and Catecholamine Production|Cortisol, norepinephrine, epinephrine measured before and after physical (cold pressor) stressor, which occurred at 11:00.|3 Visits with at least 2 weeks between each. Average time to complete all visits was 64.46 days (SD 48.4). Cortisol: 9:05, 10:05, 10:55, 11:45, 12:15, 13:00. Nor/Epi: 9:05, 10:05, 10:55, 11:05, 11:45, 12:15|||pg/ml (log 10)||Standard Deviation|Mean
173371|NCT00098059|Primary|Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.|A patient with multiple AEs within the primary system organ class is counted only once in total row.|Administered 2 times daily over 7 days|Includes 47 patients enrolled in Part B of the study.||participants|||Number
173372|NCT00098059|Primary|Apparent Terminal Elimination Half-life of Penciclovir (T1/2)|PK parameter; penciclovir is the active metabolite of famciclovir|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.||hours||Full Range|Mean
173373|NCT00098059|Primary|Apparent Oral Clearance of Penciclovir (CL/F)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.||L/h||Full Range|Mean
173374|NCT00098059|Primary|Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes 26 of 27 patients enrolled in Part A of the study.||(μg/mL)h||Full Range|Mean
173375|NCT00098059|Primary|Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)|PK parameter; penciclovir is the active metabolite of famciclovir.|Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes all 27 patients enrolled in Part A of the study.||hours||Full Range|Median
173376|NCT00098059|Primary|Maximum Observed Plasma Concentration of Penciclovir (Cmax)|PK parameter; penciclovir is the active metabolite of famciclovir.|plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose|Includes all 27 patients enrolled in Part A of the study.||μg/mL||Full Range|Mean
173377|NCT00098059|Primary|Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.|A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.|8 hours and 24 hours after study drug administration (Part A)|Includes all 27 patients enrolled in Part A of the study.||participants|||Number
173378|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study|Overall acceptability of study medication was determined by caretaker response.|Day 8 at home: after swallowing last dose|Includes all 47 patients enrolled in Part B of the study. Response was not available for 1 patient in the 2 to <6 years and 6 to <=12 years groups.||participants|||Number
173379|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.|Overall acceptability of the study medication was determined by caretaker response.|Day 1 at clinic: after swallowing first dose|Includes all 47 patients enrolled in Part B of the study.||participants|||Number
173380|NCT00098059|Secondary|Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.|Overall acceptability of the study medication was determined by caretaker response.|Day 1, after swallowing the dose.|Includes all 27 patients enrolled in Part A of the study.||participants|||Number
173381|NCT00097981|Secondary|Engraftment: Number of Participants Who Underwent Engraftment|Engraftment is the process of transplanted stem cells reproducing new cells.|From randomization until death or as assessed up to 2 years post last participant last treatment visit||09/2010||||
173382|NCT00097981|Secondary|Transplantation: Number of Participants Who Underwent Transplantation (Peripheral Stem Cell / Bone Marrow)||From randomization until death or as assessed up to 2 years post last participant last treatment visit||09/2010||||
173383|NCT00097981|Secondary|Overall Survival: Number of Participants Died Due to Any Cause||From randomization until death or as assessed up to 2 years post last participant last treatment visit|Intent-to-treat: Participants who were randomized to receive the treatment.||Participants|||Number
173384|NCT00097981|Secondary|Time to Progression|Time to progression is the interval between the date of randomization until disease progression or death due to progression.|From randomization until death or as assessed up to 2 years post last participant last treatment visit||09/2010||||
173385|NCT00097981|Secondary|Time to 1st Response|Time to first response was defined as the interval from date of randomization to date of achieving a partial response (PR) or better according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.||Days||95% Confidence Interval|Median
173386|NCT00097981|Secondary|Overall Response: Number of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)|Overall response to study medication is defined as number of participants who acheived a complete response (CR) or partial response (PR) by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions; and PR is defined as not all CR criteria + 50 percentage or more reduction in serum monoclonal paraprotein.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.||Participants|||Number
173387|NCT00097981|Primary|Complete Response Rate: Number of Participants Who Achieved a Complete Response|Complete response rate to study medication is defined as number of participants who acheived complete response by the local investigator according to the current European Group for Blood and Marrow Transplantation (EBMT) criteria. According to EBMT criteria, CR is defined as the absence of serum and urine monoclonal paraprotein + plus no increase in size or number of lytic bone lesions. Complete response was assessed at the beginning of every treatment cycle prior to treatment, starting at Cycle 2.|From Cycle 2 until 28 days following completion of treatment|Intent-to-treat: Participants who were randomized to receive the treatment.||Participants|||Number
173388|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide|The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|Mean patient duration of 5.8 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
173389|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Nateglinide Versus Non-nateglinide|The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.|Mean patient duration of 5.6 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
173390|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Nateglinide Versus Non-nateglinide|Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.|Mean patient duration of 4.2 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
173391|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Core Cardiovascular Morbidity and Mortality Event - Valsartan Versus Non-valsartan|The core cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for congestive heart failure.|Mean patient duration of 5.8 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
173392|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Extended Morbidity and Mortality Event - Valsartan Versus Non-valsartan|The extended cardiovascular endpoint was defined as a cardiovascular morbidity/mortality event including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularization procedure, hospitalization for congestive heart failure, and hospitalization for unstable angina.|Mean patient duration of 5.6 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
173393|NCT00097786|Primary|Percentage of Patients Reaching the Endpoint: Progression to Diabetes - Valsartan Versus Non-valsartan|Progression to diabetes was determined by (a) an algorithm based on central laboratory measurements of fasting plasma glucose and/or a 2 hour oral glucose tolerance test or (b) adjudication by the Diabetes Endpoint Adjudication Committee.|Mean patient duration of 4.2 years|Full Analysis Set: All patients in the randomized set with the exception of patients from 10 Mexican sites closed for severe Good Clinical Practice deficiencies.||Percentage of patients|||Number
173394|NCT00097773|Secondary|Number of Participants With a Pulmonary Exacerbation Requiring Oral, Inhaled, or Oral Antibiotics|"The primary comparison is between the pooled culture-based group and the pooled cycled group. No interactions with ciprofloxacin were identified. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups.~Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns."|Measured over the 18 month time period|Intent to treat||participants|||Number
173395|NCT00097773|Secondary|Proportion of Participants With a Pa Positive Culture|"Proportion of participants with a Pa positive culture compared between (1) the pooled cycled therapy group (n=152) and pooled culture-based therapy group (n=152), and (2) between the pooled oral placebo (n=152)and pooled cipro groups (n=152).~Participants are included once in the cycled and culture-based columns, and once in the oral cipro and placebo columns"|Week 10 (after initial treatment course for Pa) through Month 18|Intent to treat||Participants|||Number
173396|NCT00097773|Primary|Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization|"The primary comparison is between the pooled culture-based group and the pooled cycled group. A secondary comparison is between the pooled ciprofloxacin group vs the pooled placebo group. Descriptive results are provided for the pooled treatment groups.~Participants are represented once in the cycled and culture-based therapy columns, and once in the cipro and placebo columns."|Measured over the 18 month study|Intent to treat||number of participants|||Number
173397|NCT00097721|Secondary|Change From Baseline to Study Termination in Quality of Life Measures Using Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores|The FACT-B questionnaire consists of 36 questions each scored from 0-4. The total score is calculated by summing these scores. The total possible range is from 0 to 144. The higher scores indicate a better health-related quality of life. This measures emotional, functional, physical, and social well being as well as concerns specific to patients with breast cancer.|At Screening, Day 1 of each cycle, and 30 days after last dose of study drug|||units on a scale||Full Range|Median
173398|NCT00097721|Secondary|Overall Survival|Defined as the time from the start of study drug administration until death from any cause|From start of study drug administration to death|Per Protocol Population (Investigator Assessment)||days||Full Range|Median
173399|NCT00097721|Secondary|Progression Free Survival|Defined as the time from start of study drug administration until progressive disease or death from any cause during the study period in the absence of disease progression.|From start of study drug administration to progressive disease or death|Per Protocol Population (Investigator Assessment)||days||Full Range|Median
173401|NCT00097721|Primary|Overall Response Rate Based on Response Evaluation Criteria in Solid Tumors (RECIST)|Defined as the percentage of subjects with CR or PR from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).|Confirmed 4 to 8 weeks after first observed|Per Protocol Population (Independent Reviewer Assessment)||percentage of participants|||Number
173402|NCT00097708|Primary|Change in HAM-A Total Score|Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.|Baseline to week 8|||Units on a Scale||Full Range|Least Squares Mean
173403|NCT00097695|Secondary|Time to Almost Complete Symptom Relief|The time to almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least 3 consecutive measurements for all symptom.|5 days|||Hours||Inter-Quartile Range|Median
173404|NCT00097695|Secondary|Time to Regression (Start of Improvement) According to Patient|"This parameter assessed the time to regression (start of improvement) of observable(visible) symptoms according to the patients. Patients were asked Report date and time when you feel that your symptoms start to improve."|5 days|||Hours||Inter-Quartile Range|Median
173405|NCT00097695|Primary|Time to Onset of Symptom Relief (TOSR)|"The primary efficacy endpoint was TOSR assessed by the patient using a Visual Analogue Scale (VAS). The VAS is a scale used to measure intensity of each symptom of the attack at baseline and at the pre-determined time points throughout treatment period. It consists of a horizontal 10cm line, with the 0 point corresponding to a state where patient experiences no symptoms at all and the 10cm point represents the worst symptoms ever experienced by patient. The patient indicates his/her current state of symptoms by drawing a mark across the horizontal line.~TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the 3 primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain.~The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe."|5 days|Time to onset of symptom relief - Controlled phase - ITT population (patients experiencing moderate to very severe acute cutaneous and/or abdominal HAE attacks)||Hours||Inter-Quartile Range|Median
173406|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of All-Cause Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of all-cause death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population.|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.||Participants|||Number
173407|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, or Rehospitalization for Cardiac Ischemic Events|The endpoint in this measure is a combination of CV death, nonfatal MI, nonfatal stroke, or rehospitalization for cardiac ischemic events. Results are reported for the All ACS population.|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.||Participants|||Number
173408|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. Results are reported for the All ACS population for the 30 and 90 day periods.|Randomization to 30 days; randomization to 90 days|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.||Participants|||Number
173409|NCT00097591|Secondary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Urgent Target Vessel Revascularization (UTVR)|The endpoint in this measure is a combination of CV death, nonfatal MI, or UTVR. Results are reported for the All ACS subject population for the 30 and 90 day periods.|Randomization to 30 days; randomization to 90 days|Intention-to-treat (ITT) population consisting of all randomized All ACS subjects who may or may not have received study drug.||Participants|||Number
173410|NCT00097591|Secondary|Number of Treated Subjects With Non-Coronary Artery Bypass Graft (CABG) Related Thrombolysis In Myocardial Infarction (TIMI) Study Group Major and Minor Bleeding Events|TIMI classification for major and minor bleeding in the subset of subjects who did not undergo a coronary artery bypass operation (CABG) were defined as follows: Major bleeding: any intracranial hemorrhage (ICH) OR any clinically overt bleeding (including bleeding evident on imaging studies) associated with a fall in hemoglobin (Hgb) of ≥5 grams/deciliter (gm/dL)from baseline. Minor Bleeding: any clinically overt bleeding associated with a fall in Hgb of ≥3 gm/dL but <5 gm/dL from baseline. Major bleeding events were further examined as events that were deemed life threatening and/or fatal.|First dose of study drug up to 15 months (while at risk)|Treated subjects with adverse events were considered “at risk” from the first dose of study drug up through 7 days after permanent study drug discontinuation, or the subjects’ discontinuation visit; or from randomization through 464 days, whichever is earlier. Adverse events classified as “study drug related” were included in the “at risk” set.||Participants|||Number
173411|NCT00097591|Primary|Number of Subjects Reaching the Composite Endpoint of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), or Nonfatal Stroke|The endpoint in this measure is a combination of CV death, nonfatal MI, or nonfatal stroke. The data is presented by the study population, which is represented as follows: 1) subjects who presented with unstable angina and non-ST-segment elevation myocardial infarction (UA/NSTEMI), 2) subjects who presented with ST segment elevation myocardial infarction (STEMI), and 3) all subjects with acute coronary syndromes (ACS) (i.e. all subjects with UA/NSTEMI or STEMI).|Randomization up to 15 months|Intention-to-treat (ITT) population consisting of all subjects with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) who may or may not have received study drug||Participants|||Number
173469|NCT00096278|Secondary|Proteinuria With Clinical Sequelae||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months||||||
173412|NCT00097539|Primary|Near Adult Height (NAH)|Heights were standardized with height standardized deviation scores (SDS) to enable height comparisons across ages and sexes using methods and height standards found at: http://www.cdc.gov/growthcharts/cdc_charts.htm. NAH were calculated overall and by etiology groups for participants who had both a non-missing value available height z-score and a non-missing enrollment height (EH) SDS, as well as for participants with 3 or more years of GH therapy (GHT ≥3y).|From October 1985 to June 2010 (overall approximately 24 years and 9 months)|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.||SDS||Standard Deviation|Mean
173413|NCT00097539|Primary|Third Year Annualized Growth Rate|Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 730 days after baseline to the visit closest to 1095 days. Visits within 90 days of 730 and 1095 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 730 or 1095 days was used. Growth rates <-1 or >30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing third-year growth rate data were included in the analysis.|Year 3|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.||cm/yr||Standard Deviation|Mean
173414|NCT00097539|Primary|Second Year Annualized Growth Rate|Annualized growth rates are expressed as cm/yr, computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the visit closest to 365 days after baseline to the visit closest to 730 days. Visits within 90 days of 365 and 730 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365 or 730 days was used. Growth rates <-1 or >30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing second-year growth rate data were included in the analysis.|Year 2|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.||cm/yr||Standard Deviation|Mean
173415|NCT00097539|Primary|First Year Annualized Growth Rate|Annualized growth rates are expressed as centimeters per year (cm/yr), computed as the change in height (centimeters) divided by the change in age (years). Growth rates were calculated from the date of the first injection (baseline/ enrollment) to the visit closest to 365*1 days after baseline. Visits within 90 days of 365*1 days after baseline may be used. If multiple visits within 90 days were reported then the visit closest to 365*1 days was used. Growth rates less than (<) -1 or greater than (>) 30 cm/yr were excluded. Growth rates from -1 to 0 were set to 0 cm/yr. Growth rates are summarized by etiology group and gender. Only those participants who had non-missing 1-year growth rate data were included in the analysis.|Year 1|Safety evaluable population. Here, 'N' (number of participants analyzed) signifies the number of participants evaluable for this outcome measure and 'Number Analyzed' signifies the number of participants evaluable for specified category.||cm/yr||Standard Deviation|Mean
173416|NCT00097539|Primary|Number of Participants Who Died||From October 1985 to June 2010 (overall approximately 24 years and 9 months)|Safety evaluable population||participants|||Number
173417|NCT00097500|Secondary|M-value at Baseline, Week 52 and Week 56|M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.|baseline (week -2), 52 weeks, and 56 weeks|Evaluable population.||mg/min/kg||Standard Error|Mean
173418|NCT00097500|Secondary|Change in Body Weight|Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).|0 weeks and 52 weeks|Intent to treat population. Last observation carried forward.||kg||Standard Error|Least Squares Mean
173419|NCT00097500|Secondary|Seven Point Self Monitored Blood Glucose (SMBG) Measurements|SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).|0 weeks and 52 weeks|Intent to treat population.||mmol/L||Standard Deviation|Mean
173420|NCT00097500|Secondary|Change in Fasting Plasma Glucose|Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).|0 weeks and 52 weeks|Intent to treat population. Last observation carried forward.||mmol/L||Standard Error|Least Squares Mean
173421|NCT00097500|Secondary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).|Week 0 and week 52|Intent to treat population. Last observation carried forward.||percent||Standard Error|Least Squares Mean
173422|NCT00097500|Secondary|Change in Second Phase C-peptide Release|Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.|baseline (-2 weeks), 52 weeks, and 56 weeks|Evaluable population. Last observation carried forward.||ratio||Standard Error|Least Squares Mean
173423|NCT00097500|Secondary|Change in First Phase C-peptide Release|Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.|baseline (week -2), 52 weeks, and 56 weeks|Evaluable population. Last observation carried forward.||ratio||Standard Error|Least Squares Mean
173470|NCT00096278|Secondary|Proteinuria After Completion of Bevacizumab||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months||||||
173424|NCT00097500|Secondary|Beta-cell Function 4 Weeks After Cessation of Therapy|Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline [week -2]).|Baseline (week -2) and 56 weeks|Evaluable population||ratio||Standard Error|Least Squares Mean
173425|NCT00097500|Primary|Beta-cell Function After 52 Weeks of Therapy|Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline [week -2]).|Baseline (week -2) and 52 weeks|Evaluable population||ratio||Standard Error|Least Squares Mean
173426|NCT00097448|Primary|Hearing Improvement|Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.|2 months|Intention-to-treat||dB||Standard Deviation|Mean
173427|NCT00096993|Secondary|Duration of Survival|Duration of survival was defined as the time from randomization until death from any cause.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
173428|NCT00096993|Secondary|Percentage of Participants Free From Disease Progression at 4 Months|Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to Month 4|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.||percentage of participants|||Number
173429|NCT00096993|Secondary|Duration of the Objective Response|Duration of the objective response was defined as the time from the initial response to disease progression or death from any cause.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication. Only participants with an objective response were included in the analysis.||months||95% Confidence Interval|Median
173430|NCT00096993|Secondary|Percentage of Participants With an Objective Response|An objective response was defined as a complete or partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors (RECIST). A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.||percentage of participants|||Number
173431|NCT00096993|Primary|Progression-free Survival|Progression-free survival was defined as the time from the first day of treatment (Cycle 1, Day 1) to the time of documented disease progression or death, whichever occurred first. Disease progression was assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) was defined as disappearance of all target lesions; Partial Response (PR) was defined as >=30% decrease in the sum of the longest diameter of target lesions and Overall Response (OR) = CR + PR.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: All randomized participants who received at least 1 dose of study medication.||months||95% Confidence Interval|Median
173432|NCT00096954|Secondary|Relative Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 24|"Spirometry was used to assess FEV1. All spirometry measurements were performed in accordance with the American Thoracic Society (ATS) guidelines.~The relative percent change from baseline in forced expiratory volume (liters) in one second (FEV1) was calculated at week 24 using the formula: (FEV1 at week 24 - FEV1 at baseline) / FEV1 at baseline * 100 for each treatment group."|Baseline and 24 weeks|Modified Intent-to-Treat. Patients with missing FEV1 data at either baseline or week 24 were excluded.||percent change||Standard Deviation|Mean
173433|NCT00096954|Secondary|Change From Baseline in Nocturnal and Daytime Asthma Symptom Scores at Week 24|"The daytime asthma symptom score assessed the symptoms: shortness of breath, chest discomfort, wheezing, and cough over the previous 24 hour period on a scale of 0(no symptoms) to 4(marked discomfort).~The nocturnal asthma score was the patient's response to:How did you sleep last night? rated on a scale of 0(no problems) to 4(difficulty sleeping;rescue medicine used).~Scores were collected daily. Change from Baseline (mean of last 28 days prior to first dosing date) at Week 24 (mean of last 28 days prior to week 24 visit).~A negative change from baseline score indicates improvement."|Baseline and 24 weeks|Modified Intent-to-Treat. Patients with missing Asthma Symptom Score data at week 24 were excluded.||score on a scale||Standard Deviation|Mean
173434|NCT00096954|Secondary|Number of Participants Experiencing One or More Protocol-defined Asthma Exacerbations During the Treatment Period|The number of patients reporting one or more protocol-defined asthma exacerbations during the 24 week treatment period. A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.|Start of treatment to 24 weeks|Modified Intent-to-Treat - All randomly assigned patients who received at least 1 dose of study drug (omalizumab or placebo).||participants|||Number
173435|NCT00096954|Primary|Rate of Asthma Exacerbations Over the 24 Week Treatment Period|"A protocol-defined asthma exacerbation was a worsening of asthma requiring treatment with oral or intravenous corticosteroid burst and/or a doubling of the baseline inhaled corticosteroids (ICS) dose for at least 3 days.~The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 week treatment period in each treatment group."|Start of treatment to 24 weeks|Modified Intent-to-Treat - All randomly assigned patients who received at least 1 dose of study drug (omalizumab or placebo).||exacerbations per 24 patient-week period|||Number
173471|NCT00096278|Secondary|Survival as Assessed by Death From Any Cause||Every 6 months for 4 years and then every 12 months until death from any cause||||||
173472|NCT00096278|Primary|Disease-free Survival|Where events are defined as recurrence, second primary cancer, or death from any cause|3 years|||percentage of patients|||Number
173436|NCT00096941|Secondary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 2 years, 5 months)|Safety population: Participants who received at least 1 dose of pertuzumab.||percentage of participants|||Number
173437|NCT00096941|Primary|Percentage of Participants Who Experienced an Adverse Event||Baseline to the end of the study (up to 2 years, 5 months)|Safety population: Participants who received at least 1 dose of pertuzumab. Percentage of participants||percentage of participants|||Number
173438|NCT00096785|Secondary|Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs|Laboratory abnormalities reported as clinical AEs|Week 48|As-treated population. 1 participant who was randomized to ADV, but treated with ETV was counted in the ETV group.||Participants|||Number
173439|NCT00096785|Secondary|Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths|AE=new untoward medical occurrence or worsening of pre-existing medical condition regardless of causal relationship to treatment. SAE=untoward medical occurrence that is life-threatening, a congenital anomaly/birth defect, or an important medical event, or results in death, inpatient hospitalization/prolongation of hospitalization, or persistent/significant disability. AE grades: mild (1), moderate (2), severe (3), life-threatening (4), death (5). ALT flare= >2x baseline & >10x ULN up to end of therapy + 5 days. Hepatic SAE=SAEs consistent with worsening of hepatitis or hepatic decompensation.|cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset|As-treated population. 1 participant was randomized to ADV, but treated with ETV was counted in the ETV group.||Participants|||Number
173440|NCT00096785|Secondary|HBV DNA Viral Kinetics - Spline Model|This analysis uses a 3-parameter piece-wise linear model and describes the biphasic decline in HBV DNA (measured by PCR assay) through Week 12. The 3 parameters are the values for the 2 slopes, describing the first and second phase declines, respectively, and the estimated HBV DNA at the knot (at day 10; the time point where the 2 phases join). The biphasic viral decay kinetics for each treatment were obtained using a spline fitting procedure to estimate the 3 parameters for each subject; these estimates were then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||log10 copies/mL|||Number
173441|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. An important derived parameter is the half-life of free virus (ie, the average amount of time for HBV particles in plasma to be reduced to half the initial level), calculated as 24*ln(2)/c. The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||hours|||Number
173442|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the clearance rate of the free virus (c), the death rate of productively infected cells (δ), The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||per day|||Number
173443|NCT00096785|Secondary|HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections|The biphasic decline of HBV DNA is characterized via a 4-parameter exponential decay model previously published for HBV compounds. The model parameters of interest are the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε) and effectiveness of the study treatment in blocking de novo infection of susceptible cells (η). The model parameters reflect the biphasic pattern that is typically observed after initiation of antiviral therapy. Parameters were estimated for each subject separately and then averaged within each treatment group.|Week 12|Treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||percent effective|||Number
173444|NCT00096785|Secondary|Alanine Aminotransferase (ALT) Normalization|Number of participants with ALT ≤ 1 x upper limit of normal (ULN)|Week 48|treated subjects who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||participants|||Number
173445|NCT00096785|Secondary|Viral Load Undetectable (HBV DNA <300 Copies/mL)|Number of Subjects with HBV DNA <300 copies/mL by Roche COBAS® Amplicor (limit of quantitation 300 copies/mL)|Week 48|Treated participants who had both baseline and Week 12 HBV DNA measurements and who received the randomized treatment. 1 participant randomized to ADV actually received ETV and is not counted in secondary efficacy analyses.||Participants|||Number
173473|NCT00096265|Secondary|Cause of Death (Neurologic vs Other)|Compared between two arms using a two-group chi-squared test. Summarized in a 2x2 frequency table.|From randomization to date of death.||||||
173447|NCT00096785|Primary|Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12|Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR (log10 copies/mL) at Week 12, adjusted for baseline (Week 12 - baseline). A negative value = improvement.|Baseline, Week 12|As-randomized participants who completed 12 weeks of treatment||log10 copies/mL||Standard Error|Mean
173448|NCT00096681|Secondary|Number of Participants With a Positive HIV Test|Prevalence of HIV in the community based on a positive oral mucosal transudate sample obtained at the once off study visit.|HIV status at the time of the study visit|||Participants|||Number
173449|NCT00096681|Primary|Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis|Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit.|Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit|||Participants|||Number
173450|NCT00096538|Primary|Tumor Response Rate Every 4 Weeks||2 years|||participants|||Number
173451|NCT00096486|Primary|Overall Objective Response|Determine efficacy of the combination oral daily gefitinib and oral daily RAD001 in patients with advanced NSCLC. Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST).|2 years|||participants|||Number
173452|NCT00096460|Primary|Lymphoma Progression-free Survival||Three years post-Hematopoietic Stem Cell Transplant (HSCT)|||participants|||Number
173453|NCT00096447|Secondary|Prognostic Factors (Initial Performance Status and Histological Grade)||Up to 6 years||||||
173454|NCT00096447|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||Months||95% Confidence Interval|Median
173455|NCT00096447|Secondary|Duration of Progression-free Survival|Conducted against the historical controls using a proportional hazards model that includes histological grade, performance status, and platinum sensitivity.|From study entry until disease recurrence, death, or date of last contact, assessed up to 5 years||||||
173456|NCT00096447|Secondary|Percentage of Patients With Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
173457|NCT00096447|Primary|Frequency and Severity of Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 3.0|The frequency and severity of all toxicities are tabulated.|Up to 5 years||||||
173458|NCT00096447|Primary|Percentage of Patients With Progression-free Survival > 6 Months|Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, for up to 5 years.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
173459|NCT00096382|Primary|Safety|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|4 years|||Participants|||Number
173460|NCT00096382|Primary|Clinical Tumor Regression|Tumor regression is defined as a complete response (CR) or partial response (PR) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|Every 4-6 weeks for up to 1 year, and then every 6 months for up to 5 years.|||Participants|||Number
173461|NCT00096356|Secondary|Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization|CES-D is the Center for Epidemiologic Studies Depression Form. It consists of 20 questions. The total score ranges from 0 to 60. Higher scores indicate greater depression.|24 weeks|||units on a scale||Standard Error|Least Squares Mean
173462|NCT00096356|Secondary|Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization|FACT-B stands for Functional Assessment of Cancer Therapy - Breast. It measures quality of life. It is the total of the FACT subscales (emotional, social, functional, and physical) and the Breast subscale. Scores range from 0 to 144; higher scores reflect better overall quality of life.|24 weeks|||units on a scale||Standard Error|Least Squares Mean
173463|NCT00096356|Primary|Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization|POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.|24 weeks|||units on a scale||Standard Error|Least Squares Mean
173464|NCT00096278|Secondary|Bevacizumab Immunogenicity and Post-treatment Serum Levels of Bevacizumab in Patients Receiving Bevacizumab||Group 2: Pre-therapy, every 2 weeks during chemotherapy/bevacizumab therapy, every 6 weeks during bevacizumab therapy and at 3 and 6 months after completion of bevacizumab therapy||||||
173465|NCT00096278|Secondary|Ovarian Function in Premenopausal Women as Measured by Serum Ovarian Function Test||Group 2: Measured pre-therapy and then every 6 months for 2 years following randomization||||||
173466|NCT00096278|Secondary|Delayed Vascular Events Such as Myocardial Infarction, Central Nervous System (CNS) Ischemia, and Thrombosis in Patients Receiving Chemotherapy + Bevacizumab||Events measured regularly during chemotherapy and bevacizumab therapy||||||
173467|NCT00096278|Secondary|As Measured by Blood Pressure and Antihypertensive Medication Hypertension||Group 2, every 3 months for one year post treatment||||||
173468|NCT00096278|Secondary|The Risk Factors for Development of Proteinuria||For Groups 1 and 2 at the end of every 3 cycles of chemotherapy plus or minus bevacizumab; for Group 2 patients, every 6 weeks for 6 months. If UPC ratio is greater than or equal to 1.0 at the end of therapy then test every 3 months for 12 months||||||
173478|NCT00096265|Secondary|Time to CNS Progression|CNS progression will be defined as any increase in perpendicular bi-dimensional tumor area for any of the 1-3 tracked brain metastases, by any amount, or the appearance of any new brain metastasis on a follow-up MRI (SRS planning scan will not be used to evaluate CNS progression).|From the date of randomization to date of progression, death, or last follow-up. Analysis occurs at the same time as the primary outcome analysis.||||||
173479|NCT00096265|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact.|From randomizaton to date of death for last follow-up. Analysis occurs after all patients have been potentiall followed for 9 months.|All eligible patients.||months||95% Confidence Interval|Median
173480|NCT00096226|Secondary|Toxicity||From start of treatment to end of follow-up||||||
173481|NCT00096226|Secondary|Progression-free Survival||From registration to two years||||||
173482|NCT00096226|Secondary|Overall Survival||From registration to two years||||||
173483|NCT00096226|Secondary|Rates of R0, R1, and R2 Resections After Chemotherapy||At completion of concurrent chemotherapy and radiation therapy||||||
173484|NCT00096226|Secondary|Rate of Resectability After Chemotherapy||At completion of concurrent chemotherapy and radiation therapy||||||
173485|NCT00096226|Secondary|Rate of Major Morbidities Within 30 Days of Surgery||From date of surgery to 30 days following the date of surgery||||||
173486|NCT00096226|Secondary|Rate of Complete Pathological Response After Concurrent Chemotherapy and Radiation Therapy||At completion of concurrent chemotherapy and radiation therapy||||||
173487|NCT00096226|Primary|Mediastinal Nodal Clearance Rate|If at least 12 of the first 21 evaluable patients and at least 27 of the the first 45 evaluable patients have mediastinal nodal clearance (MNC), then a conclusion of a 70% MNC rate (compared to 50%) is made using Simon's two-stage design with 90% power and 10% type I error.|At completion of concurrent chemotherapy and radiation therapy, up to 14 weeks.|Eligible patients who started protocol treatment and had adequate pathologic information of mediastinal nodal status.||participants|||Number
173488|NCT00096200|Secondary|Overall Survival|Overall survival time is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.|2 years||||||
173489|NCT00096200|Secondary|Evaluate the Progression-free Survival Rate|At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|every 2 cycles (6 weeks)||||||
173490|NCT00096200|Primary|Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.|after 6 weeks (2 cycles)|Patients that received 2 cycles of treatment. Includes results from patients that crossed over to Arm C.||participants|||Number
173491|NCT00096174|Secondary|Overall Response Rate|Response was assessed per Response Evaluation in Solid Tumor (RECIST) criteria by physical assessment and CT. Overall response = complete response (CR) + partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions, along with non-progressive disease of non-target lesions. Overall response rate (i.e., proportion of patients who had CR or PR) and the corresponding 90% confidence intervals were calculated for the 60 eligible and treated patients|assessed after all chemoradiation therapy completed Week 9, then every 3 months on C225 maintenance therapy, and every 3 months for 2 years, every 6 months post-treatment 2 years from study entry|Eligible and treated||proportion of participants||90% Confidence Interval|Number
173492|NCT00096174|Secondary|2-year Overall Survival Rate|Overall survival was defined as time from registration to death from any cause. Patients alive at last follow-up were censored. The 2-year overall survival rate was defined as the percentage of patients that were still alive two years after registration into the study. Kaplan-Meier estimate of 2-year overall survival was calculated in the 60 eligible and treated patients.|assessed very 3 months for 2 years|Eligible and treated||proportion of participants||95% Confidence Interval|Number
173493|NCT00096174|Primary|2-year Progression-free Survival Rate|Two-year progression-free survival rate was defined as the proportion of patients that were alive progression-free two years after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 2-year progression-free survival was calculated in the 60 eligible and treated patients.|assessed every 3 months for 2 years|Eligible and treated||proportion of participants||95% Confidence Interval|Number
173494|NCT00096135|Primary|Event-free Survival|Monitoring of efficacy results will be performed in comparison with historical results.|3 years|The CNS-treatment cohort includes 126 patients with 120 CNS pre-B, 2 CNS+ITR pre-B and 4 T-AL. The primary analysis was restricted to CNS pre-B and ITR pre-B patients, respectively. Both CNS+ITR and T-ALL patients had to be excluded from the primary analysis. That is how we came to 120 in the CNS-treatment cohort for outcome analysis.||percentage of participants|||Number
173495|NCT00096122|Primary|Number of Participants With Complete Response|Complete Response (CR) is required bone marrow blasts ≤5% and recovery of normal hematopoiesis with an absolute neutrophil count (ANC) of 1*10^9/L or more and platelet count of 100*10^9/L or more; and a complete response without platelets (CRp) is the same criteria as CR but with platelet counts from 20*10^9/L to less than 100*10^9/L.|21 Day Cycle|Analysis was per protocol.||Participants|||Number
173496|NCT00096109|Primary|Her2/Neu Status|"Response rates will be estimated separately for her2/neu positive and her2/neu negative individuals along with 95% confidence intervals.~PLEASE NOTE: IT WAS PROPOSED TO ANALYZE OUTCOME BY HER2 STATUS, NO DATA WAS COLLECTED OR EVALUATED."|Baseline|No participants were evaluated for her2/neu status.|||||
173497|NCT00096109|Primary|Progression Free Survival (PFS)|PFS is defined as either progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.|Up to 7 years|||months||95% Confidence Interval|Median
173498|NCT00096109|Primary|Response Rate (Complete Response (CR) +Partial Response (PR)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 7 years|||Participants|||Count of Participants
173499|NCT00096031|Secondary|Time to Progression||every 3 weeks while on treatment, then every 3 months for 3 years|||months||95% Confidence Interval|Median
173500|NCT00096031|Secondary|Time to Treatment Failure||every 3 weeks while on treatment|||months||95% Confidence Interval|Median
173501|NCT00096031|Primary|Overall Survival at 6 Months||every 3 weeks while on treatment, then every 3 months|||percentage of participants||95% Confidence Interval|Number
173502|NCT00096018|Primary|Duration of Response||4 weeks, every 3 months for 2 years, and then every 4 months for 2 years|Patients with Complete or Partial Response||months||Standard Deviation|Mean
173503|NCT00096018|Primary|Overall Responders (Complete and Partial Response)|Criteria for response were based on the Revised National Cancer Institute-sponsored Working Group Guidelines for response, which includes clinical, hematologic, and bone marrow features (Cheson, B.D., et al., National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-97.)|4 weeks, every 3 months for 2 years, and then every 4 months for 2 years|All Treated Patients||participants|||Number
173504|NCT00095979|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated patients||months||95% Confidence Interval|Median
173505|NCT00095979|Secondary|Progression-free Survival|Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first.|From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.|Eligible and Treated Patients||months||95% Confidence Interval|Median
173506|NCT00095979|Primary|Frequency and Severity of Observed Adverse Effects||Every cycle until completion of study treatment up to 30 days after stopping study treatment||||||
173507|NCT00095979|Primary|Tumor Response|Complete and Partial Tumor Response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST)|Every other cycle for first 6 months; then every six months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
173508|NCT00095940|Secondary|Number of Participants With Tumors Expressing Phosphorylated ERBB2 (Phase II Objective)|Phosphorylated ERBB2 expression is assessed in patients who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of phosphorylated ERBB2. Low, moderate, and intense expression are combined into one group vs. no phosphorylated ERBB2 expression.|Pre-treatment|Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population.||Participants|||Number
173509|NCT00095940|Secondary|Number of Participants With Tumors Expressing Total ERBB2|Total ERBB2 expression is assessed in participants enrolled in both the molecular biology trial and the phase II trial who provided pre-treatment formalin fixed paraffin embedded tumor material. The tumor material is analyzed by immunohistochemistry for expression of total ERBB2. Low, moderate, and intense expression are combined into one group vs. no total ERBB2 expression.|Pre-treatment|Participants from the molecular biology trial or the phase II trial who consented to the biology studies and provided pre-treatment formalin fixed paraffin embedded tumor were included in the analysis population.||Participants|||Number
173510|NCT00095940|Secondary|Maximum Concentration of Lapatinib in Plasma (Phase II Objective)|Serial plasma samples for pharmacokinetic studies of lapatinib will be collected from consenting participants with the first dose of course 1.|First dose of lapatinib in course 1|The analysis population consists of participants with recurrent medulloblastoma, high grade glioma, or ependymoma who did not have surgical resection of the tumor at study enrollment, consented to the pharmacokinetic studies, and received the first dose of lapatinib in course 1.||nanogram/milliliter||Full Range|Median
173511|NCT00095940|Secondary|Tumor to Plasma Lapatinib Concentration (Molecular Biology Objective)|For participants randomized to receive lapatinib 7-14 days prior to surgery, plasma samples will be obtained with the first dose of lapatinib prior to surgery. The lapatinib concentration is measured in both the plasma samples and the tumor tissue obtained at surgery. Reported is the concentration of lapatinib observed in the tumor expressed as a percentage of the concentration observed in plasma.|First dose of lapatinib prior to surgery|The analysis population consists of recurrent medulloblastoma, high grade glioma, or ependymoma patients who were randomized to receive lapatinib prior to surgery, consented to the pharmacokinetic studies and received dose 1 of lapatinib.||percent||Full Range|Median
173512|NCT00095940|Primary|Number of Participants With a Sustained Objective Response (Complete or Partial Response) (Phase II Objective)|A complete response is defined as complete disappearance of all tumor accompanied by a stable or improving neurologic exam, and a partial response is defined as 50% or more reduction in the tumor size by bi-dimensional measurement and a stable or improving neurologic exam. The response must be sustained for at least 8 weeks. The number of patients with a sustained objective response will be reported separately for each of the three disease groups.|From start of therapy until the earliest of disease progression, death or end of the fourth course (recurrent medulloblastoma and recurrent high grade glioma) or end of the sixth course (recurrent ependymoma)|Participants with measureable residual disease who do not receive lapatinib prior to surgery or who do not have surgical resection of the tumor at study enrollment will be assessed for sustained objective response. Participants must have received at least one dose of lapatinib and remain on treatment for the specified time frame to be evaluable.||Participants|||Number
173529|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 5|Six patients had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
173513|NCT00095940|Primary|Relative Phosphorylation of ERBB2 (Molecular Biology Objective)|Lapatinib may be able to control the growth of tumor cells. To assess the ability of lapatinib to block a molecule, the ERBB2 receptor, that signals tumor cells to divide, fresh frozen tissue from the surgical resection is processed by quantitative western blot analysis to assess the phosphorylation of ERBB2. The relative phosphorylation is a ratio of the phosphorylated ERBB2 measured in the tumor normalized to the level of total receptor protein and housekeeping protein. Lower values suggests more inhibition of the ERRB2 receptor signal and a decreased ability for tumor cell division.|7-14 days after starting therapy and prior to surgery|Participants enrolled on the molecular biology phase (MBP) and who submitted fresh frozen tissue were included in the analysis for this objective. One patient enrolled on the MBP did not provide fresh frozen tissue and was excluded. The sample size required for this objective was not met.||ratio||Full Range|Median
173514|NCT00095875|Secondary|Progression-free Survival and Disease-specific Survival as Assessed by Disease Progression or Death and Log Rank Tests at the Median, and 2, 3, and 5 Years|Progression free survival was defined as the time from date of randomisation to disease progression or death from any cause without progression whichever occurred first; otherwise, patients were censored at the date last known to be free of progression.|5 years|||percent of patients||95% Confidence Interval|Number
173515|NCT00095875|Primary|Overall Survival|To compare the 3-year survival achieved by docetaxel/cisplatin/5-FU based sequential therapy with platinum based chemo radiotherapy in patients with locally advanced SCCHN. Overall survival is defined as the time from date of randomisation to death from any cause. Patients alive at the time of current analysis were censored at the date last known to be alive.Kaplan-Meier method was used to estimate overall survival|3-years|||percent of patients||95% Confidence Interval|Number
173516|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 12|Seven patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
173517|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 5|Seven patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
173518|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 2, Day 1|Nine patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
173519|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 12|Three patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
173520|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 5|Three patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
173521|NCT00095784|Secondary|Hemoglobin F|"Percentage of hemoglobin F as a proportion of total Hb (%HbF) measured by HPLC on peripheral blood samples.~Midpoint of 0.5% imputed for values reported as below limit of detection (1.0%). Hemoglobin F has been previously shown to be upregulated by decitabine in other hematologic disorders- sickle cell disease specifically. The rationale for exploring it in this study was to evaluate its potential utility as a biomarker of drug effect/PD marker."|Cycle 1, Day 1|Four patients had missing data.||percentage of HbF||95% Confidence Interval|Mean
173522|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 12|Eleven patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
173523|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 5|Seven patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
173524|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 2, Day 1|Seven patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
173525|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 12|Three patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
173526|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 5|Three patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
173527|NCT00095784|Secondary|CXCR4|CXCR4 gene expression level measured by real-time RT_PCR. Ratio of CXCR4 vs a housekeeping gene (i.e., ABL)|Cycle 1, Day 1|Four patients had missing data.||ratio||95% Confidence Interval|Geometric Mean
173528|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 12|Six patients had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
173530|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 2, Day 1|Five patients had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
173531|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 12|Three patients had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
173532|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 5|One patient had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
173533|NCT00095784|Secondary|CD34+ Cells|CD34 positive(+) cells are determined by flow immunostaining and light scatter in peripheral blood. Samples are then analyzed by flow cytometry, and CD34+ cells quantitated after 75,000 CD45 events are studied. (At least 75,000 CD45 events must be studied to ensure accuracy of the assay). Absolute numbers are determined by multiplying the % CD34+ cells by the total white blood cell count obtained on a CBC that is processed simultaneously.|Cycle 1, Day 1|One patient had missing data.||cells x 10^6/L||95% Confidence Interval|Geometric Mean
173534|NCT00095784|Primary|Incidence of Toxicities, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0|Percentage of patients experiencing any toxicity, any grade level. Additional details on adverse events are reported in Adverse Events section.|Up to 30 days of last dose of decitabine|||percentage of patients||95% Confidence Interval|Number
173535|NCT00095784|Primary|Response Rate (Complete Response, Partial Response, or Hematologic Improvement.|"Complete response is normalization of counts and transfusion-independence.~Partial response is hemoglobin increase to normal levels, multilineage improvement including absolute neutrophil count (ANC) and/or platelets.~Hematologic improvement is red cell transfusion-independence or >50% increase in platelet levels."|Up to 36 weeks (6 cycles)|Two patients were non-evaluable for response.||percentage of participants||90% Confidence Interval|Number
173536|NCT00095576|Primary|HIV-1 Viral Load in Infected Participants|Plasma HIV-1 viral RNA was to be measured using a ribonucleic acid polymerase chain reaction (RNA PCR) on the last archived sample, and at Weeks 1, 2, 8, 12, and 26 post-HIV-1 infection, and subsequently every 6 months.|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)|An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.|||||
173537|NCT00095576|Primary|Number of Participants With HIV-1 Infections|The number of participants with HIV-1 infections was to be determined with a periodic HIV-1 screening test to detect antibodies to recombinant HIV-1 envelope protein in the participants' serum.|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)|An interim analysis for this study showed that the MRK Ad5 HIV-1 gag/pol/nef vaccine used in this study was not efficacious; therefore, this outcome measure was not analyzed and only a high level summary of the safety data was performed.|||||
173538|NCT00095576|Primary|Number of Participants With Laboratory Adverse Experiences|"Number of participants with laboratory adverse experiences with an incidence cut-off of 5% (events occurring > 5% in at least one treatment group) following administration of the first dose of study vaccine.~Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body.~All laboratory AEs were collected up to 14 days after any vaccine dose."|Day 1 to Week 208|||Participants|||Number
173539|NCT00095576|Primary|Number of Participants With Clinical Adverse Experiences|"Number of participants with non-serious AEs with an incidence cut-off of 5% (>5% in at least one treatment group) and number of participants with >1 SAE following administration of study vaccine.~AEs collected include serious and non-serious systemic AEs, and injection-site AEs. All systemic AEs were collected up to 14 days after any vaccine dose, and serious AEs were collected for the entire study period (up to Week 210).~Injection-site AEs are any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to Day 4 after any vaccine dose."|Day 1 to End of Study (Week 210 for HIV uninfected participants and Week 338 for HIV infected participants)|||Participants|||Number
173540|NCT00095498|Secondary|Number of Participants With Laboratory Common Terminology Criteria for Adverse Events (CTCAE) Grade Greater or Equal to 3|"Participants with laboratory toxicity of grade 3 or 4, graded according to the Common Terminology Criteria for Adverse Events, version 3.0, on the following general guideline:~Grade 1 - Mild AE; Grade 2 - Moderate AE; Grade 3 - Severe AE; Grade 4 - Life-threatening or disabling AE; Grade 5 - Death related to AE."|Month 1, month 3, month 6, month 12|Patients who received at least 1 dose of investigational product.||Participants|||Number
173541|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 12|Laboratory hematology white blood cells|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
173542|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 6|Laboratory hematology white blood cells|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
173543|NCT00095498|Secondary|Change From Baseline in White Blood Cells at Month 3|Laboratpry hematology white blood cells|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
173555|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 3|Laboratory hematology total neutrophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
173556|NCT00095498|Secondary|Change From Baseline in Total Neutrophils at Month 1|Laboratory hematology total neutrophils|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
173557|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 12|Laboratory hematology monocytes|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
173558|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 6|Laboratory hematology monocytes|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
173559|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 3|Laboratory hematology monocytes|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
173560|NCT00095498|Secondary|Change From Baseline in Monocytes at Month 1|Laboratory hematology monocytes|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
173561|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 12|Laboratory hematology lymphocytes|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
173562|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 6|Laboratory hematology lymphocytes|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
173563|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 3|Laboratory hematology lymphocytes|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
173564|NCT00095498|Secondary|Change From Baseline in Lymphocytes at Month 1|Laboratory hematology lymphocytes|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
173565|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 12|Laboratory hematology hemoglobin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||g/L||Standard Deviation|Mean
173566|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 6|Laboratory hematology hemoglobin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||g/L||Standard Deviation|Mean
173567|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 3|Laboratory hematology hemoglobin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||g/L||Standard Deviation|Mean
173568|NCT00095498|Secondary|Change From Baseline in Hemoglobin at Month 1|Laboratory hematology hemoglobin|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||g/L||Standard Deviation|Mean
173569|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 12|Laboratory hematology hematocrit|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||Proportion of red blood cells in blood||Standard Deviation|Mean
173570|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 6|Laboratory hematology hematocrit|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||Proportion of red blood cells in blood||Standard Deviation|Mean
173571|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 3|Laboratory hematology hematocrit|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||Proportion of red blood cells in blood||Standard Deviation|Mean
173572|NCT00095498|Secondary|Change From Baseline in Hematocrit at Month 1|Laboratory hematology hematocrit|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||Proportion of red blood cells in blood||Standard Deviation|Mean
173573|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 12|Laboratory hematology eosinophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
173574|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 6|Laboratory hematology eosinophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
173575|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 3|Laboratory hematology eosinophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
173576|NCT00095498|Secondary|Change From Baseline in Eosinophils at Month 1|Laboratory hematology eosinophils|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||* 10^9/L||Standard Deviation|Mean
173577|NCT00095498|Secondary|Change From Baseline in Basophils at Month 12|Laboratory hematology basophils|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||* 10^9/L||Standard Deviation|Mean
173578|NCT00095498|Secondary|Change From Baseline in Basophils at Month 6|Laboratory hematology basophils|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||* 10^9/L||Standard Deviation|Mean
173579|NCT00095498|Secondary|Change From Baseline in Basophils at Month 3|Laboratory hematology basophils|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||* 10^9/L||Standard Deviation|Mean
173580|NCT00095498|Secondary|Change From Baseline in Basophils at Month 1|Laboratory hematology basophils|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||*10^9/L||Standard Deviation|Mean
173581|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 12|Laboratory chemistry alanine amino transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||U/L||Standard Deviation|Mean
173582|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 6|Laboratory chemistry alanine amino transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||U/L||Standard Deviation|Mean
173583|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 3|Laboratory Chemistry alanine amino transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||U/L||Standard Deviation|Mean
173584|NCT00095498|Secondary|Change From Baseline in Alanine Amino Transferase at Month 1|Laboratory chemistry alanine amino transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||U/L||Standard Deviation|Mean
173585|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 12|Laboratory chemistry aspartate amino transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||U/L||Standard Deviation|Mean
173586|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase|Laboratory chemistry aspartate amino transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||U/L||Standard Deviation|Mean
173587|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 3|Laboratory chemistry aspartate amino transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||U/L||Standard Deviation|Mean
173588|NCT00095498|Secondary|Change From Baseline in Aspartate Amino Transferase at Month 1|Laboratory chemistry aspartate amino transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||U/L||Standard Deviation|Mean
173589|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 12|Laboratory chemistry total protein|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||g/L||Standard Deviation|Mean
173590|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 6|Laboratory chemistry total protein|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||g/L||Standard Deviation|Mean
173591|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 3|Laboratory chemistry total protein|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||g/L||Standard Deviation|Mean
173592|NCT00095498|Secondary|Change From Baseline in Total Protein at Month 1|Laboratory chemistry total protein|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||g/L||Standard Deviation|Mean
173593|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 12|Change From Baseline in Phosphorus at Month 12|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
173594|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 6|Laboratory chemistry phosphorus|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
173595|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 3|Laboratory chemistry phosphorus|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
173596|NCT00095498|Secondary|Change From Baseline in Phosphorus at Month 1|Laboratory chemistry phosphorus|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
173597|NCT00095498|Secondary|Change From Baseline in Sodium at Month 12|Laboratory chemistry sodium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
173598|NCT00095498|Secondary|Change From Baseline in Sodium at Month 6|Laboratory chemistry sodium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
173599|NCT00095498|Secondary|Change From Baseline in Sodium at Month 3|Change From Baseline in Sodium at Month 3|Baseline, Month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
173600|NCT00095498|Secondary|Change From Baseline in Sodium at Month 1|Laboratory chemistry sodium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
173601|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 12|Laboratory chemistry magnesium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
173602|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 6|Laboratory chemistry magnesium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
173603|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 3|Laboratory chemistry magnesium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
173604|NCT00095498|Secondary|Change From Baseline in Magnesium at Month 1|Laboratory chemistry magnesium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
173605|NCT00095498|Secondary|Change From Baseline in Potassium at Month 12|Laboratory chemistry potassium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
173606|NCT00095498|Secondary|Change From Baseline in Potassium at Month 6|Laboratory chemistry potassium|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
173607|NCT00095498|Secondary|Change From Baseline in Potassium at Month 3|Laboratory chemistry potassium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
173608|NCT00095498|Secondary|Change From Baseline in Potassium at Month 1|Laboratory chemistry potassium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
173609|NCT00095498|Secondary|Change From Baseline in Glucose at Month 12|Laboratory chemistry glucose|baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
173610|NCT00095498|Secondary|Change From Baseline in Glucose at Month 6|Laboratory chemistry glucose|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
173611|NCT00095498|Secondary|Change From Baseline in Glucose at Month 3|Laboratory chemistry glucose|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
173612|NCT00095498|Secondary|Change From Baseline in Glucose at Month 1|Laboratory chemistry glucose|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
173613|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 12|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||U/L||Standard Deviation|Mean
173614|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 6|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||U/L||Standard Deviation|Mean
173615|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 3|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||U/L||Standard Deviation|Mean
173616|NCT00095498|Secondary|Change From Baseline in Gamma-Glutamyl Transferase at Month 1|Laboratory chemistry gamma-glutamyl transferase|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||U/L||Standard Deviation|Mean
173617|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 12|Laboratory chemistry creatinine|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||µmol/L||Standard Deviation|Mean
173618|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 6|Laboratory chemistry creatinine|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||µmol/L||Standard Deviation|Mean
173619|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 3|Laboratory chemistry creatinine|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||µmol/L||Standard Deviation|Mean
173620|NCT00095498|Secondary|Change From Baseline in Creatinine at Month 1|Laboratory chemistry creatinine|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||µmol/L||Standard Deviation|Mean
173621|NCT00095498|Secondary|Change From Baseline in Chloride at Month 12|Laboratory chemistry chloride|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
173622|NCT00095498|Secondary|Change From Baseline in Chloride at Month 6|Laboratory chemistry chloride|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
173623|NCT00095498|Secondary|Change From Baseline in Chloride at Month 3|Laboratory chemistry chloride|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
173624|NCT00095498|Secondary|Change From Baseline in Chloride at Month 1|Laboratory chemistry chloride|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
173625|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 12|Laboratory chemistry albumin-adjusted calcium|Baselien, Month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
173626|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 6|Laboratory chemistry albumin-adjusted calcium|Baseline, Month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
173627|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 3|Laboratory chemistry albumin-adjusted calcium|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
173628|NCT00095498|Secondary|Change From Baseline in Calcium (Corrected) at Month 1|Laboratory chemistry albumin-adjusted calcium|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
173629|NCT00095498|Secondary|Change From Baseline in Calcium at Month 12|Laboratory chemistry calcium|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
173630|NCT00095498|Secondary|Change From Baseline in Calcium at Month 6|Laboratory chemistry calcium|baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
173631|NCT00095498|Secondary|Change From Baseline in Calcium at Month 3|Laboratory chemistry calcium|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
173632|NCT00095498|Secondary|Change From Baseline in Calcium at Month 1|Laboratory chemistry calcium|baseline. month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
173633|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 12|Laboratory chemistry blood urea nitrogen|baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
173634|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 6|Laboratory chemistry blood urea nitrogen|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
173635|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 3|Laboratory chemistry blood urea nitrogen|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
173636|NCT00095498|Secondary|Change From Baseline in Blood Urea Nitrogen at Month 1|Laboratory chemistry blood urea nitrogen|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
173637|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 12|Laboratory chemistry total bilirubin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||umol/L||Standard Deviation|Mean
173638|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 6|Laboratory chemistry total bilirubin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||umol/L||Standard Deviation|Mean
173639|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 3|Laboratory chemistry total bilirubin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||umol/L||Standard Deviation|Mean
173640|NCT00095498|Secondary|Change From Baseline in Total Bilirubin at Month 1|Laboratory chemistry total bilirubin|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||umol/L||Standard Deviation|Mean
173641|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 12|Laboratory chemistry bicarbonate|Baseline, Month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||mmol/L||Standard Deviation|Mean
173642|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 6|Laboratory chemistry bicarbonate|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||mmol/L||Standard Deviation|Mean
173643|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 3|Laboratory chemistry bicarbonate|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||mmol/L||Standard Deviation|Mean
173644|NCT00095498|Secondary|Change From Baseline in Bicarbonate at Month 1|Laboratory chemistry bicarbonate|baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||mmol/L||Standard Deviation|Mean
173645|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 12|Laboratory chemistry alkaline phosphatase|baseine, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||U/L||Standard Deviation|Mean
173646|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 6|Laboratory chemistry alkaline phosphatase|baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||U/L||Standard Deviation|Mean
173647|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 3|Laboratory chemisrty alkaline phosphatase|baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||U/L||Standard Deviation|Mean
173648|NCT00095498|Secondary|Change From Baseline in Alkaline Phosphatase at Month 1|Laboratory chemistry alkaline phoshatatse|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||U/L||Standard Deviation|Mean
173649|NCT00095498|Secondary|Change From Baseline in Albumin at Month 12|Laboratory chemistry albumin|Baseline, month 12|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 12.||g/L||Standard Deviation|Mean
173650|NCT00095498|Secondary|Change From Baseline in Albumin at Month 6|Laboratory chemistry albumin|Baseline, month 6|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 6.||g/L||Standard Deviation|Mean
173651|NCT00095498|Secondary|Change From Baseline in Albumin at Month 3|Laboratory chemistry albumin|Baseline, month 3|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 3.||g/L||Standard Deviation|Mean
173652|NCT00095498|Secondary|Change From Baseline in Albumin at Month 1|Laboratory Chemistry Albumin|Baseline, month 1|Subjects who received at least 1 dose of investigational product who had nonmissing data at baseline and month 1.||g/L||Standard Deviation|Mean
173653|NCT00095498|Secondary|Number of Participants With Anti-Denosumab Binding Antibody and Neutralizing Antibody|Serum from participants testing positive for anti-denosumab binding antibodies was tested in a cell-based bioassay for neutralizing activity against denosumab.|Baseline to Month 12|Patients who were positive for anti-denosumab antibodies||Participants|||Number
173654|NCT00095498|Secondary|Number of Participants With Anti-Denosumab Binding Antibodies|Serum from participants was tested for antibodies to denosumab by immuoassay at months 1, 3, 6 and 12. The number of participants with anti-denosumab antibodies at any assessment is reported.|Assessed at Baseline and at Months 1, 3, 6 and 12.|Patients who received at least 1 dose of investigational product and with at least one postbaseline sample taken.||Participants|||Number
173655|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 12|Percent change from baseline to Month 12 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Inter-Quartile Range|Median
173853|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)||ADV Week 240|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
173656|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II C-Tx /Creatinine at Month 6|Percent change from baseline to Month 6 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Inter-Quartile Range|Median
173657|NCT00095498|Secondary|Percent Change From Baseline in Urine Type II Collagen C-telopeptide (C-Tx) /Creatinine at Month 3|Percent change from baseline to Month 3 in urine Type II collagen C-Telopeptide (CTX)/Creatinine calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.||Percent change from baseline||Inter-Quartile Range|Median
173658|NCT00095498|Secondary|Percent Change From Baseline in P1NP at Month 12|Percent change from baseline to Month 12 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Inter-Quartile Range|Median
173659|NCT00095498|Secondary|Percent Change From Baseline in P1NP at Month 6|Percent change from baseline to Month 6 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Inter-Quartile Range|Median
173660|NCT00095498|Secondary|Percent Change From Baseline in Procollagen 1 N-terminal Peptide (P1NP) at Month 3|Percent change from baseline to Month 3 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.||Percent change from baseline||Inter-Quartile Range|Median
173661|NCT00095498|Secondary|Percent Change From Baseline in Serum CTX at Month 12|Percent change from Baseline to Month 12 in serum C-Telopeptide (CTX) Type I calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Inter-Quartile Range|Median
173662|NCT00095498|Secondary|Percent Change From Baseline in Serum CTX at Month 6|Percent change from baseline to Month 6 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 6 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Inter-Quartile Range|Median
173663|NCT00095498|Secondary|Percent Change From Baseline in Serum Collagen C-Telopeptide (CTX) at Month 3|Percent change from baseline to Month 3 in serum Collagen C-Telopeptide (CTX) Type I calculated using ((Month 3 value - Baseline value) / Baseline value ) x 100.|Baseline, Month 3|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 3 months.||Percent change from baseline||Inter-Quartile Range|Median
173664|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Standard Error|Least Squares Mean
173665|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Standard Error|Least Squares Mean
173666|NCT00095498|Secondary|Percent Change From Baseline in Total Hip Bone Mineral Density at Month 1|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.||Percent change from baseline||Standard Error|Least Squares Mean
173667|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Standard Error|Least Squares Mean
173892|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 12 months|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||x 10^3 cells/microliter||Standard Error|Mean
173668|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 6 calculated using ((Month 6 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Standard Error|Least Squares Mean
173669|NCT00095498|Secondary|Percent Change From Baseline in Femoral Neck Bone Mineral Density at Month 1|"Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((Month 1 value - baseline value) / baseline value ) x 100.~Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic)."|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.||Percent change from baseline||Standard Error|Least Squares Mean
173670|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 12 calculated using ((Month 12 value - baseline value) / baseline value ) x 100. Least squares means based on repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||Percent change from baseline||Standard Error|Least Squares Mean
173671|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to month 6 calculated using ((month 6 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||Percent change from baseline||Standard Error|Least Squares Mean
173672|NCT00095498|Secondary|Percent Change From Baseline in Lumbar Spine Bone Mineral Density at Month 1|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from baseline to Month 1 calculated using ((month 1 value - baseline value) / baseline value ) x 100. Least squares means are based on a repeated measures model adjusting for treatment, visit, baseline value, and strata (4 strata from the combination of baseline use of steroid and previous use of biologic).|Baseline, Month 1|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 1 month.||Percent change from baseline||Standard Error|Least Squares Mean
173673|NCT00095498|Secondary|Change From Baseline in Radiographic Joint Space Narrowing Score at Month 6|Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||units on a scale||Inter-Quartile Range|Median
173674|NCT00095498|Secondary|Change From Baseline in Radiographic Joint Space Narrowing Score at Month 12|Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet obtained from radiographs of the hands and feet and assessed by 2 independent readers. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score (indicating worst joint space narrowing) of 168.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||units on a scale||Inter-Quartile Range|Median
173675|NCT00095498|Secondary|Change From Baseline in Radiographic Erosion Score at Month 6|The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||units on a scale||Inter-Quartile Range|Median
173676|NCT00095498|Secondary|Change From Baseline in Radiographic Erosion Score at Month 12|The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet, obtained from radiographs of the hands and feet and assessed by 2 independent readers. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280.|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||units on a scale||Inter-Quartile Range|Median
173893|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 6 months|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||x 10^3 cells/microliter||Standard Error|Mean
173677|NCT00095498|Secondary|Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 6|TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||units on a scale||Inter-Quartile Range|Median
173678|NCT00095498|Secondary|Change From Baseline in Radiographic Total Modified Sharp Score (TSS) at Month 12|TSS is the sum of erosion and joint space narrowing scores obtained from radiographs of the hands and feet, assessed by 2 independent readers. The joint erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints in the feet. Each joint was scored, according to the surface area involved, from 0 (no erosion) to 5 (extensive loss of bone from more than one half of the articulating bone). Because each side of a foot joint was graded on this scale, the maximum erosion score for a foot joint was 10 and the maximal erosion score was 280. Joint Space Narrowing (JSN) Score summarizes the severity of JSN in 30 joints of the hands and 12 joints of the feet. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, was scored from 0 (normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation), with a maximum JSN score of 168. The TSS ranged from 0 (normal) to 448 (worst).|Baseline, Month 12|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 12 months.||units on a scale||Inter-Quartile Range|Median
173679|NCT00095498|Primary|Change From Baseline in Rheumatoid Arthritis Erosion Score Measured From MRI Assessments (RA-MRI ES) at Month 6|Fifteen sites in each wrist and 10 sites in each hand were assessed by a blinded and independent reader. Each site was scored from 0 to 10 (in accordance with the European League Against Rheumatism [EULAR]-Outcome Measures in Rheumatology Clinical Trials convention), with each unit increment representing 10% incremental loss of the peripheral 1 cm of articular bone. The Erosion Score is a sum of erosion scores from 50 joint sites in both hands/wrists and ranges from 0 (normal, no erosion) to 500 (worst possible erosion).|Baseline, Month 6|All randomized patients who received at least 1 dose of investigational product with a non-missing baseline and at least 1 non-missing postbaseline measurement, and with available data at 6 months.||units on a scale||Full Range|Median
173680|NCT00095303|Secondary|Follow Up Study, Risky Sexual Behaviors|For the Follow Up Study, sexual risk behavior was measured by examining the number of unprotected sexual acts and the number of partners and number of sex acts that included substance use the in the 90 day period that preceded the assessment; a latent factor using structural equation modeling will be used created from the Behavioral Risk Assessment. Scores ranged from -0.5 to 11.7. The higher the score, the more risky sexual behavior.|90 days prior assessment|||units on a scale||Standard Error|Least Squares Mean
173681|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 12 Months Post Randomization|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 6.7. The higher the score, the more risky sexual behavior.|12 months post randomization|||units on a scale||Standard Error|Least Squares Mean
173682|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 8 Months Post Randomization|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 6.8. The higher the score, the more risky sexual behavior.|8 months post randomization|||units on a scale||Standard Error|Least Squares Mean
173683|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at 4 Months Post Randomization|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 10.4. The higher the score, the more risky sexual behavior.|4 months post randomization|||units on a scale||Standard Error|Least Squares Mean
173684|NCT00095303|Secondary|Main Study, Risky Sexual Behaviors at Baseline|For the Main Study, the total score of the ‘HIV/Sex Risk Behaviors’ measure was used as the outcome. Scores ranged from -0.5 to 8.7. The higher the score, the more risky sexual behavior.|Baseline|||units on a scale||Standard Error|Least Squares Mean
173685|NCT00095303|Secondary|Follow Up Study, Level of Family Functioning|For the follow up study, family functioning was measured by a composite of the Cohesion and Conflict scales of the Family Environment Scale. Scores ranged from 1.0 to 18.0. The higher the value, the better the level of family functioning outcome.|90 days prior assessment|||units on a scale||Standard Deviation|Mean
173686|NCT00095303|Secondary|Main Study, Level of Family Functioning at 12 Months Post Randomization|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.6 to 2.0. The higher the score, the better outcome of family functioning.|12 months post randomization|||units on a scale||Standard Deviation|Mean
173687|NCT00095303|Secondary|Main Study, Level of Family Functioning at 8 Months Post Randomization|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline.Scores ranged from -2.8 to 2.0. The higher the score, the better outcome of family functioning.|8 months post randomization|||units on a scale||Standard Deviation|Mean
173894|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 3 months|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||x 10^3 cells/microliter||Standard Error|Mean
173688|NCT00095303|Secondary|Main Study, Level of Family Functioning at 4 Months Post Randomization|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -2.9 to 1.8. The higher the score, the better outcome of family functioning.|4 months post randomization|||units on a scale||Standard Deviation|Mean
173689|NCT00095303|Secondary|Main Study, Level of Family Functioning at Baseline|The four components of the ‘Parenting Practices Inventory’ used to create a composite for use in this analysis. The four component scales from the Parenting Practices Inventory are ‘Positive Parenting’, ‘Discipline Effectiveness,’ ‘Avoidance of Discipline’ and ‘Monitoring’ scales from the Pittsburgh Youth Survey. the family functioning composite was standardized by the full sample standard deviation at baseline. Scores ranged from -3.0 to 1.8. The higher the score, the better outcome of family functioning.|Baseline|||units on a scale||Standard Error|Mean
173690|NCT00095303|Secondary|Follow Up Study, Externalizing Behavior|For the follow up study, externalizing behavior for the 90 days prior to the follow up was assessed using the externalizing composite of the Adult Self Report (ASR). The ASR is a 123 item self report scale designed for 18 to 59 year-old to describe their own functioning. Items are on a 3 point likert type scale (0= not true, 1=somewhat true, 2=very true or often true). The externalizing scale is comprised by the aggressive, rule braking and intrusive syndromes. The problem syndromes have been normed by sex and age (18 to 35, or 36 to 59), using a nationally representative sample. Scores were square-root transformed to more closely approximate a normal distribution. Scores ranged from 0 to 7.2. The higher the score, the more externalizing behavior. Participants were also asked to self report arrests in the past year . Externalizing was analyzed using regression|90 days prior to assessment|||units on a scale||Standard Deviation|Mean
173691|NCT00095303|Primary|Follow Up Study, Drug Use|Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.|Number of self reported drug use days 90 days prior to assessment|||days of drug use 90 days prior assessmen||Inter-Quartile Range|Median
173692|NCT00095303|Primary|Follow Up Study, Drug Use|Timeline Follow Back (TLFB) measured drug use. For the Follow Up Study, the TLFB was used to identify drug use in the 90 day period that preceded the assessment. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use over the past 90 days. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use.The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 90 days.|Number of self reported drug use days 90 days prior assessment|||days of drug use 90 days prior assessmen||Inter-Quartile Range|Median
173693|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 337-364|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 337-364. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 337-364||Inter-Quartile Range|Median
173694|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 309-336|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 309-336. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 309-336||Inter-Quartile Range|Median
173712|NCT00095238|Secondary|Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66|Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.|Baseline, Month 42, Month 54, Month 66|Participants with baseline score and score at timepoint.||mL/min/1.73m2||Standard Error|Mean
173695|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use from days 281-308|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 281-308. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 281-308||Inter-Quartile Range|Median
173696|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 253-280|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 253-280. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 253-280||Inter-Quartile Range|Median
173697|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 225-252|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 225-252. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 225-252||Inter-Quartile Range|Median
173698|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 197-224|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 197-224. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 197-224||Inter-Quartile Range|Median
173699|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 169-196|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 169-196. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 169-196||Inter-Quartile Range|Median
173713|NCT00095238|Secondary|Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30|Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.|Baseline, Month 6, Month 18, Month 30|Participants with baseline score and score at timepoint.||mL/min/1.73m2||Standard Error|Mean
173700|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 141 - 168|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 141-168. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 141-168||Inter-Quartile Range|Median
173701|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 113-140|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 113-140. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from days 113-140||Inter-Quartile Range|Median
173702|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 85-112|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 85-112. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 85-112||Inter-Quartile Range|Median
173703|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 57-84|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 57-84. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 57-84||Inter-Quartile Range|Median
173704|NCT00095303|Secondary|Main Study, Externalizing Behavior at 12 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.4. The higher the score, the more externalizing behavior.|12 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 12 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||units on a scale||Standard Deviation|Mean
173705|NCT00095303|Secondary|Main Study, Externalizing Behavior at 8 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.5. The higher the score, the more externalizing behavior.|8 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 8 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||units on a scale||Standard Deviation|Mean
173706|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days in days 29-56|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 29-56. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use in days 29-56||Inter-Quartile Range|Median
173707|NCT00095303|Secondary|Main Study, Externalizing Behavior at 4 Months Post Randomization|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.8. The higher the score, the more externalizing behavior.|4 months post randomization|The number of participants analyzed represents the number of participants that completed this time point, assessing for externalizing behavior at 4 months post randomization. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||units on a scale||Standard Deviation|Mean
173708|NCT00095303|Secondary|Main Study, Externalizing Behaviors at Baseline|For the Main study, an equally weighted composite of the following standardized scales was used to assess externalizing behaviors: ‘Total Delinquency’ from the National Youth Survey; ‘Oppositional Defiant Disorder’ and ‘Conduct Problems’ from the Diagnostic Interview Schedule for Children-Predictive Scales, ‘Externalizing Scale’ from the Youth Self-Report. This composite was then transformed to a z-score using the mean and standard deviation of the baseline in the entire sample. Adolescent externalizing behaviors were assessed at 4-, 8-, and 12-months post randomization.This hypothesis analyzed using hierarchical linear models. Scores ranged from -1.6 to 3.0. The higher the score, the more externalizing behavior.|Baseline|The number of participants analyzed represents the number of participants that completed this time point, assessing externalizing behaviors at baseline. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||units on a scale||Standard Deviation|Mean
173709|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from day 1-28|The number of participants analyzed represents the number of participants that completed this time point, assessing for drug use from day 1-28. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use from day 1-28||Inter-Quartile Range|Median
173710|NCT00095303|Primary|Main Study, Adolescent Drug Use|Timeline Follow Back (TLFB) measured drug use. At baseline, TLFB identified drug use in the 28-day period that preceded the baseline assessment. At all other time points the TLFB was used to collect data on daily use from the prior assessment to the current assessment. Thus, the TLFB was used to collect 365 continuous days of data on daily drug use after randomization. TLFB interview uses a calendar and other memory prompts to stimulate recall to obtain retrospective reports of daily substance use. Urine drug screens were conducted using Sure Step 10 urine drug screens and urine cups, which included temperature controlled monitoring and detection of adulterants. Urine drug screens were administered immediately prior to the administration of the TLFB to improve the chances of accurate reporting of days of use. The higher the median number, the more drug use; minimum median of drug use 0 days and maximum median of 28 days.|Number of self reported drug use days from 28 days prior to baseline|The number of participants analyzed represents the number of participants that completed the baseline time point, assessing for the past 28 days. It was not necessary for the participant to complete other time points in order to be analyzed for the current time point.||days of drug use 28 days prior baseline||Inter-Quartile Range|Median
173711|NCT00095238|Secondary|Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)|Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator.|Baseline, Final Visit|Randomized subjects (total=4128) with no prior AF history or evidence of AF on baseline ECG, stratified by use of ACE-I||participants|||Number
173714|NCT00095238|Secondary|Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints|Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized participants with no prior diabetes history||percentage of participants|||Number
173989|NCT00094809|Secondary|Dose Delay or Reduction for Any Reason|Dose delay or reduction in chemotherapy dose during the first 4 cycles for any reason|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
173715|NCT00095238|Secondary|Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints|Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.|Year 1, Year 2, Year 3, Year 4, Year 5|||percentage of participants|||Number
173716|NCT00095238|Secondary|Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints|Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.|Year 1, Year 2, Year 3, Year 4, Year 5|randomized participants||percentage of participants|||Number
173717|NCT00095238|Secondary|Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants||Participants|||Number
173718|NCT00095238|Secondary|Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants||Participants|||Number
173719|NCT00095238|Secondary|Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline|Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized Participants||Participants|||Number
173720|NCT00095238|Secondary|Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline|This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.|Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|||participants|||Number
173721|NCT00095238|Secondary|Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit|NYHA functional classification=4-tiered system relating symptoms to everyday activities & quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form [CRF] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event.|Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Randomized participants with measurement at baseline and Month 6, Month 10, Month 14, and Final Visit||participants|||Number
173722|NCT00095238|Secondary|Percentage of Participants Experiencing All-cause Death at Given Time Points|Treatment comparisons for time to all-cause death|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized subjects||percentage of participants|||Number
173723|NCT00095238|Secondary|Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints|Treatment comparisons for time to cardiovascular death|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Subjects||percentage of participants|||Number
173724|NCT00095238|Secondary|Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints|Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants||percentage of participants|||Number
173725|NCT00095238|Secondary|Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14|Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values.|Baseline, Month 6, Month 14|number of participants with measurement at baseline and at timepoint||pg/mL||Standard Error|Geometric Mean
173726|NCT00095238|Secondary|Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit|Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.|Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.|Participants with baseline score and score at timepoint.||units on a scale||Standard Error|Mean
173727|NCT00095238|Secondary|Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14|Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.|Baseline, Month 6, Month 14|Participants with baseline score and score at timepoint.||units on a scale||Standard Error|Mean
173728|NCT00095238|Secondary|Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points|Treatment comparisons for time to heart failure mortality or heart failure hospitalization|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants||percentage of participants|||Number
173729|NCT00095238|Primary|Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints|Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.|Year 1, Year 2, Year 3, Year 4, Year 5|Randomized Participants||percentage of participants|||Number
173730|NCT00095212|Secondary|Strength: Total Knee Extension Performed Via Quantitative Muscle Function Testing.|Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds.|Baseline (time 0) to 18 months|data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete testing.||kilograms||Standard Error|Mean
173731|NCT00095212|Secondary|Strength: Total Knee Flexion Performed Via Quantitative Muscle Function Testing.|Represents change in isometric force (measured in kilograms) from baseline to 18 months. Peak isometric force of total knee flexion and extension were measured on the best of 2 repetitions for which subjects held a maximum contraction for 5 seconds.|Baseline (time 0) to 18 months|data not available for all subjects due to malfunctioning equipment at some sessions, and some subjects did not wish to complete testing.||kilograms||Standard Error|Mean
173732|NCT00095212|Secondary|"Neurocognitive Function: Hopkins Verbal Learning Test-revised,Total Recall Z Score Represents Change in Z Score From Baseline to 18 Months."|This test assesses verbal learning and memory. Subjects are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate trials. The Total Recall Z score is calculated based on the sum of total correct responses for Trials 1,2,& 3. A Z score of 0 equals the 50 percentile, a Z score of 1 is 1 standard deviation above the mean and a Z score of -1 is 1 standard deviation below the mean. The lowest and highest T scores for the HVLT-R are ≤20 and ≥80. This correlates to lowest and highest Z scores of ≤ -3.0 and ≥3.0. A lower Z score is indicative of poor recall.|Baseline (time 0) to 18 months|data not available for all subjects as some did not wish to complete the testing||Units on a scale||Standard Error|Mean
173733|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Change in Menstrual Status (Reported More Than One Period in 1 Month or Missed a Period During a Monthly Cycle)|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months|||participants|||Number
173734|NCT00095212|Secondary|Safety: Number of Subjects Reporting Acne|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months|||participants|||Number
173735|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Change in Hair Pattern (Increased Hair on Chin, Upper Lip, Chest, Abdomen, Fore Arms, and Legs)|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months|||participants|||Number
173736|NCT00095212|Secondary|Safety: Number of Subjects Reporting a Skin Reaction to the Patch|Represents number of subjects who reported this symptom from baseline to 18 months. Every 6 weeks,subjects were counseled on appropriate barrier contraception methods and a urine pregnancy was performed. Subjects who experienced increased hair growth (facial hair) could remain in the study on a lower dose of testosterone (1 patch per week), but dose reductions were not necessary and full dosing was continued throughout the study for all subjects. Changes in menstrual status, missed periods and/or irregular bleeding, were noted and reported back to the primary care physician if significant.|Baseline (time 0) to 18 months|||participants|||Number
173737|NCT00095212|Secondary|Quality of Life/Sexual Function: Brief Index of Sexual Function (BISF-W) Domain 7: Problems Affecting Sexual Function|Represents change in measure from baseline to 18 months. The BISF is 22 items with seven domains: Thoughts and Desires, Arousal, Frequency of Sexual Activity, Receptivity/Initiation, Pleasure, Relationship Satisfaction, and Problems Affecting Sexual Function. Data from Domain 7: Problems Affecting Sexual Function is reported. The score range for this domain is -16 to 75,a higher score indicates greater sexual function.|Baseline (time 0) to 18 months|data not available for all subjects as some did not wish to complete the questionnaire||Units on a scale||Standard Error|Mean
173738|NCT00095212|Secondary|Quality of Life/Depression: Becks Depression Inventory|Represents change in the mean score from baseline to 18 months. Depression was evaluated with the Beck’s Depression Inventory (BDI). The BDI is a 21-item self-report instrument used to assess the presence and severity of symptoms of depression. A Total score in the range of 0-13 is considered minimal, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.|Baseline (time 0) to 18 months|||Units on a scale||Standard Error|Mean
173739|NCT00095212|Secondary|Bone Mineral Density of the Hip|Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for bone mineral density of the hip measured by dual energy absorptiometry (DEXA)scan.|Baseline (time 0) to 18 months|||grams per centimeter squared||Standard Error|Mean
173740|NCT00095212|Primary|Lean Body Mass|Represents change in measure from baseline to 18 months. 18 month mean and standard error of the mean for lean body mass measured by dual energy absorptiometry (DEXA)scan.|Baseline (time 0) to 18 months|Responses at 9 and 18 months were pooled as the post treatment repeated measures. All data were included in the analysis, including 9 month data from the 4 subjects who discontinued after the 9 month visit.||kilograms||Standard Error|Mean
173741|NCT00095199|Secondary|Number of Participants With Common Toxicity Criteria (CTC) Grade 3 or 4 Toxicities|National Cancer Institutes-Common Toxicity Criteria version 3.0 was used by investigators to assess participant toxicities. Mapping of investigator verbatim terms to CTCAE terms was done by the sponsor/designee using CTCAE v4.0. Participants reported had grade 3 or 4 toxicities (or both potentially). Grade 3 AEs: severe or medically significant but not immediately life-threatening;hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 AEs: life-threatening consequences; urgent intervention indicated.|Time from first dose to 30 days after last dose of study therapy up to 28.3 months for Cetuximab & Pemetrexed (versus Pemetrexed alone) and up to 54.3 months for Cetuximab + Docetaxel (versus Docetaxel alone)|All randomized participants receiving at least 1 dose of study drug made up the safety population for this outcome measure. Investigators graded events using CTCAE v3.0. Mapping of investigator verbatim terms for toxicity to CTCAE terms was done by the sponsor/designee using CTCAE v4.0.||participants|||Number
173742|NCT00095199|Secondary|Duration of Overall Response (OR)|The duration of response, in participants with best OR of complete response (CR) or partial response (PR), was measured from the date criteria are met for CR/PR (not confirmation date, whichever was first recorded), until the first occurrence date that the criteria of progressive disease (PD) was met, or death. Participants who were alive and without progression were censored at the date of their last independent review committee (IRC) tumor assessment. The tumor response and progression were assessed by the IRC in the Pemetrexed group and by the investigator in the Docetaxel group.|Time of first occurrence of either (PR) or (CR) to the first date of progressive disease or death up to 32.5 months|All randomized participants with a best overall response of CR or PR. Censored participants: 1 in Cetuximab plus Pemetrexed arm; 2 in Pemetrexed arm; 1 in Cetuximab plus Docetaxel arm; 0 in Docetaxel arm.||months||95% Confidence Interval|Median
173743|NCT00095199|Secondary|Time to Symptomatic Progression|The FACT-LCS (see description in Outcome measure 5) inventories problems specific to lung cancer symptoms. Using this Scale, Symptom progression = a ≥ 2 point decrease from baseline in LCS score maintained for 2 consecutive assessments ≥3 weeks, and <5 weeks, apart. The symptom progression date = the first of 2 consecutive assessments with a ≥2 point decline. Time to symptomatic progression = the time from randomization to the symptom progression date. For participants with no symptom progression, time to symptomatic progression was censored the date of last symptom assessment.|Randomization until symptomatic progression up to 48.3 months|All randomized participants with a baseline LCS >= 2 were included. Censored participants: 237 in Cetuximab plus Pemetrexed arm; 244 in Pemetrexed arm; 126 in Cetuximab plus Docetaxel arm; 131 in Docetaxel arm.||months||95% Confidence Interval|Median
173744|NCT00095199|Secondary|Percentage of Participants With Symptomatic Response (Symptom Response Rates) Using the Lung Cancer Subscale (LCS) Scores of Functional Assessment of Cancer Therapy for Participants With Lung Cancer (FACT-L)|The FACT-LCS is a set of 7 questions to inventory problems specific to lung cancer symptoms. Participants rate each item on a 5-point Likert-type scale from 0 (not at all) to 4 (very much). Scores range from 0-28 and higher score indicates fewer symptoms. Symptom response (improvement) was defined as ≥2 point increase from baseline in the 7-item LCS score that was maintained for 2 consecutive assessments at least 3 weeks, and not >5 weeks apart for participants, whose baseline LCS score was ≤26. Symptom response rate was the percentage of participants with symptomatic response.|At baseline, every 3 weeks and 30 days after end of therapy up to 50 months|The randomized participants with baseline LCS scores less than or equal to 26.||percentage of participants||95% Confidence Interval|Number
173745|NCT00095199|Secondary|Proportion of Randomized Participants With Best Overall Response (OR) of Partial Response (PR), Complete Response (CR), or Stable Disease (SD)|The disease control rate (DCR) was the proportion of randomized participants with a best OR of CR, PR or SD according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR, PR or SD divided by the total number of participants randomized in that arm. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.|Randomization to progression of disease or death due to any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received.||proportion of participants||95% Confidence Interval|Number
173746|NCT00095199|Secondary|Proportion of Randomized Participants With the Best Overall Response (OR) of Partial Response (PR) or Complete Response (CR) (Overall Response Rate [ORR])|The best overall response rate (ORR) was the proportion of randomized participants with a best OR of CR or PR, according to modified World Health Organization (WHO) guidelines. It was calculated as the total number of participants with CR or PR divided by the total number of participants treated in that arm. Participants with no post-baseline evaluation were considered as non-responders. The tumor response was assessed by the independent review committee (IRC) in the Pemetrexed group and by the investigator in the Docetaxel group.|Randomization until progression of disease or death from any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received.||proportion of participants||95% Confidence Interval|Number
173747|NCT00095199|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death. Participants without a date of death were censored on the last date participants were known to be alive, or lost to follow-up.|Randomization to the date of death from any cause up to 72.8 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. Censored participants: 24 in Cetuximab + Pemetrexed arm; 43 in Pemetrexed arm; 12 in Cetuximab + Docetaxel arm; 22 in Docetaxel arm.||months||95% Confidence Interval|Median
173748|NCT00095199|Primary|Progression Free Survival (PFS)|PFS was defined as the time from randomization until the date of progressive disease (PD) or death from any cause. Participants who were alive and without progression were censored at the date of their last tumor assessment. PFS was assessed by the independent review committee (IRC) in the Pemetrexed group (Cetuximab & Pemetrexed versus Pemetrexed) and by the investigator in the Docetaxel group (Cetuximab & Docetaxel versus Docetaxel).|Randomization to progression of disease or death due to any cause up to 59.6 months|The intent-to-treat population (ITT) included all participants classified according to the treatment arms into which they were randomized, regardless of the actual treatment received. Censored participants: 10 in Cetuximab + Pemetrexed arm; 25 in Pemetrexed arm; 6 in Cetuximab + Docetaxel arm; 16 in Docetaxel arm.||months||95% Confidence Interval|Median
173749|NCT00095173|Secondary|Number of Participants With Anti-Abatacept or Anti-CTLA4 Positive Responses Over Time During Open-Label Phase (Period C)|During Period C, blood samples for immunogenicity assessments were obtained just prior to the start of the IV infusion of abatacept at 3-month intervals during the first 2 years of Period C, at 6-month intervals thereafter, and again 28, 56, and 85 days after the last infusion. Direct-format, enzyme-linked immunosorbent assays (ELISAs) were used to evaluate the cytotoxic T-lymphocyte antigen 4 (CTLA4) and the anti-CTLA4-T antibody.|Period C (Day 282 to 85 days after the last dose of study medication)|All treated participants who were evaluated for immunogenicity during Period C||participants|||Number
173750|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Phase (Period C)|Marked abnormalities were pre-defined as changes in lab tests after drug infusion and relative to normal range. Hemoglobin,11.6-14.8grams per deciliter(g/dL);Hematocrit,36.0-50.0 percent;Erythrocytes,3.80-5.10x10*6 cells per microliter(c/uL);Platelets,140-44 cells per liter(c/L);Leukocytes,4.00-12.50c/uL;Absolute(Abs)Neutrophils+Bands,<1.00x10^3 c/uL;Abs Lymphocytes,<0.72x10^3 or>7.50x10^3 c/uL;Abs Eosinophils,>0.750X10^3 c/uL;Alkaline Phosphatase,0-40 units per liter(U/L);Aspartate Aminotransferase,0-40 U/L;Alanine Aminotransferase,0-40U/L;G-Glutamyl Transferase,0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter(mg/dL);Blood Urea Nitrogen,5.9-26.0 mg/dL;Creatinine, 0.50-1.50mg/dL;Inorganic Phosphorus,2.8-6.2 U/L;Serum Potassium,3.5-5.5 milliequivalents per liter(mEq/L);Serum Glucose,65-99 mg/dL;Fasting Serum Glucose,65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin,3.5-5.5 g/dL;Urine Protein,>=4;Urine Glucose,>=4;Urine Blood,>=4;Urine Red Blood Cells>=4;Urine White Blood Cells,>=4.|Period C (Day 282 to end of study)|All treated participants in Period C evaluated for a specific analyte.||participants|||Number
173751|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Double-Blind Phase (Period B)|Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if <1.00x10^3 c/uL;Absolute Lymphocytes, if <0.72x10^3 or >7.50x10^3 c/uL;Absolute Eosinophils, if >0.750X10^3 c/uL;Aspartate Aminotransferase, 0-40 units per liter (U/L); Alanine Aminotransferase, 0-40 U/L;Blood Urea Nitrogen, 5.9-26.0 mg/dL;Serum Sodium, 135-148 milliequivalents per liter (mEq/L);Serum Potassium, 3.5-5.5 mEq/L;Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Urine Protein, >=4;Urine Blood, >=4;Urine Red Blood Cells >=4;Urine White Blood Cells, >=4.|Period B (Day 113 to Day 282)|All treated participants in Period B evaluated for a specific analyte.||participants|||Number
173752|NCT00095173|Secondary|Number of Treated Participants With Marked Laboratory Abnormalities During Open-Label Lead-In Phase (Period A)|Marked abnormalities were pre-defined as changes in lab tests that occurred after drug infusion and were reported relative to the normal range for each analyte. Hemoglobin, 11.6-14.8 grams per deciliter (g/dL);Hematocrit, 36.0-50.0 percent;Erythrocytes, 3.80-5.10x10*6 cells per microliter (c/uL);Platelets, 140-44 cells per liter (c/L);Leukocytes, 4.00-12.50 c/uL;Absolute Neutrophils + Bands, if <1.00x10^3 c/uL;Absolute Lymphocytes, if <0.72x10^3 or >7.50x10^3 c/uL;Absolute Eosinophils, if >0.750X10^3 c/uL;Alanine Aminotransferase, 0-40 units per liter (U/L);G-Glutamyl Transferase, 0-60 U/L;Bilirubin, 0.1-1.2 milligrams per deciliter (mg/dL);Blood Urea Nitrogen, 5.9-26.0 mg/dL;Creatinine, 0.50-1.50 mg/dL;Serum Potassium, 3.5-5.5 milliequivalents per liter (mEq/L);Serum Glucose, 65-99 mg/dL;Fasting Serum Glucose, 65-99 mg/dL;Total Protein, 6.0-8.5 g/dL;Albumin, 3.5-5.5 g/dL;Urine Protein, >=4;Urine Glucose, >=4;Urine Blood, >=4;Urine Red Blood Cells >=4;Urine White Blood Cells, >=4.|Period A (Day 1 to Day 113)|All treated participants in Period C evaluated for a specific analyte.||participants|||Number
173753|NCT00095173|Secondary|Percentage of Participants Achieving American College of Rheumatology (ACR) Pediatric 30 (ACRP30), ACR Pediatric 50, ACR Pediatric 70, ACR Pediatric 90, and Inactive Disease Status Erythrocyte Sedimentation Rate (ESR) Response Rate|The ACRP30 response criteria were defined as a ≥ 30% improvement over baseline in ESR. ACRP 50, 70, and 90 responses were defined similarly with 50%, 70%, and 90% improvements required, respectively.|Day 113, Day 282, and Day 2047|All treated participants||percentage of participants||95% Confidence Interval|Number
173754|NCT00095173|Secondary|Events of Special Interest During Open-Label Phase (Period C), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period C (Day 282 up to 56 days after the last dose of study medication)|All treated participants in Period C||participants|||Number
174364|NCT00090584|Secondary|Symptom Bother|Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.|baseline, 10 weeks and 8 months|Participants who completed OAB-q assessment at each time in each treatment group.||units on a scale||Standard Deviation|Mean
173755|NCT00095173|Secondary|Events of Special Interest During Double-Blind Phase (Period B), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period B (Day 113 to Day 282)|All treated participants in Period B||participants|||Number
173756|NCT00095173|Secondary|Events of Special Interest During Open-Label Lead-In Phase (Period A), Including Infections, Peri-Infusional Adverse Events (AEs), Autoimmune Disorders and Malignancies|The sponsor prospectively identified categories of AEs that may be associated with the use of immunomodulatory drugs including infections, peri-infusional AEs, autoimmune disorders, malignancies. Peri-infusional AEs are defined as those AEs of special interest occurring during the first 24 hours after the start of study drug infusion. Malignancies definitions were based on events in the MedDRA Maintenance and Support Services Organization (MSSO) malignancies Structured MedDRA Query (SMQ).Autoimmune disorders are in alignment with the pre-specified MedDRA codes of autoimmune disorders events of interest.|Period A (Day 1 to Day 113)|All treated participants in Period A||participants|||Number
173757|NCT00095173|Secondary|Median Percent Change From Baseline in JRA/JIA Core Set Variables During Open-Label Phase (Period C)|Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician's global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.|Period C (Day 282 to end of study)|All treated participants in Period C||percentage change from baseline||Inter-Quartile Range|Median
173758|NCT00095173|Secondary|Median Percent Change From Baseline in JRA/JIA Core Set Variables During Double-Blind Phase (Period B)|Percent change from baseline was calculated from the difference between post-baseline and baseline divided by baseline multiplied by 100 and reported as the range between 25th and 75th percentile, not full range; American College of Rheumatology (ACR) Pediatric 30 JRA/JIA core set variables include active joints, limited range of motion, physician global assessment of disease severity, parent global assessment of overall well-being, change in physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Disease activity was assessed by the physician and parent on a 0-100 mm visual analog scale (VAS). Low values represent low severity of disease and good well-being whereas high values represent highly severe disease and very poor well-being.|Period B (Day 113 to Day 282)|All treated participants in Period B||percentage change from baseline||Inter-Quartile Range|Median
173759|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Phase (Period C)|AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 85 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1).|Period C (Day 282 to end of study)|All treated participants in Period C||participants|||Number
173760|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Double-Blind Phase (Period B)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1)."|Period B (Day 113 to Day 282)|All treated participants in Periods B||participants|||Number
173761|NCT00095173|Secondary|Number of Participants With Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs During Open-Label Lead-In Phase (Period A)|"AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment.~SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during the study and up to 28 days past study discontinuation. The select AEs were determined using the Medical Dictionary for Regulatory Activities (MedDRA, v14.1)."|Period A (Day 1 to Day 113)|All treated participants in Periods A||participants|||Number
173762|NCT00095173|Secondary|Number of Participants With a Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease With a Flare During Double-Blind Phase (Period B)|"All of the following criteria must be met to be defined as a flare:~> 30% worsening in at least 3 of the 6 JRA/JIA core response variables~> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables~≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare~worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)"|Period B (Day 113 to Day 282)|All treated participants||participants|||Number
173763|NCT00095173|Primary|Time to Occurrence of Juvenile Rheumatoid Arthritis/Juvenile Idiopathic Arthritis (JRA/JIA) Disease Flare During Double-Blind Phase (Period B)|"Time to flare is defined as the elapsed number of days between the first dose date in Period B and the study day that disease flare is confirmed.~All of the following criteria must be met to be defined as a flare:~> 30% worsening in at least 3 of the 6 JRA/JIA core response variables~> 30% improvement in not more than 1 of the 6 JRA/JIA core set variables~≥ 2 cm of worsening must be present if the Physician or Parent Global Assessment is used to define flare~worsening in ≥ 2 joints must be present if the number of active joints or joints with limitation of motion is used to define flare based on changes in the surrogate marker, erythrocyte sedimentation rate (ESR)"|Period B (Day 113 to Day 282)|All treated participants||months||Full Range|Median
173764|NCT00095147|Primary|OL; Mean Temperature (T) During Open Label Period|Temperature (T), units=degrees Celcius|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.||degrees Celsius||Standard Deviation|Mean
173765|NCT00095147|Primary|OL; Mean Heart Rate (HR) During Open Label Period|Heart Rate (HR), units=beats per minute (bpm)|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.||beats per minute (bpm)||Standard Deviation|Mean
173766|NCT00095147|Primary|OL; Mean Systolic (SBP) and Diastolic (DBP) Blood Pressure During Open Label Period|Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), units=mm mercury (Hg)|Days 365, 729, 1121, and 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.n=number of participants with data available.||mm mercury (Hg)||Standard Deviation|Mean
173767|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||U/L||Standard Error|Mean
173768|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mg/dL||Standard Error|Mean
173769|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mEq/L||Standard Error|Mean
173770|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^6 c/uL||Standard Error|Mean
173771|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^3 c/uL||Standard Error|Mean
173772|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||percentage of red blood cells||Standard Error|Mean
173773|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^9 c/L||Standard Error|Mean
173774|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1513 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 1513|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||g/dL||Standard Error|Mean
173775|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||U/L||Standard Error|Mean
173776|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mg/dL||Standard Error|Mean
173777|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mEq/L||Standard Error|Mean
173778|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^6 c/uL||Standard Error|Mean
173779|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^3 c/uL||Standard Error|Mean
173780|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||percentage of red blood cells||Standard Error|Mean
173781|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^9 c/L||Standard Error|Mean
173782|NCT00095147|Primary|OL; Mean Change From Baseline to Day 1121 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 1121|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||g/dL||Standard Error|Mean
173783|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||U/L||Standard Error|Mean
173784|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mg/dL||Standard Error|Mean
173785|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mEq/L||Standard Error|Mean
173786|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^6 c/uL||Standard Error|Mean
173787|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^3 c/uL||Standard Error|Mean
173797|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||g/dL||Standard Error|Mean
173788|NCT00095147|Secondary|OL; Adjusted Mean Change From Baseline to Day 729 in HAQ-DI|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Day 1 (Baseline), Day 729|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.||units on a scale||Standard Error|Mean
173789|NCT00095147|Secondary|OL; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response Over Time|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|OL Days 197, 253, 281, 309, 337, 365, 449, 533, 617, and 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.||percentage of participants|||Number
173790|NCT00095147|Secondary|OL; Percentage of Participants Who Achieved Major Clinical Response|Major Clinical Response was defined as a continuous ACR 70 for six months.|Defined from the date of achieving ACR 70 response to 6 months post response|Protocol-specified analyses of the proportion of participants achieving a Major Clinical Response were not performed since ACR responses in the open-label period could only be assessed at 6-month intervals due to the fact that CRP and ESR were only measured every 6 months during this period.|||||
173791|NCT00095147|Secondary|OL; Percentage of Participants With American College of Rheumatology (ACR) Responses Over Time|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 197, Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||percentage of participants|||Number
173792|NCT00095147|Secondary|OL; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Over Time|The DAS28 is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute >5.1 or <0.6 change from BL)|DB Days 365, 533, and 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.||percentage of participants|||Number
173793|NCT00095147|Secondary|OL; Percentage of Participants With DAS28 (ESR) Remission and Low Disease Activity (LDAS) Over Time|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Efficacy data was summarized for the 3 DB treatment cohorts.n=number of participants with data available.||percentage of participants|||Number
173794|NCT00095147|Secondary|OL; Mean Change From Baseline Over Time in DAS 28 (ESR) Score|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), Day 365, Day 533, Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period.n=number of participants with data available.||units on a scale||Standard Error|Mean
173795|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||percentage of red blood cells||Standard Error|Mean
173796|NCT00095147|Primary|OL; Mean Change From Baseline to Day 729 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 729|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^9 c/L||Standard Error|Mean
173798|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Alanine Aminotransferase, Aspartate Aminotransferase, G-Glutamyl Transferase, and Alkaline Phosphatase|alanine aminotransferase (ALT): >3 x ULN; aspartate aminotransferase (AST): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Alkaline phosphatase (ALP): >2 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||U/L||Standard Error|Mean
173799|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Bilirubin, Blood Urea Nitrogen, Creatinine, Calcium, Phosphorous, Serum Glucose, Fasting Serum Glucose, and Uric Acid|Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL; calcium (Ca): <0.8 x LLN, >1.2 x ULN; phosphorous (P): <0.75 x LLN, >1.2 5 x ULN; serum glucose (Glu): <65 mg/dL, >220 mg/dL; fasting serum Glu: <0.8 x LLN, >1.5 x ULN; uric acid: >1.5 x ULN;|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mg/dL||Standard Error|Mean
173800|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Electrolytes|Sodium (Na): <0.95 x LLN, >1.05 x ULN; potassium (K): <0.9 x LLN, >1.1 x ULN; chloride (Cl): <0.9 x LLN, >1.1 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||mEq/L||Standard Error|Mean
173801|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Erythrocytes|Erythrocytes: <0.75 x BL|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^6 c/uL||Standard Error|Mean
173802|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in White Blood Cells|Leukocytes: <0.75 x LLN, >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; eosinophils: >0.750 x 10^3 c/uL; basophils: > 400 mm3; monocytes: >2000 mm3; lymphocytes: <0.750 x 10^3 c/uL, >7.50 x 10^3 c/uL.|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^3 c/uL||Standard Error|Mean
173803|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Hematocrit|Hematocrit: <0.75 x BL|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||percentage red blood cells||Standard Error|Mean
173804|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Platelets|Platelets (PLT): <0.67 x LLN, >1.5 x ULN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||10^9 c/L||Standard Error|Mean
173805|NCT00095147|Primary|OL; Mean Change From Baseline to Day 365 in Hemoglobin, Total Protein, and Albumin|Hemoglobin (HGB): >3 g/dL decrease from BL; total protein: < 0.9 x LLN, >1.1 x ULN; albumin:<0.9 x LLN|Baseline (Day 1), Day 365|Number of Participants Analyzed=All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period. Treatment groups represent treatment received in the DB period. n=number of participants with data available.||g/dL||Standard Error|Mean
173806|NCT00095147|Secondary|DB; Percentage of Participants With Antibodies Against Infliximab (Human Anti-chimeric Antibody [HACA]) From Day 1 Through Day 365|Infliximab levels were measured using a microplate enzyme-linked immunosorbant assay (ELISA) with infliximab bound to immobilized recombinant tumor necrosis factor (TNF)-alpha. Bound infliximab is detected utilizing a horseradish peroxidase-conjugated anti-human IgG Fc(fragment, crystallizable region)-specific). The enzyme turns over the substrate O-phenlenediamine to a chromogenic product that is measured at 490 nm. The cut-off value was 1.40 ug/mL; this was based on the mean (+ 3 SD) value in serum samples from 40 participants who had never received infliximab.|Day 1 through day 365|The immunogenicity analysis population included participants who received at least one dose of infliximab and had immunogenicity samples collected at baseline and at least one post-baseline treatment visit.||percentage of participants|||Number
173807|NCT00095147|Secondary|DB; Number of Participants With Anti-Abatacept Antibodies From Day 1 Through Day 365 (Electrochemiluminescent [ECL] Immunoassay)|ECL screened sera for drug-specific antibodies, immunocompetition was used to identify specific anti-Abatacept reactivity. Cytotoxic leukocyte antigen 4 (CTLA4) and Possibly Immunoglobulin (Ig) Category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction Category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity was defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing.|Day 1 through day 365|The immunogenicity analysis population included participants who received at least one dose of abatacept and had immunogenicity samples collected at baseline and at least one post-baseline treatment visit.||participants|||Number
173808|NCT00095147|Secondary|DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 365|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; creatinine: >4 x BL|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
173809|NCT00095147|Secondary|DB; Number of Participants With Select Hematologic and Blood Chemistry Laboratory Abnormalities on Days 1 Through 197|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; creatinine: >4 x BL|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
173810|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Temperature During Days 1 Through 197 and Days 1 Through 365|Temperature (T) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|As Treated Population.||participants|||Number
173811|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Heart Rate During Days 1 Through 197 and Days 1 Through 365|Heart Rate (HR) was assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study|As Treated Population.||participants|||Number
173812|NCT00095147|Secondary|DB; Number of Participants With Significant Changes in Mean Systolic and Diastolic Blood Pressure During Days 1 Through 197 and Days 1 Through 365|Seated Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) were assessed as clinically significant or relevant at the discretion of the Clinical Investigator. Criteria may have varied between institutions.|From Baseline (Day 1) through Day 197, or Day 1 through Day 365, and up to 56 days after last dose if occurring on-study|As-Treated Population||participants|||Number
173813|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
173814|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 365|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
173815|NCT00095147|Primary|OL; Number of Participants With Select Blood Chemistry Laboratory Abnormalities|Low=lower than LLN, High=greater than ULN. LLN/ULN= Alkaline phosphatase (ALP): >2 x ULN; aspartate aminotransferase (AST): >3 x ULN; alanine aminotransferase (ALT): >3 x ULN; G-Glutamyl transferase (GGT): >2 x ULN; Bilirubin: >2 x ULN; blood urea nitrogen (BUN): >2 x BL; creatinine: >4 x BL|From Day 366 through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.||participants|||Number
173816|NCT00095147|Primary|OL; Number of Participants With Select Hematologic Laboratory Abnormalities|High=greater than Upper Normal Limit (ULN), Low=lower than Lower Normal Limit (LLN). LLN/ULN= Hemoglobin (HGB): >3 g/dL decrease from Baseline (BL); Hematocrit: <0.75 x BL; Erythrocytes: <0.75 x BL; Platelets (PLT): <0.67 x LLN/>1.5 x ULN; Leukocytes: <0.75 x LLN/ >1.25 x ULN; neutrophils+bands: <1.0 x 10^3 c/uL; lymphocytes: <0.750 x 10^3 c/uL/ >7.50 x 10^3 c/uL; monocytes: >2000 mm3; eosinophils: >0.750 x 10^3 c/uL;|From Day 366 through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.||participants|||Number
173817|NCT00095147|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.||participants|||Number
173818|NCT00095147|Primary|OL; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, and AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From beginning of OL (Day 366) through end of OL (range from 1.9 months to 42.3 months)|All Treated Population, all participants who entered the open-label period and received at least one dose of abatacept at any time during this period.||participants|||Number
173819|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 198 Through Day 365 in Participants Receiving Placebo Switched to Abatacept|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Day 198 through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
173820|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 365|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Baseline (Day 1) through Day 365, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
173821|NCT00095147|Secondary|DB; Number of Participants With AEs of Special Interest From Day 1 Through Day 197|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, autoimmune disorders; malignancies; and acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion).|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
173822|NCT00095147|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, and AEs Leading to Discontinuation From Day 1 Through Day 197|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|From Baseline (Day 1) through Day 197, and up to 56 days after last dose if occurring on-study|The As-Treated analysis population contained all participants who received at least one dose of double-blind study medication, and participants were grouped on an as-assigned or randomized basis unless the participant received the incorrect medication for the entire period of treatment.||participants|||Number
173823|NCT00095147|Secondary|DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 365|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||percentage of participants|||Number
173824|NCT00095147|Secondary|DB; Percentage of Participants With American College of Rheumatology (ACR) Responses at Day 197|The ACR 20 definition of improvement is a 20% improvement from baseline in the number of tender and swollen joint counts, and a 20% improvement from baseline in 3 of the remaining 5 core set measures: participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function and acute phase reactant value (C-reactive protein [CRP]). The evaluation for 50% improvement (ACR 50) and 70% improvement (ACR 70) follow similarly.|DB Day 197|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||percentage of participants|||Number
173825|NCT00095147|Secondary|DB; Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) at Day 365|The DAS28 is a continuous disease measure composite of 4 variables: 28 tender joint count, 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. High disease activity= > 5.1, low disease activity= < 3.2, and remission= < 2.6. Clinically significant response= decrease of >1.2 from baseline. Utilizing EULAR response criteria, DAS28 categorical responses define a good (absolute: <3.2 or >1.2 improvement from baseline [BL]), moderate (absolute: 3.2-5.1 or 0.6-1.2 change from BL), or no response (absolute: >5.1 or <0.6 change from BL)|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||percentage of participants|||Number
173826|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 365 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), 12 months (Day 365)|ITT Population: all participants randomized into the study receiving study medication, grouped according to randomization treatment. Although 3 participants in PLA group discontinued before Day 197, 2 of these patients were included in the LOCF analysis. SF-36 component scores were not presented in tabular form.||units on a scale||Standard Error|Mean
173827|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS)|The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health; (2) mental component summary=vitality, social functioning, role-emotional, and mental health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.|Baseline (Day 1), 6 months (Day 197)|ITT population, all participants randomized into the study receiving study medication. Participants grouped according to the treatment to which they were randomized. All randomized participants who never received study medication were excluded. SF-36 component scores were not presented in tabular form.||units on a scale||Standard Error|Mean
173828|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 365 in HAQ-DI (LOCF Analysis)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Baseline (Day 1), 12 months (Day 365)|Intent-to-Treat (ITT) Population: all participants randomized into the study receiving study medication, grouped according to randomization treatment. All participants randomized but never receiving study medication excluded. Although 3 participants in PLA group discontinued before Day 197, 2 of these patients were included in the LOCF analysis.||units on a scale||Standard Error|Mean
173829|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in HAQ-DI (LOCF Analysis)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||units on a scale||Standard Error|Mean
173830|NCT00095147|Secondary|DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 365|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|DB Day 365|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||percentage of participants|||Number
173831|NCT00095147|Secondary|DB; Percentage of Participants With Clinically Meaningful Health Assessment Questionnaire-Disability Index (HAQ-DI) Response at Day 197|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|DB Day 197|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||percentage of participants|||Number
173840|NCT00095121|Secondary|Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss or Seroconversion by End of Blinded Treatment (Study Week 48; Randomized and Treated Analysis Set)|HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and hepatitis B e antibody + (anti-HBe+) post baseline.|Study Week 0 to Study Week 48 (double-blind period)|The randomized and treated analysis set included all participants who were randomized into the study and received at least one dose of study medication. For Week 48 data; if Week 48 was missing, Week 44 was carried forward; if Week 44 was missing, missing = failure.||percentage of participants|||Number
173832|NCT00095147|Secondary|DB; DAS 28 (ESR) Area Under The Curve (AUC) Over 12 Months For ABA Versus INF|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Clinically significant response= decrease in DAS28 score of >1.2 from baseline. DAS28 AUC can be calculated from the DAS28 score versus time curve, which provides an assessment of changes in disease activity over time.|From Day 1 through Day 365 (12 months)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||units on a scale||Standard Deviation|Mean
173833|NCT00095147|Secondary|DB; Adjusted Mean Change From Baseline to Day 197 in DAS 28 Score (ESR) For INF Versus PLA (LOCF Analysis)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||units on a scale||Standard Error|Mean
173834|NCT00095147|Primary|DB; Adjusted Mean Change From Baseline to Day 197 in Disease Activity Score (DAS) 28 Score (Erythrocyte Sedimentation Rate [ESR]) For ABA Versus PLA (Last Observation Carried Forward [LOCF] Analysis)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or C-reactive protein (CRP), and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response is a decrease in DAS28 score of >1.2 from baseline.|Baseline (Day 1), 6 months (Day 197)|The Intent-to-Treat (ITT) analysis population was defined to include all participants randomized into the study who received study medication. Participants were grouped according to the treatment or treatment regimen to which they were randomized. All participants who were randomized but never received study medication were excluded.||units on a scale||Standard Error|Mean
173835|NCT00095121|Secondary|Percentage of Participants With Durable HBeAg Seroconversion|A participant was defined to have durable HBeAg seroconversion only if she/he remained in a seroconverted state (HBeAg−, hepatitis B e antibody + [anti-HBe+]) from the date that she/he first seroconverted through and including her/his last study visit. This endpoint could only be assessed for participants who (HBeAg−) seroconverted on-treatment and subsequently discontinued open-label dosing.|240 weeks|Participants who discontinued treatment because of confirmed HBeAg seroconversion in Weeks 49 to 240 were to remain in the study through Week 240 to monitor the durability of seroconversion. Any participant who formally stopped drug early and restarted, by definition, did not have durable HBeAg seroconversion.||Percentage of participants|||Number
173836|NCT00095121|Secondary|Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance) for Subjects Who Received Combination ADV + Lamivudine Therapy|Resistance surveillance was conducted at Week 240/last on-treatment study visit for all participants who had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR while on combination ADV + lamivudine treatment.|240 weeks|32/173 added lamivudine from Weeks 108 - 144. Last on-ADV sample through Week 240 analyzed; participant omitted from cumulative Week 240 analysis if HBV DNA <169 copies/mL at Week 240/last time point or stopped study drug but remained in study. 2 ADV-ADV participants had ADV/lamivudine-specific, conserved-site mutation, and counted 2x in table.||Participants|||Number
173837|NCT00095121|Secondary|Cumulative Summary of Participants With HBV Genotypic Changes From Baseline (Resistance Surveillance)|Resistance surveillance was conducted annually for all participants who remained on treatment and had HBV DNA concentrations greater than or equal to the level of detection (>= 169 copies/mL) by PCR. The last on-ADV sample for all participants in the study was analyzed in the cumulative Week 240 resistance surveillance analysis.|240 weeks|Last on-ADV sample through Week 240 was analyzed, and participant was excluded from the cumulative Week 240 analysis if HBV DNA value was < 169 copies/mL at Week 240/last time point or if participant discontinued study drug but remained in study. One ADV-ADV participant had an ADV-specific, conserved-site mutation and is counted twice in the table.||Participants|||Number
173838|NCT00095121|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 240 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)|Per protocol, participants could discontinue study medication due to HBeAg seroconversion and remain in the study in order to evaluate the durability of seroconversion. HBeAg loss is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and anti-HBe+ post baseline.|ADV baseline to ADV Week 240|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were excluded. Analysis set included only data from participants while on study treatment.||percentage of participants|||Number
173839|NCT00095121|Secondary|Percentage of Participants With HBeAg Loss or Seroconversion by ADV Week 192 (Open Label Analysis Set, Participants Who Were HBeAg Positive at ADV Baseline; Missing = Excluded)|ADV baseline = 1st ADV-dose day = Week 0 for ADV-ADV group and Week 48 for PLB-ADV group. ADV week = windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). HBeAg loss is defined per individual participant as HBeAg+ at ADV baseline and HBeAg− post baseline. HBeAg seroconversion is defined for an individual participant as HBeAg+ at ADV baseline and HBeAg− and anti-HBe+ post baseline.|ADV baseline to ADV Week 192|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were excluded. Analysis set included only data from participants while on study treatment.||percentage of participants|||Number
173841|NCT00095121|Secondary|Percentage of Participants With Normal ALT at ADV Week 240 (Missing = Failure)|Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV Week 240|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.||percentage of participants|||Number
173842|NCT00095121|Secondary|Percentage of Participants With Normal ALT at ADV Week 192 (Missing = Failure)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV Week 192|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.||percentage of participants|||Number
173843|NCT00095121|Secondary|Percentage of Participants With Normal ALT at Adefovir Baseline (Missing = Failure)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]). Normal ALT: 0-1 year old = <=54 U/L; females 1-88 years old and males 1-10 years old = 8-34 U/L; males 10-88 years old = 8-43 U/L.|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Participants with missing values were considered as failures rather than excluded. Analysis set included only data from participants while on study treatment.||percentage of participants|||Number
173844|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 240 for ALT||ADV baseline to ADV 240 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||U/L||Standard Deviation|Mean
173845|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 192 for ALT|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV baseline to ADV 192 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||U/L||Standard Deviation|Mean
173846|NCT00095121|Secondary|ADV Baseline ALT|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||U/L||Standard Deviation|Mean
173847|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 240 for Serum HBV DNA||ADV baseline to ADV 240 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||log10 HBV DNA copies/mL||Standard Deviation|Mean
173848|NCT00095121|Secondary|Change From ADV Baseline to ADV Week 192 for Serum HBV DNA|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV baseline to ADV 192 weeks|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||log10 HBV DNA copies/mL||Standard Deviation|Mean
173849|NCT00095121|Secondary|Adefovir (ADV) Baseline Serum HBV DNA|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set included any participant who took at least one dose of open-label ADV. This analysis set was also subdivided based on DB drug, as ADV-ADV or PLB-ADV. Analysis set included only data from participants while on study treatment.||log10 HBV DNA copies/mL||Standard Deviation|Mean
173850|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 240)||ADV Week 240|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
173851|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Week 192)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV Week 192|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
173852|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 400 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
173854|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment - Missing = Failure) (ADV Week 192)|Adefovir week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240), whereas participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).|ADV Week 192|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
173855|NCT00095121|Secondary|Percentage of Participants With Serum HBV DNA < 1000 Copies/mL (PCR-based Assay) While on Treatment (Missing = Failure) (ADV Baseline)|The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group] and Week 48 for those originally randomized to placebo [PLB-ADV group]).|ADV baseline|The OL analysis set was used for this endpoint and included any participant who took at least 1 dose of open-label ADV. Participants with missing values were considered as failures rather than excluded.||percentage of participants|||Number
173856|NCT00095121|Primary|Percentage of Participants With Serum Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) < 1000 Copies/mL (Polymerase Chain Reaction [PCR]-Based Assay) and Normal Alanine Aminotransferase (ALT) at Week 48 (Missing = Failure)|In the absence of biopsy data from these pediatric participants, this endpoint enables assessments of drug effect on viral replication and the underlying degree of inflammation in the liver.|Week 48|All randomized participants who received >= 1 dose study medication. If either endpoint was missing a Week 48 value, Week 44 value was substituted and used in the combined endpoint. If participant did not have serum HBV DNA value at Weeks 44 and 48 or ALT value at Weeks 44 and 48, then participant was considered a failure for the Week-48 analysis.||percentage of participants|||Number
173857|NCT00095056|Secondary|Safety and Tolerability of Sitagliptin Over 54 Weeks|Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.|Week 0 through Week 54|All patients who took study medication were included in the analysis. Events that occurred after initiation of glycemic rescue therapy were excluded from the analysis of CAEs, drug-related CAEs, LAEs, & drug-related LAEs. Events that occurred after initiation of glycemic rescue therapy were included in the analysis of serious CAEs and serious LAEs.||Participants|||Number
173858|NCT00095056|Primary|Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment|Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment.|Week 0 through Week 12|All patients who took study medication were included in the analysis. Events that occurred after initiation of glycemic rescue therapy were excluded from the analysis of CAEs, drug-related CAEs, LAEs, & drug-related LAEs. Events that occurred after initiation of glycemic rescue therapy were included in the analysis of serious CAEs and serious LAEs.||Participants|||Number
173859|NCT00094900|Secondary|Mean Change in Prednisone Dose||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/day||Standard Error|Mean
173860|NCT00094900|Secondary|Mean Change in Prednisone Dose||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/day||Standard Error|Mean
173861|NCT00094900|Secondary|Mean Change in Prednisone Dose||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/day||Standard Error|Mean
173862|NCT00094900|Secondary|Mean Change in Prednisone Dose||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/day||Standard Error|Mean
173863|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||swollen joints||Standard Error|Mean
173864|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||swollen joints||Standard Error|Mean
173865|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||swollen joints||Standard Error|Mean
173866|NCT00094900|Secondary|Mean Change in Swollen Joint Count in AOSD Subjects|Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||swollen joints||Standard Error|Mean
173867|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||tender joints||Standard Error|Mean
174365|NCT00090584|Secondary|Symptom Distress|Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.|baseline, 10 weeks and 8 months|All women who completed UDI at each time in each treatment group||units on a scale||Standard Deviation|Mean
173868|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||tender joints||Standard Error|Mean
173869|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||tender joints||Standard Error|Mean
173870|NCT00094900|Secondary|Mean Change in Tender Joint Count in AOSD Subjects|Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||tender joints||Standard Error|Mean
173871|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||units on a scale||Standard Error|Mean
173872|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||units on a scale||Standard Error|Mean
173873|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||units on a scale||Standard Error|Mean
173874|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS in AOSD Subjects|Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||units on a scale||Standard Error|Mean
173875|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mm/hour||Standard Error|Mean
173876|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mm/hour||Standard Error|Mean
173877|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mm/hour||Standard Error|Mean
173878|NCT00094900|Secondary|Mean Change in Erythrocyte Sedimentation Rate||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mm/hour||Standard Error|Mean
173879|NCT00094900|Secondary|Mean Change in C-Reactive Protein||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/dl||Standard Error|Mean
173880|NCT00094900|Secondary|Mean Change in C-Reactive Protein||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/dl||Standard Error|Mean
173881|NCT00094900|Secondary|Mean Change in C-Reactive Protein||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/dl||Standard Error|Mean
173882|NCT00094900|Secondary|Mean Change in C-Reactive Protein||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/dl||Standard Error|Mean
173883|NCT00094900|Secondary|Mean Change in Serum Amyloid A||24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/liter||Standard Error|Mean
173884|NCT00094900|Secondary|Mean Change in Serum Amyloid A||12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/liter||Standard Error|Mean
173885|NCT00094900|Secondary|Mean Change in Serum Amyloid A||6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/liter||Standard Error|Mean
173886|NCT00094900|Secondary|Mean Change in Serum Amyloid A||3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mg/liter||Standard Error|Mean
173887|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 24 months|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mcg/L||Standard Error|Mean
173888|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 12 months|12 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mcg/L||Standard Error|Mean
173889|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 6 months|6 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mcg/L||Standard Error|Mean
173890|NCT00094900|Secondary|Mean Change in Ferritin|Ferritin level change from baseline to 3 months|3 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||mcg/L||Standard Error|Mean
173891|NCT00094900|Secondary|Mean Change in WBCs|White Blood Cell count change from baseline to 24 months|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||x 10^3 cells/microliter||Standard Error|Mean
173895|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 24 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173896|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 20 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173897|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 16 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173898|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 12 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173899|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 9 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173900|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 6 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173901|NCT00094900|Secondary|Mean Change in SF-36 Mental Component Score|Short Form 36 health survey (range 0–100 for each component score), mental component score, taken by patient from baseline to 3 months. Lower scores indicate feeling depressed, anxious all the time, while higher scores indicate a state of happiness and peacefulness. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection.Med Care 1992;30:473–83.)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173902|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 24 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173903|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 20 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173904|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 16 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173905|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 12 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173906|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 9 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173907|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 6 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Deviation|Mean
173908|NCT00094900|Secondary|Mean Change in SF-36 Physical Component Score|Short Form 36 health survey (range 0–100 for each component score), physical component score, taken by patient from baseline to 3 months. Lower scores indicate limited physical function, while higher scores indicate higher physical function. (Reference: Ware JE Jr, Sherbourne CD. The MOS 36-item Short-Form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473–83.)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173909|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 24 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
173910|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 20 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
173911|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 16 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
173912|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 12 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
173913|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 9 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
173914|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 6 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
173915|NCT00094900|Secondary|Mean Change in Swollen Joint Count|Count of swollen joints in patient from baseline to 3 months. 68 swollen joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||swollen joints||Standard Error|Mean
173916|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 24 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
173917|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 20 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
173918|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 16 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
173919|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 12 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
173990|NCT00094809|Secondary|Dose Delay or Reduction Due to Neutropenia|Dose delay or reduction in chemotherapy doses due to neutropenia|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
173920|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 9 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
173921|NCT00094900|Secondary|Mean Change in Tender Joint Count.|Count of tender joints in patient from baseline to 6 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
173922|NCT00094900|Secondary|Mean Change in Tender Joint Count|Count of tender joints in patient from baseline to 3 months. 68 tender joints were assessed manually in a standardized fashion. (Reference: Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727.-35)|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||tender joints||Standard Error|Mean
173923|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173924|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173925|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173926|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173927|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173928|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173929|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Fatigue, by VAS|Patient's assessment of fatigue by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173930|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173931|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173932|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173933|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173934|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173935|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173936|NCT00094900|Secondary|Mean Change in Patient’s Assessment of Pain, by VAS|Patient's global assessment of pain by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173937|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173938|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173939|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173940|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173941|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173942|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173943|NCT00094900|Secondary|Mean Change in Physician’s Global Assessment, by VAS|Physician's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173944|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 24 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|24 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173945|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 20 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|20 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173946|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 16 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|16 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173947|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 12 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|12 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173948|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 9 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|9 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173949|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 6 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|6 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173950|NCT00094900|Secondary|Mean Change in Patient’s Global Assessment, by VAS|Patient's global assessment change by visual analog scale from baseline to 3 months. A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. The VAS had a range of 0–10 cm, with 0 as none and 10 being the worst.|3 months|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173951|NCT00094900|Primary|Response to Treatment (ACR20) in Patients With Adult Onset Still's Disease|At the 24 month post-dose visit, an ACR20 responder was defined as someone who achieved at least 20% improvement in the tender and the swollen 28-joint count, and 20% improvement in at least 3 of the following 5 measures: Patient's pain assessment, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Patient self-assessed disability, Acute phase reactant.|24 months|The analyses included only those subjects with Adult Onset Still's Disease (AOSD)||participants|||Number
173952|NCT00094900|Primary|Mean Change in SAA|SAA change from baseline to 10 days.The serum Amyloid A (SAA) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||mg/liter||Standard Error|Mean
173953|NCT00094900|Primary|Mean Change in hsCRP|hsCRP change from baseline to 10 days.The high sensitivity C-reactive protein (hsCRP) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||mg/dl||Standard Error|Mean
173954|NCT00094900|Primary|Mean Change in ESR|ESR change from baseline to 10 days.The Erythrocyte Sedimentation Rate (ESR) is an acute phase reactant measured to evaluate lab parameters of inflammation|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||mm/hour||Standard Error|Mean
173955|NCT00094900|Primary|Mean Change in Daily Scores|Daily scores change from baseline to 10 days. The clinical daily diary scores (a composite score that included fever, rash, and arthritis/arthralgia, with each of the 3 symptoms scored from 0 [no symptom] to 4 [worst symptom], with an overall range score of 0–12).|10 days for 4 patient, 6 days for 1 patient|The analyses included only those subjects with Familial Cold Autoinflammatory Syndrome (FCAS)||units on a scale||Standard Error|Mean
173956|NCT00094887|Secondary|Rate of Acute Chest Syndrome/Pneumonia Requiring Blood Transfusion||study duration||||||
173957|NCT00094887|Secondary|Length of Hospitalization From Admissions Defined by the Time of the Discharge Order is Written||study duration||||||
173958|NCT00094887|Secondary|Blood Chemistry Levels||every 24 hours for the first 5 days after start of treatment.||||||
173959|NCT00094887|Secondary|Need for Analgesics||baseline and throughout treatment.||||||
173960|NCT00094887|Secondary|Methemoglobin Levels||at 2,4,6, and 8 hours after the start of therapy and then every 24 hours while on therapy.||||||
173961|NCT00094887|Secondary|Vital Signs||At baseline, then every hour for the first 8 hours of therapy, followed by every 4 hours of therapy.||||||
173962|NCT00094887|Primary|Time to Resolution of Vaso-occlusive Pain Crisis (VOC)|"Time to VOC resolution was defined by:~Pain relief - Visual Analog Scale (VAS) pain scores of 6 or less, (6 as worst and 0 as best) Freedom from parenteral narcotic use, Ability to walk unless the subject was not able to walk for any reason other than acute VOC prior to the onset of crisis, Subject and/or family’s belief that the painful crisis could be managed at home with or without oral analgesic use, and the physician concurred with that assessment."|Up to 30 days|75 subjects were assigned to treatment with iNO and 75 subjects were assigned to treatment with placebo; all subjects were included in the ITT and Safety Populations. 142 subjects completed the study according to the protocol and 8 subjects (4 in each treatment group) did not complete the study according to protocol.||Hours||95% Confidence Interval|Median
173963|NCT00094861|Secondary|Maximal Body Weight Loss|Maximal weight loss observed from Baseline through to Week 12.|Baseline through Week 12|Full analysis set with available data||kilograms||Standard Deviation|Mean
173964|NCT00094861|Secondary|Number of Participants Hospitalized||Baseline to Week 16|Full analysis set||participants|||Number
174112|NCT00093782|Secondary|Survival Rate|Computed using the Kaplan-Meier method.|1 year|Out of the 25 patients alive as of Jan 2006||percentage of participants||95% Confidence Interval|Number
173965|NCT00094861|Secondary|Maximal Eastern Cooperative Oncology Group (ECOG) Performance Status Increase|"Maximal increase from Baseline in Eastern Cooperative Oncology Group (ECOG) performance status. ECOG is a scale to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.~Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; Grade 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; Grade 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; Grade 5: Dead."|Baseline through Week 12|Full analysis set participants with available ECOG data||units on a scale||Standard Deviation|Mean
173966|NCT00094861|Secondary|Number of Participants With Unplanned Breaks in Radiotherapy|The number of participants with unplanned breaks in radiotherapy of ≥ 5 days or who discontinued radiotherapy during Week 1 to Week 6.|Week 1 to Week 6|Full analysis set||participants|||Number
173967|NCT00094861|Secondary|Number of Participants With Severe (Grade 3 or Higher) Dysphagia|"Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:~Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set||participants|||Number
173968|NCT00094861|Secondary|Maximal Dysphagia Grade|"The mean maximal grade of dysphagia for each participant during the study. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:~Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set participants with dysphagia assessments.||grade||Standard Deviation|Mean
173969|NCT00094861|Secondary|Duration of Grade 2 or Higher Dysphagia|"Duration of grade 2 or higher dysphagia was calculated in days from the onset (first occurrence of grade ≥ 2) to the resolution (grade ≤ 1 after the last grade ≥ 2) of dysphagia.~Participants with no assessments were assumed as having grade ≥ 2 dysphagia and with a duration of the mean duration of all participants."|Start of treatment through Week 16|Full analysis set||days||Standard Deviation|Mean
173970|NCT00094861|Primary|Number of Participants With Grade 2 or Higher Dysphagia|"Participants underwent acute dysphagia assessments twice weekly during Weeks 1 through 7, and twice weekly thereafter (Weeks 8 through 12) and once weekly after Week 12 until dysphagia resolved to grade ≤ 1 but not beyond Week 16. Dysphagia (difficulty swallowing) was graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale according to the following:~Grade 1: Symptomatic, able to eat regular diet; Grade 2: Symptomatic and altered eating/swallowing (e.g., altered dietary habits, oral supplements), IV fluids indicated <24 hours; Grade 3: Symptomatic and severely altered eating/swallowing (e.g., inadequate oral caloric or fluid intake), IV fluids, tube feedings, or total parenteral nutrition (TPN) indicated ≥24 hours; Grade 4: Life-threatening consequences (e.g., obstruction, perforation)."|Start of treatment through Week 16|Full analysis set||participants|||Number
173971|NCT00094835|Primary|Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 2|The trough plasma concentration for motesanib at 24 hours postdose in Cycle 2. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).|Cycle 2, Day 1, 24 hours post-dose|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for two treatment groups for which the sample size was smaller than 3.||ng/mL||Standard Deviation|Mean
173972|NCT00094835|Primary|Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Motesanib in Cycle 2|Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) for motesanib in Cycle 2 calculated using the using the linear/log trapezoidal method. For the 75 mg BID cohort AUC0-24 is the sum of AUC0-12 for the first and second daily dose.|Cycle 2, Day 1 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for two treatment groups for which the sample size was smaller than 3.||μg*hr/mL||Standard Deviation|Mean
173973|NCT00094835|Primary|Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 2|The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for three treatment groups for which the sample size was smaller than 3.||hours||Standard Deviation|Mean
173974|NCT00094835|Primary|Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 2|The maximal observed plasma concentration of motesanib in Cycle 2, after multiple doses. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population||ng/mL||Standard Deviation|Mean
173975|NCT00094835|Primary|Time to Maximum Plasma Concentration of Motesanib (Tmax) in Cycle 2|The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 2. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.|Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population||hours||Full Range|Median
173976|NCT00094835|Primary|Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 1|The trough plasma concentration for motesanib at 24 hours postdose in Cycle 1. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).|Cycle 1, Day 3, 24 hours post-dose|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.||ng/mL||Standard Deviation|Mean
173977|NCT00094835|Primary|Area Under the Plasma Concentration-time Curve for Motesanib in Cycle 1|Area under the plasma concentration-time curve for motesanib in Cycle 1 calculated using the using the linear/log trapezoidal method. AUC from time zero to infinity (AUC0-inf) is reported for the 50 and 125 mg QD cohorts and AUC from time 0 to 24 hours post-dose (AUC0-24) is reported for the 75 mg BID cohort, where AUC0-24 is the sum of AUC0-12 for the first and second daily dose.|Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.||μg*hr/mL||Standard Deviation|Mean
173978|NCT00094835|Primary|Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 1|The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours postdose.|PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.||hours||Standard Deviation|Mean
173979|NCT00094835|Primary|Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 1|The maximal observed plasma concentration of motesanib after a single dose dose in Cycle 1. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|PK population||ng/mL||Standard Deviation|Mean
173980|NCT00094835|Secondary|Percentage of Participants With an Overall Objective Response|Confirmed objective tumor response defined as a complete response (CR) or partial response (PR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Tumor response was evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI). Responding disease (CR or PR) was confirmed no less than 4 weeks after the criteria for response were first met. A complete response defined as the disappearance of all target lesions and all non-target lesions, no new lesions and normalization of tumor marker level. Partial response defined as either the disappearance of all target lesions and the persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diamer (LD) of target lesions, taking as reference the baseline sum LD and no new lesions and/or unequivocal progression of existing non-target lesions.|After 9 weeks of treatment (at the end of Cycle 3)|Efficacy analysis set, composed of all enrolled participants who received at least one dose of motesanib in treatment arms 1-3 or at least one dose of motesanib with one dose of panitumumab in treatmnt arms 4-7.||Percentage of participants|||Number
173981|NCT00094835|Primary|Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1|The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 1. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.|Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.|The pharmacokinetic (PK) population consisted of all consented patients who received motesanib and had evaluable pharmacokinetic data and did not have significant protocol deviations that affected the data or key-dosing information that was missing.||hours||Full Range|Median
173982|NCT00094809|Primary|Grade 4 Neutropenia|Grade 4 neutropenia, defined as an absolute neutrophil count (ANC) <0.5 x 10^9/L, in any of the first four cycles of treatment|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
173983|NCT00094809|Secondary|Antibiotic Use Due to Febrile Neutropenia|Antibiotic use during any of the first 4 cycles of treatment due to febrile neutropenia.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
173984|NCT00094809|Secondary|Survival|Death from any cause through the end of the follow-up period|Up to 24 months after first four cycles of treatment|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures.||Participants|||Number
173985|NCT00094809|Secondary|Objective Tumor Response|Objective tumor response (complete or partial) at the end of treatment, defined as a reduction of at least 50% in the area of all measurable lesions (partial response) or disappearance of all measurable or evaluable disease without the development of new lesions (complete response) on computed tomographic (CT) or other scanning.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
173986|NCT00094809|Secondary|Progression-Free Survival|Kaplan-Meier estimate of the median time to disease progression or death|Up to 24 months after first four cycles of treatment|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Days||95% Confidence Interval|Median
173987|NCT00094809|Secondary|Hospitalization Due to a Neutropenia-Related Event|Hospitalization because of a neutropenia-related event during the first 4 cycles of treatment|First 4 cycles of neutropenia (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
173988|NCT00094809|Secondary|Febrile Neutropenia|Febrile neutropenia, Defined as a temperature ≥ 38.2 °C on a given day, with an ANC < 1.0 x 10^9/L recorded on the same day or the next day, during any of the first 4 cycles of treatment.|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
173991|NCT00094809|Primary|Grade 3 or 4 Neutropenia|Grade 3 or 4 neutropenia, defined as an absolute neutrophil count (ANC) < 1 x 10^9/L, in any of the first four cycles of treatment|First 4 cycles of treatment (8 weeks)|Primary Analysis Set, composed of all participants who received study drug and who signed an informed consent before any invasive procedures||Participants|||Number
173992|NCT00094770|Secondary|Number of Participants With Drug-related LAEs at Week 104|Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
173993|NCT00094770|Secondary|Number of Participants With Serious LAEs at Week 104|Serious LAEs are any LAEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
173994|NCT00094770|Secondary|Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 104|A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
173995|NCT00094770|Secondary|Number of Participants With Drug-related CAEs at Week 104|Participants with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
173996|NCT00094770|Secondary|Number of Participants With Serious CAEs at Week 104|Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
173997|NCT00094770|Secondary|Number of Participants With Clinical Adverse Experiences (CAEs) at Week 104|An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
173998|NCT00094770|Secondary|Hypoglycemic Events at Week 104|Number of participants who reported 1 or more episodes of the adverse experience of hypoglycemia.|Baseline to Week 104|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
173999|NCT00094770|Secondary|Hypoglycemic Events at Week 52|Number of participants who reported 1 or more episodes of the adverse experience (AEs) of hypoglycemia.|Baseline to Week 52|All randomized participants who received at least 1 dose of the double-blind study therapy.||Participants|||Number
174000|NCT00094770|Secondary|Change From Baseline in Body Weight at Week 104|Change from baseline at Week 104 is defined as Week 104 minus Week 0.|Baseline and Week 104|The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed.||Kilograms||95% Confidence Interval|Least Squares Mean
174001|NCT00094770|Secondary|Change From Baseline in Body Weight at Week 52|Change from baseline at Week 52 is defined as Week 52 minus Week 0.|Baseline and Week 52|The All-Patient-as-Treated (APaT) population required that a participant received at least 1 dose of double-blind study therapy. No missing data were imputed.||Kilograms||95% Confidence Interval|Least Squares Mean
174002|NCT00094770|Secondary|Change From Baseline in HbA1c at Week 104|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 104|The per protocol population required that a participant had measurements both at baseline and at Week 104, and did not have any major protocol violations (e.g. drug compliance < 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.||Percent||95% Confidence Interval|Least Squares Mean
174003|NCT00094770|Primary|Change From Baseline in HbA1c at Week 52|HbA1c is measured as percent. Thus, this change from baseline reflects the Week 52 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and Week 52|The per protocol population required that a participant had measurements both at baseline and at Week 52, and did not have any major protocol violations (e.g. drug compliance < 75%, addition of prohibited antihyperglycemic agent, incorrect double-blind study medication). No missing data were imputed.||Percent||95% Confidence Interval|Least Squares Mean
174004|NCT00094757|Secondary|Change From Baseline in FPG at Week 54|The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.|Weeks 0-54|All Patients Treated included patients who received at least 1 dose of study therapy 1 post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.||mg/dL||95% Confidence Interval|Least Squares Mean
174005|NCT00094757|Secondary|Change From Baseline in A1C at Week 54|A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.|Weeks 0-54|All Patients Treated included patients who received at least 1 dose of study therapy post-Week 18, a baseline value and ≥1 post-Week 18 value for this outcome. The last post- Week 18 observed measurement was carried forward to Week 54 for patients with no data at Week 54. Data after initiation of glycemic rescue were considered missing.||percent||95% Confidence Interval|Least Squares Mean
174006|NCT00094757|Secondary|Change From Baseline in FPG at Week 18|The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.|Weeks 0-18|All Patients Treated included patients who received at least 1 dose of study therapy, and had a baseline value and ≥1 post-baseline value for this outcome. The last post-baseline observed measurement was carried forward to Week 18 for patients with no data at Week 18. Data after initiation of glycemic rescue were considered missing.||mg/dL||95% Confidence Interval|Least Squares Mean
174113|NCT00093782|Secondary|Median Survival Time|Computed using the Kaplan-Meier method.|3|Out of the 25 patients alive (in 2006 at time of publication)||months||95% Confidence Interval|Median
174007|NCT00094757|Primary|Change From Baseline in A1C at Week 18|Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.|Weeks 0-18|All Patients Treated included those with ≥1 dose of study therapy, had a baseline and ≥1 post-baseline value. For those with no data at Week 18, last post-baseline observation was carried forward. Data after initiation of glycemic rescue were considered missing. Analysis adjusted for baseline values and prior antihyperglycemic therapy status.||percent||95% Confidence Interval|Least Squares Mean
174008|NCT00094653|Secondary|Clinically Meaningful Changes in Vital Signs and Physical Examinations|Clinically meaningful changes were according to investigator. Vital sign measurements include height, weight, temperature, pulse, and resting systolic and diastolic blood pressure.|vital signs and physical examination were evaluated at screening and at Weeks 1, 4, 7, 10, 12, 16, 20, 24, 28, 36, and every 3 months thereafter|All subjects who received at least 1 dose or any partial dose of study medication.||participants|||Number
174009|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Renal Abnormalities|CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.||percentage of participants|||Number
174010|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Liver Abnormalities|ALT=alanine aminotransferase; AST=aspartate aminotransferase. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.||percentage of participants|||Number
174011|NCT00094653|Secondary|Percentage of Participants With Worst On-Study Hematological Abnormalities|ANC=Absolute Neutrophil Count. CTCAE v3.0 Grades 0 through 4 of severity for each AE based on this general guideline: Grade 0=Normal, Grade 1=Mild AE, Grade 2=Moderate AE, Grade 3=Severe AE, Grade 4=Life-threatening or disabling AE.|On-study laboratory results are results reported after the first dose date and within 70 days of last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication. N=Number of participants analyzed; n=number of participants with given laboratory evaluation.||percentage of participants|||Number
174012|NCT00094653|Secondary|Percentage of Participants With Immune-Related Adverse Events (irAEs)|"An immune related adverse event (irAE) was defined as an adverse event of unknown etiology, associated with study drug exposure and consistent with an immune phenomenon. The irAEs were programmatically determined from a predefined list of MedDRA version 12.0 high-level group terms, high-level terms and preferred terms of all ipilimumab related adverse event. The category of Other irAEs includes blood, eye, immune, infections, renal, and respiratory systems."|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication.||percentage of participants|||Number
174013|NCT00094653|Secondary|Percentage of Participants With On-Study Adverse Events (AEs) and AEs With an Outcome of Death|An AE was defined as any undesirable sign, symptom, clinically significant laboratory abnormality, or medical condition occurring after starting study treatment, even if the event was not considered to be treatment-related. Adverse events are graded using the Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. If CTCAE grading does not exist for an adverse event, the intensity of mild (1), moderate (2), severe (3), and life-threatening (4) were used.|On-study adverse events include all AEs reported between the first dose and 70 days after the last dose of study therapy (end of the study was defined as the time at which 481 deaths were observed [264 weeks]).|All subjects who received at least 1 dose or any partial dose of study medication.||percentage of participants|||Number
174014|NCT00094653|Secondary|Change From Baseline in Health-Related Quality of Life (QOL) as Measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Instrument at Week 12|The 30 items were grouped into the following: 1 global QOL scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). All scores were linearly transformed to a 0 to 100 scale. For global QOL and functional items, a higher score represents a better level of functioning (100=best/0=worst). For symptom items, a higher score represents a higher level of symptoms (0=no symptom at all/100=very much severe).|Baseline (Day 1, Cycle1), Week 12|All subjects who received at least 1 dose or any partial dose of study medication. N=number of participants analyzed, n=number of participants with measure at given time points.||units on a scale||95% Confidence Interval|Least Squares Mean
174015|NCT00094653|Secondary|Delayed Response (Response Beyond Week 24)|Response was based on the investigators' assessment using modified World Health Organization (WHO) criteria. Delayed response is defined as post Week 24 overall response for the subjects who have PD before or at Week 24. Evaluation of delayed overall response is compared to baseline assessment. Delayed response includes delayed late CR, delayed late PR, delayed late SD, continued PD, unknown, and missing after Week 24. The delayed response of CR and PR also must have been confirmed.|from Week 24 to end of study (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Number of subjects with BOR of PR/SD (80 subjects ipi + gp100 , 37 ipi , 15 gp100) plus number of subjects with BOR of PD that had subsequent evaluation (8 ipi + gp100, 3 ipi, 3 gp100).||participants|||Number
174016|NCT00094653|Secondary|Disease Control Rate (DCR)|Response was based on the investigators' assessment using modified WHO criteria. DCR is defined as the number of subjects whose BOR is CR, PR, or SD divided by the total number of subjects in the group.|Up to week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||percentage of participants||95% Confidence Interval|Number
174017|NCT00094653|Secondary|Duration of Response|Kaplan-Meier medians along with Brookmeyer and Crowley 95% confidence intervals (CI) for were computed. Duration of response was defined in subjects whose BOR was CR or PR as the number of days between the date of response (CR or PR) and the date of PD or the date of death (whichever occurs first).|from time of initial drug administration to date of PD or death due to PD (the end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Responders only in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Patients who did not progress or died were censored at the date of their last tumor assessment.||months||95% Confidence Interval|Median
174018|NCT00094653|Secondary|Time to Response|Time to response was defined as the number of days from the date of randomization to the date when measurement criteria are met for BOR of CR or PR, as determined by investigator.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Responder subjects in intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||months||Full Range|Mean
174019|NCT00094653|Secondary|Determination of Best Overall Response Rate (BORR)|Response was based on the investigators’ assessment using modified WHO criteria. BORR is defined as the number of subjects whose BOR is complete or partial response (CR or PR) divided by the total number of subjects in the group. BORR was comprised of responder and non-responder. The definition of a responder in BORR was either confirmed CR or PR, and a non-responder was defined as stable disease (SD), progressed disease (PD), unconfirmed CR (uCR), unconfirmed PR (uPR), and not evaluated.|Up to week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||percentage of participants||95% Confidence Interval|Number
174020|NCT00094653|Secondary|Best Overall Response (BOR): Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressed Disease (PD)|Investigator’s assessment, modified World Health Organization criteria. CR: disappearance of all lesions by 2 consecutive observations >=4 weeks apart, no evidence of PD. PR: >=50% ↓ in sum of products of longest diameter & greatest perpendicular diameter of all target lesions compared to baseline by 2 observations >=4 weeks apart. SD: Neither sufficient ↓ to qualify for PR nor sufficient ↑ to qualify for PD. PD: ↑ >=25% in sum of products of longest diameter & greatest perpendicular diameter of target lesions compared to smallest recorded sum during study, or appearance of >= 1 new lesion.|BOR was determined between Weeks 12 and Week 24 confirmation at least 4 weeks later at Cycle 1.|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||participants|||Number
174021|NCT00094653|Secondary|Time to Progression (TTP)|TTP was defined as the number of days between the date of the randomization and date of PD or death due to PD. For subjects who had not progression and remained alive, TTP was censored on the date of last assessment; those who remained alive and had no recorded post-baseline assessment, TTP was censored on the date of randomization; those who remained alive and had randomized but were not treated, TTP was censored at the date of randomization; for those who died without reported disease progression, TTP was censored on the date of death.|from time of randomization to date of PD or death due to PD (end of the study was defined as the time at which 481 deaths were observed [264 weeks])|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||months||95% Confidence Interval|Median
174022|NCT00094653|Secondary|Percentage of Participants With Progression Free Survival (PFS) at Week 12 and Week 24|PFS at Week 12 was defined as the probability that the subject was progression-free at 12 weeks and 24 weeks following the start of randomization. It was computed via Kaplan-Meier method, truncated at Week 12 and Week 24. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|Week 12, Week 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||percentage of participants||95% Confidence Interval|Median
174023|NCT00094653|Secondary|Progression Free Survival (PFS)|PFS was defined as the number of days between the date of randomization and the date of the progression or the date of death. A subject who died without prior progression was considered to have progressed on the date of death. PFS was determined by investigator. 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study. Subjects who neither progressed nor died were censored at the date of the last tumor assessment.||months||95% Confidence Interval|Median
174024|NCT00094653|Secondary|12-, 18-, and 24-Month Survival Rates|The probability that a subject is alive at 12 months, 18 months, and 24 months following randomization, estimated via the non-parametric method (Kaplan-Meier method). For calculating 95% CI, bootstrap method was used with 20000 simulated trials.|Month 12, Month 18, Month 24|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||probability||95% Confidence Interval|Number
174025|NCT00094653|Secondary|Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 Monotherapy Versus gp100 Melanoma Peptide Vaccine Alone and MDX-010 in Combination With gp100 Melanoma Peptide Vaccine Versus MDX-010 Monotherapy|OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||months||95% Confidence Interval|Median
174026|NCT00094653|Primary|Overall Survival (OS) (Time-to-Death) Difference Between MDX-010 in Combination With gp 100 Melanoma Peptide Vaccine Versus gp 100 Melanoma Peptide Vaccine Alone|OS was defined as the time from randomization until death from any cause. If a participant did not expire, the subject was censored at the time of last contact (last known alive date). 95% confidence intervals (CI) for median were computed using Brookmeyer and Crowley method.|From randomization until the end of the study, which was defined as the time at which 481 deaths were observed (264 weeks)|Intent-to-treat population, as randomized. All subjects who were randomized to any treatment group in the study.||months||95% Confidence Interval|Median
174366|NCT00090584|Secondary|Change in Voids Per Day|Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary|baseline and 10 weeks|All women with valid bladder diary at baseline and 10 weeks in each treatment group.||voids per day||Standard Error|Mean
174027|NCT00094575|Secondary|International Index of Erectile Function (IIEF-5)|"Change (over time) since baseline in IIEF-5. The IIEF-5 Score ranges from 5-25 with higher scores indicating better erectile function.~Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
174028|NCT00094575|Secondary|European Quality of Life-5 Dimension (EQ-5D) Visual Analog Scale|"Change (over time) since baseline in EQ-5D Visual Analog Scale. The EQ-5D Visual Analog Scale ranges from 0 (death) to 1 (perfect health). Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
174029|NCT00094575|Secondary|European Quality of Life-5 Dimension (EQ-5D) Index Score|"Change (over time) since baseline in EQ-5D. The EQ-5D Index Score ('thermometer scale') ranges from 0 (worst health status) to 100 (best health status). Since this outcome captures change since baseline, values could be below 0.~Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
174030|NCT00094575|Secondary|SF-36 Physical Component Deaths Included Score (PCTD)|"Change (over time) since baseline in Physical Component Deaths included Score of SF-36.~The PCTD Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
174031|NCT00094575|Secondary|SF-36 Physical Component Score (PCS)|"Change (over time) since baseline in Physical Component Score of SF-36. The PCS Score ranges from 0-100 with higher scores indicating better health Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and yearly thereafter, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
174032|NCT00094575|Secondary|SF-36 Mental Component Score (MCS)|"Change (over time) since baseline in Mental Component Score of SF-36. The MCS Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.~Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points."|Outcome was assessed at 6 months and then yearly, up to 9 years|||units on a scale||95% Confidence Interval|Least Squares Mean
174033|NCT00094575|Secondary|Secondary Therapeutic Procedures|This outcome includes any procedure that resulted directly or indirectly from the initial procedure and that required a separate trip to the procedure suite (with each trip to the procedure suite counting as one secondary procedure), including any unplanned surgical procedures within 30 days after the initial procedure and any additional aortoiliac procedures at any time.|Participants were followed for the duration of the study, up to 9 years|||participants|||Number
174034|NCT00094575|Primary|All-cause Mortality|Participants vital status was assessed from randomization to end of study follow-up [10/15/2011] or death [whichever occurred first].|Participants were followed for the duration of the study, up to 9 years|||participants|||Number
174035|NCT00094497|Other Pre-specified|Impact of Reaching Mitotane Blood Levels Between 14-20 mg/l in Both Arms on Survival and Overall Response Rate||every 8 weeks until progression or until Dec 2010||||||
174036|NCT00094497|Other Pre-specified|Pharmakinetics of Mitotane (Substudy)|To study the relationship between mitotane dose (daily and cumulative) and mitotane plasma concentrations using one of two pre-defined treatment regimens (high-dose and low-dose).|11 time points in the first 12 weeks||||||
174037|NCT00094497|Other Pre-specified|TTP of Both Regimens as Second Line Treatment in Case of Failure of the Other Initial Regime||every 8 weeks until progression or until Dec 2010||||||
174038|NCT00094497|Secondary|Number of Disease-free Patients|complete response or disease-free by time of surgery|every 8 weeks until progression (up to 5 years)|||participants|||Number
174039|NCT00094497|Secondary|Best Overall Response Rate|RECIST 1.0 was used to evaluate response|every 8 weeks up to 5 years|||participants|||Number
174040|NCT00094497|Secondary|Change in Quality of Life as Measured by QLQ-C30|scale ranged from 0 to 100 with higher score meaning greater quality of life|baseline and 8 weeks|participants with data on both time points||units on a scale||Standard Deviation|Mean
174041|NCT00094497|Secondary|Progression-free Survival||every 8 weeks until progression or death up to 5 years|||months||95% Confidence Interval|Median
174042|NCT00094497|Primary|Overall Survival|participants who died among those randomized to first-line therapy|every 8 weeks until death up to 5 years|||participants|||Number
174043|NCT00094458|Secondary|Average Corticosteroid Use|Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)|Weeks 2, 6, 10, 18 and 26|Population analyzed included all randomized participants taking corticosteroids for Crohn’s disease. n' signifies number of participants who were evaluable at specified time point, for each arm respectively.||milligram per day||Standard Deviation|Mean
174044|NCT00094458|Secondary|Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study)|Quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32- item questionnaire and the total IBDQ score can range from 32 (very poor) to 224 (perfect).|Baseline and Weeks 2, 6, 10, 18, 26|Population analyzed included all randomized participants enrolled in Main Study with last observation carried forward method to impute missing data. 'n' signifies number of participants who were evaluable at specified time point, for each arm respectively.||units on a scale||Standard Deviation|Mean
174045|NCT00094458|Secondary|Percentage of Participants With Clinical Response Over Time (Study Extension)|Clinical response, defined as a >=100-point decrease in CDAI from Baseline.|Weeks 34, 42, 50|Population analyzed included all randomized participants during the Study Extension.||percentage of participants|||Number
174046|NCT00094458|Secondary|Percentage of Participants With Clinical Response Over Time (Main Study)|Clinical response, defined as a >=100-point decrease in CDAI from Baseline.|Weeks 2, 6, 10, 18, 26|Population analyzed included all randomized participants during the Main Study.||percentage of participants|||Number
174047|NCT00094458|Secondary|Percentage of Participants With Clinical Remission (Study Extension)|Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)|Weeks 34, 42 and 50|Population analyzed included all randomized participants enrolled in the Study Extension.||percentage of participants|||Number
174048|NCT00094458|Secondary|Percentage of Participants With Clinical Remission (Main Study)|Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)|Weeks 2, 6, 10, 18 and 26|Population analyzed included all randomized participants enrolled in the main study.||percentage of participants|||Number
174049|NCT00094458|Secondary|Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension)|Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) < 150 who have not received any dose of systemic corticosteroids (prednisone or equivalent) for >= 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).|Week 50|Population analyzed included all randomized participants enrolled in Study Extension.||percentage of participants|||Number
174050|NCT00094458|Secondary|Percentage of Participants With Mucosal Healing|Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.|Week 26|Analysis population for mucosal healing was per protocol. All subjects with lesions at Baseline (Week 0) and an Endoscopy at Week 26 were included in the analysis. Here, ‘N’ [number of participants analyzed] signifies those participants who were evaluable for this measure.||percentage of participants|||Number
174051|NCT00094458|Primary|Percentage of Participants With Corticosteriod-free Clinical Remission|Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than (<) 150 in participants who have not received any dose of systemic corticosteroids (prednisone or equivalent) for greater than or equal to (>=) 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).|Week 26|Intention to treat (ITT) population includes all randomized participants in the analysis, according to the treatment group to which they were randomized, regardless of the treatment they actually received.||percentage of participants|||Number
174052|NCT00094328|Secondary|Change in Predicted Adult Height (PAH)|Radiographs will be used to assess the bone age, the PAH is calculated from the bone age using the Bayley and Pinneau Method. The change in PAH will be calculated by subtracting the PAH at baseline from the PAH at 12 months.|Assessed after 12 months treatment|Calculated on All treated analysis set, however, if bone age is less than 6 years or bone age is less than 7 years and bone age>=(chronological age-1) then PAH cannot be calculated using the Bayley and Pinneau method.||cm||Standard Deviation|Mean
174053|NCT00094328|Secondary|Normalization of Growth Rate|The number of patients whose height lies between the 5th and 95th percentiles (using the percentile tables on the WHO database) for chronological age at the 12 month assessment.|Assessed after 12 months treatment|||Participants|||Number
174054|NCT00094328|Secondary|Change in Bone Maturation Rate|Radiographs were used to assess the bone age at ≥6 months pre-study, baseline, 6 months and 12 months. The rate of change in bone age at baseline was calculated from a radiograph taken at least 6 months prior to study enrolment. The change in bone maturation was calculated from this rate and that calculated at 12 months.|Assessed after 12 months treatment|Calculated on All treated analysis set for those patients who had a 6-month pre study radiograph.||cm/year||Standard Deviation|Mean
174055|NCT00094328|Primary|Change in Growth Rate (SD Units)|Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation [SD] score).|Assessed after 12 months treatment|||SD units||Standard Deviation|Mean
174056|NCT00094328|Primary|Change in Growth Rate (cm/Year)|Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year).|Assessed after 12 months treatment|||cm/year||Standard Deviation|Mean
174057|NCT00094302|Secondary|Estimated Glomerular Filtration Rate (GFR)|Average post-baseline GFR, taking into consideration baseline GFR, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||mL/min/1.73m2||Standard Error|Least Squares Mean
174114|NCT00093782|Secondary|Stable Disease Rate Defined by RECIST Criteria|Potential association between variables will be measured using Pearson correlation coefficients, chi-square tests, one- or two-sample t-tests or logistic regression analyses as appropriate. Ninety-five percent confidence intervals will be constructed and selected results will be illustrated using figures and plots.|Up to 8 years|||participants|||Number
174058|NCT00094302|Secondary|Chloride|Average post-baseline Chloride, taking into consideration baseline Chloride, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||mEq/L||Standard Error|Least Squares Mean
174059|NCT00094302|Secondary|Sodium|Average post-baseline Sodium, taking into consideration baseline Sodium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||mEq/L||Standard Error|Least Squares Mean
174060|NCT00094302|Secondary|Serum Creatinine|Average post-baseline serum creatinine, taking into consideration baseline serum creatinine, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||mg/dL||Standard Error|Least Squares Mean
174061|NCT00094302|Secondary|Potassium|Average post-baseline Potassium, taking into consideration baseline Potassium, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||mEq/L||Standard Error|Least Squares Mean
174062|NCT00094302|Secondary|Hospitalization for Any Reason|First incidence of a hospitalization for any reason|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174063|NCT00094302|Secondary|Depression Symptoms, as Measured by Patient Health Questionnaire.|"Average post-baseline depression, taking into consideration baseline depression, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Patient Health Questionnaire (PHQ) is a 10-item, self-administered instrument for screening, diagnosing, monitoring and measuring the severity of depression. Scores can range from 0-27, in which lower scores reflect better mental health status. The PH-Q was administered at the following study visits: baseline, month 12 and annually thereafter. Valid translations of this questionnaire were only available for subjects enrolled in the United States and Canada."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants from the United States and Canada who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||units on a scale||Standard Error|Least Squares Mean
174064|NCT00094302|Secondary|Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.|"Average post-baseline quality of life, taking into consideration baseline quality of life and treatment group.~The McMaster Overall Treatment Evaluation questionnaire is a self-administered 3-item instrument that measures a patient's perception of change in their health-related quality of life since the start of therapy. The questionnaire consists of a single question - Since treatment started, has there been any change in your activity limitation, symptoms and/or feelings related to your heart condition? Scores can range from -7 to +7, and higher scores reflect better health status. The questionnaire was administered at the following study visits: month 4 and month 12. Valid translations of this questionnaire were only available for subjects enrolled in the United States, Canada and Argentina."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants from United States, Canada and Argentina who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||units on a scale||Standard Error|Least Squares Mean
174065|NCT00094302|Secondary|Quality of Life, as Measured by the EuroQOL Visual Analog Scale.|"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The EuroQOL visual analog scale (EQ5D) is a single-item, self-administered instrument that quantifies current health status. Scores can range from 0-100, in which higher scores reflect better health status. The EQ5D was administered at the following study visits: baseline, month 4, month 12 and annually thereafter."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||units on a scale||Standard Error|Least Squares Mean
174066|NCT00094302|Secondary|Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.|"Average post-baseline quality of life, taking into consideration baseline quality of life, treatment group, the time between the post-baseline measures, and the correlation between repeated measures within an individual.~The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The KCCQ was administered at the following study visits: baseline, month 4, month 12 and annually thereafter."|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||units on a scale||Standard Error|Least Squares Mean
174067|NCT00094302|Secondary|Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174068|NCT00094302|Secondary|Deterioration of Renal Function|First incidence of a deterioration of renal function. The TOPCAT protocol defines deterioration of renal function as occurring if a subject has a serum creatinine value which is at least double the baseline value for that subject, and is also above the upper limit of normal (assumed to be 1.0 mg/dL for females and 1.2 mg/dL for males.)|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174069|NCT00094302|Secondary|Stroke|First incidence of stroke|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174070|NCT00094302|Secondary|Myocardial Infarction|First incidence of myocardial infarction|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174071|NCT00094302|Secondary|Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.|First incidence of atrial fibrillation among subjects without a history of atrial fibrillation at baseline|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized and did not have a history of atrial fibrillation at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174072|NCT00094302|Secondary|New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.|First incidence of new onset diabetes mellitus among subjects without a history of diabetes mellitus at baseline.|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized and did not have a history of diabetes mellitus at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174073|NCT00094302|Secondary|Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174074|NCT00094302|Secondary|Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174075|NCT00094302|Secondary|Cardiovascular-related Hospitalization|Hospitalization for MI, stroke or the management of heart failure, whichever occurred first|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174076|NCT00094302|Secondary|Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174077|NCT00094302|Secondary|All-cause Mortality||Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174078|NCT00094302|Secondary|Hospitalization for the Management of Heart Failure|First incidence of a hospitalization for the management of heart failure|Randomization through each subject’s last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174079|NCT00094302|Secondary|Aborted Cardiac Arrest|First incidence of aborted cardiac arrest|Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174080|NCT00094302|Secondary|Cardiovascular Mortality||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174081|NCT00094302|Primary|Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First||Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.|All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.||Events per 100 person-years|||Number
174082|NCT00094172|Secondary|Proportion of Participants Diagnosed With Multiple Sclerosis According to the McDonald Criteria|"Number of participants diagnosed with Multiple Sclerosis (MS) according to the McDonald criteria[1]~The McDonald criteria uses dissemination in time and space[2] established by Magnetic Resonance Image (MRI) findings to provide a clinical diagnosis for MS~Dissemination in time is established by a new T2 or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. The presence of any 3 of the following establishes dissemination in space: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; ≥1 infratentorial lesion; ≥1 juxtacortical lesion; ≥3 periventricular lesions"|18 months post-randomization|Intent-to-Treat||Participants|||Number
174083|NCT00094172|Secondary|Proportion of Participants Who Are Diagnosed With Multiple Sclerosis According to the McDonald Criteria|"Number of participants diagnosed with Multiple Sclerosis (MS) according to the McDonald criteria[1]~The McDonald criteria uses dissemination in time and space[2] established by Magnetic Resonance Image (MRI) findings to provide a clinical diagnosis for MS~Dissemination in time is established by a new T2 or gadolinium-enhancing (Gd+) lesion found on a repeat MRI. The presence of any 3 of the following establishes dissemination in space: 1 Gd+ lesion or 9 T2 bright lesions if there is no enhancement; ≥1 infratentorial lesion; ≥1 juxtacortical lesion; ≥3 periventricular lesions"|12 months post-randomization|Intent-to-Treat||Participants|||Number
174084|NCT00094172|Primary|The Occurrence of ≥ 3 New T2 Lesions With or Without Gd+ Enhancement or Clinical Exacerbation Through 12 Months.|"The occurrence of ≥ T2 lesions[1] with or without gadolinium lesion (Gd+) enhancement[2] or clinical exacerbation[3] through 12 months. A higher score indicates more severe disease~A new T2 lesion is an abnormal, hyperintense white-matter area visible on T2 weighted images that were not present on the baseline scan~A Gd+ enhancement is defined as a contrast enhancement visible on a new T2 lesion~A clinical exacerbation is a new neurological symptom that lasts more than 48 hours in a participant who has been neurologically stable for 30 days following start of study medication"|12 months post-randomization|Intent-to-Treat||Participants|||Number
174085|NCT00094107|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 147 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.||Ratio||Standard Deviation|Mean
174086|NCT00094107|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 147 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.||ng/mL||Standard Deviation|Mean
174087|NCT00094107|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
174088|NCT00094107|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 147 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
174089|NCT00094107|Secondary|Progression-free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 147 weeks|Study population included all participants who received at least 1 dose of study medication and had at least one baseline efficacy assessment.||Days||95% Confidence Interval|Median
174115|NCT00093782|Primary|Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria)|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.|Up to 8 years|||participants|||Number
174116|NCT00093756|Secondary|Frequency and Severity of Observed Toxicity, Graded by Common Terminology Criteria for Adverse Events (CTCAE)||Up to 5 years||||||
174090|NCT00094107|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 147 weeks|Study population included all participants who received at least 1 dose of study medication and had at least one baseline efficacy assessment.||Percentage of participants||95% Confidence Interval|Number
174091|NCT00094094|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 98 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.||Ratio||Standard Deviation|Mean
174092|NCT00094094|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 98 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
174093|NCT00094094|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who enrolled and received treatment.||Days||95% Confidence Interval|Median
174094|NCT00094094|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
174095|NCT00094094|Secondary|Progression-Free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 98 weeks|Study population included all participants who enrolled and received treatment.||Days||95% Confidence Interval|Median
174096|NCT00094094|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks|Study population included all participants who enrolled and received treatment.||Percentage of participants||95% Confidence Interval|Number
174097|NCT00094055|Other Pre-specified|Plasma Concentrations of Soluble Proteins|Plasma concentrations of soluble proteins (vascular endothelial growth factor [VEGF], placental growth factor [PlGF] and soluble vascular endothelial growth factor receptor-2 [sVEGFR2]) may be associated with tumor angiogenesis or tumor physiology and may correlate with efficacy or biological activity. It is presented as ratio to baseline, which is obtained by dividing the plasma soluble protein concentration at each time point by its concentration at baseline.|Day 1 (pre-dose) and then every 8 weeks up to 206 weeks|Ratio to baseline values for plasma soluble proteins were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib Phase 2 studies would be pooled together in a separate report.||Ratio||Standard Deviation|Mean
174117|NCT00093756|Secondary|Survival Time|The distribution of survival time will be estimated using the method of Kaplan-Meier.|From registration to death due to any cause, up to 5 years||||||
174118|NCT00093756|Secondary|Progression-free Survival|The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.|From study registration to the first of either death due to any cause or progression, up to 5 years||||||
174119|NCT00093756|Secondary|Time to Progression|The distribution of time to progression will be estimated > using the method of Kaplan-Meier.|From study registration to date of disease progression or date of last follow-up, up to 5 years||||||
174098|NCT00094055|Other Pre-specified|Population Pharmacokinetics for Axitinib (AG-013736) Plasma Concentrations|Population pharmacokinetic analysis involved mixed effects modeling using nonlinear mixed effects modeling (NONMEM) software. The intent of this analysis was to establish a basic population pharmacokinetic model for axitinib (AG-013736) and to determine inter-individual and residual variability in population (oral) clearance, and volume of distribution of drug. Relationship of demographic variables (gender, age, body weight, height and ethnicity), concomitant medications and measures of altered hepatic and renal function were examined by fitting measured axitinib (AG-013736) concentrations.|Day 1 (pre-dose), Day 29, Day 57 and then every 8 weeks up to 206 weeks|Population pharmacokinetic values were not summarized as descriptive statistics since the data was not available for the single study and data for all the axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.||nanogram/milliliter (ng/mL)||Standard Deviation|Mean
174099|NCT00094055|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as the death date minus the date of first dose of study medication plus 1. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|ITT population included all participants who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
174100|NCT00094055|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 206 weeks|Subgroup of participants from the ITT population with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
174101|NCT00094055|Secondary|Progression-Free Survival (PFS)|"Time in days from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was Death)."|Baseline to disease progression or death due to any cause, assessed every 8 weeks up to 206 weeks|ITT population included all participants who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
174102|NCT00094055|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 206 weeks|Intent to treat (ITT) population included all participants who received at least 1 dose of study medication.||Percentage of participants||95% Confidence Interval|Number
174103|NCT00093847|Secondary|HDRS17 Responders|35.8% versus 11.7%. Response is defined as a 50 percent or more score reduction on on Hamilton Depression Rating Scale 17 item .|Measured at Week 6|ITT LOCF||Percentage of Responders HDRS17|||Number
174104|NCT00093847|Primary|Hamilton Depression Rating Scale Remission Rates|The proportion of remitters for SAMe versus placebo was 46.1% versus 17.6%. Remission is defined as a final score of 7 or less on Hamilton Depression Rating Scale 17 item .|Measured at Week 6|ITT LOCF||Percentage of Remitters HDRS17|||Number
174105|NCT00093808|Secondary|Overall Survival as Assessed by Time|Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method.|Up to 5 years|||months||95% Confidence Interval|Median
174106|NCT00093808|Secondary|Duration of Response as Measured by RECIST Criteria|Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient’s objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented.|Up to 5 years|||months||95% Confidence Interval|Median
174107|NCT00093808|Secondary|Time to Progression (TTP)|Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for any evaluations, that patient will be censored for progression of disease at day one post-registration. Otherwise, for patients that do not progress, censoring will occur at the last follow up date.|Up to 5 years|||months||95% Confidence Interval|Median
174108|NCT00093808|Primary|Confirmed Response Rate|"The primary efficacy endpoint is the overall response rate as determined by the RECIST criteria. A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response.~The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total number of evaluable patients. A 95% confidence interval for the true confirmed response rate will be calculated using the properties of the binomial distribution."|Up to 5 years|||proportion of patients||95% Confidence Interval|Number
174109|NCT00093782|Secondary|Time to Progression||Up to 8 years|At the time of publication, 5 patients were still on treatment and analysis was done on 31 patients||months||95% Confidence Interval|Median
174110|NCT00093782|Secondary|Number of Temsirolimus Treatment Cycle Analyzed for Toxicity|Safety and tolerability of treatment with Temsirolimus assessed using CTCAE v 3|Duration of participants treatment upto 16wks (4cycles) of treatment|||treatment cycles|||Number
174111|NCT00093782|Secondary|Response and Stable Disease|Assessed using RECIST criteria.Patients that had Stable disease for 2 months|2 months|Number of patients that had stable disease for 2 months||patients|||Number
174121|NCT00093756|Primary|The Primary Endpoint of This Trial is the Proportion of Patients Alive at 1 Year. Phase II Patients Only.|The primary endpoint of this trial is the proportion of patients alive at 1 year (i.e., 365 days) after study registration. Proportion of successes, defined as the number of patients alive at one year divided by the total number of evaluable patients.|At 1 year|Phase II patients are eligible for Primary end point.||percentage of Participants|||Number
174122|NCT00093496|Secondary|Toxicity|Defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 as an adverse event classified as either possibly, probably, or definitely related to study treatment. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.|Participants were evaluated every 6 weeks on treatment (maximum 42 weeks)|In Cohort 1, one patient was found to be ineligible. In Cohort 2, one patient was ineligible and two patients had protocol violations. Therefore, 14 participants in Cohort 1 and eleven participants in Cohort 2 were analyzed for adverse events.||events|||Number
174123|NCT00093496|Secondary|Overall Survival|Defined as the time from registration to date of last follow-up or death due to any cause. Estimated using the method of Kaplan-Meier.|Every 3 months until disease progression and then every 6 months for up to 5 years.|An interim analysis was done on the first 12 eligible participants in each cohort. Due to drug shortage and lack of clinical acttivity, the interim analysis for Cohort 2 was conducted on the first 11 participants.||months||95% Confidence Interval|Median
174124|NCT00093496|Secondary|Times to Progression|Defined as the time from registration to the date of progression or last follow-up, whichever comes first. Estimated using the method of Kaplan-Meier|Participants were evaluated every 6 weeks on treatment (maximum 42 weeks), and followed up to 5 years from registration.|An interim analysis was done on the first 12 eligible participants in each cohort. Due to drug shortage and lack of clinical activity, the interim analysis for Cohort 2 was conducted on the first 11 participants.||months||95% Confidence Interval|Median
174125|NCT00093496|Primary|Proportion of Patients Who Experience a Confirmed Response According to Modified RECIST Criteria.|"Objective response will be measured using the modified RECIST criteria. A confirmed response requires an objective status of complete or partial response on 2 consecutive evaluations occurring 4 or more weeks apart.~Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.~Partial Response (PR): At least a 30% decrease in the sum of the target lesions from the baseline."|Participants were evaluated every 6 weeks on treatment, with median treatment length of 12 weeks (3 week minimum and 42 week maximum).|In Cohort 1, one patient was found to be ineligible. In Cohort 2, one patient was ineligible and two patients had protocol violations. Therefore, 14 participants in Cohort 1 and eleven participants in Cohort 2 were analyzed for the primary endpoint.||proportion of participants|||Number
174126|NCT00093470|Secondary|Overall Survival|Overall survival (OS) is defined as the time from randomization to death from any cause.|Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.|All randomized patients||months||95% Confidence Interval|Median
174127|NCT00093470|Primary|Disease-free Survival|Disease-free survival (DFS) is defined as the time from randomization to relapse or death without relapse.|Assessed monthly for the first 6 months then every 3 months or as clinically indicated, up to 5 years.|All randomized patients||months||95% Confidence Interval|Median
174128|NCT00093379|Secondary|Number of Participants With Progression-Free Survival at 2-Year||2 Years||||||
174129|NCT00093379|Secondary|2-Year Median Overall Survival||2 Years||||||
174130|NCT00093379|Secondary|2-year Local Regional Control||2 Years||||||
174131|NCT00093379|Secondary|Number of Participants With 2-year Colostomy-Free Survival|Colostomy-free survival reported as number of participants who did not develop local recurrence or require salvage resection with colostomy.|2 Years with median study follow up of 19 months|||participants|||Number
174132|NCT00093379|Secondary|Number of Participants With Complete Response at 2 Years|Response determined by computed tomography (CT)/magnetic resonance imaging (MRI), digital rectal examination, and proctoscopy, and a biopsy performed for clinical suspicion of residual or progressive disease. Response Evaluation Criteria in Solid Tumors (RECIST) where evaluation of target lesions Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|2 Years|Three (3) participants were not evaluable for response.||participants|||Number
174133|NCT00093379|Primary|2 Year Failure Free Survival|Treatment failure defined as: Biopsy proven residual disease identified 12 –14 weeks after the conclusion of chemoradiation therapy, Treatment-related mortality or Disease recurrence.|2 years|||participants|||Number
174134|NCT00093145|Secondary|Number of Participants With Adverse Events (AEs)|A Treatment-emergent AE was any AE that began or worsened after the start of study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on the following scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: is fatal or life-threatening; results in persistent or significant disability or incapacity; requires or prolongs in-patient hospitalization; is a congenital anomaly/birth defect in the offspring of a patient; and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above|Day 1 up to 39 cycles|Treated population||participants|||Number
174135|NCT00093145|Secondary|Overall Patient Survival|Overall survival was defined as the time from the day of randomization to patient death (due to any cause), as assessed by post study follow-up on a monthly basis for 3 months and every 3 months. Participants still alive were censored at the last known time that the patient was alive. Patient survival was estimated using Kaplan-Meier methods.|From Day 1 until approximately 44 months.|Treated population||months||95% Confidence Interval|Median
174136|NCT00093145|Secondary|Duration of Response|Duration of response was evaluated by measuring progression-free survival for participants with a complete response or partial response. Progression-free survival was defined as the time from the first dose of study drug to the start of progression or patient death (whichever occurred first). Participants who did not have progression or were still alive were censored at the last known time the patient was progression free. Patients that initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Assessed every 2 cycles, up to a maximum of 39 cycles.|Treated Population - Patients with a Confirmed Complete or Partial Overall Response||months||95% Confidence Interval|Median
174137|NCT00093145|Secondary|Time to Disease Progression|Time to disease progression was measured from the date of first dose of study drug to the start of disease progression. Patients who did not have disease progression at the end of follow-up were censored at the last known time that the patient was evaluated for progression. Progression is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion. Time to disease progression was summarized using Kaplan-Meier methods.|Assessed every 2 cycles, up to a maximum of 39 cycles.|Treated population||months||95% Confidence Interval|Median
174138|NCT00093145|Secondary|Percentage of Participants With a Total Response|Total response was defined as the percentage of participants with stable disease (SD) for ≥ 16 weeks or complete or partial overall response. Stable disease was defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. Progressive disease is at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.|Evaluated every 2 cycles, up to a maximum of 39 cycles.|Treated population||percentage of participants||95% Confidence Interval|Number
174139|NCT00093145|Primary|Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response|Percentage of participants who achieved an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. A partial response (PR) is at least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing, or with the persistence of one or more non-target lesions and/or the maintenance of tumor marker level above the normal limits.|Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months)|The treated population consisted of all randomized participants who received at least one dose of study drug.||Percentage of participants||95% Confidence Interval|Number
174140|NCT00093041|Secondary|Overall Response, Classification|Overall response was evaluated according to RECIST J Natl Cancer Inst 2000;92:205-16.|8 weeks|||participants|||Number
174141|NCT00093041|Primary|Adverse Events|Number of participants reporting at least one adverse event|Overall Study|Number of participants reporting at least one adverse event||participants|||Number
174142|NCT00093015|Secondary|Time to Hospitalization Due to Acute Myocardial Ischemia|Time from randomization to hospitalization due to acute myocardial ischemia. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
174143|NCT00093015|Secondary|Change in Patient Reported Fatigue Relative to Baseline at Week 25|Change in patient reported fatigue measured by the Functional Assessment of Cancer Therapy (FACT) – Fatigue scale from baseline to week 25. Range and direction of scale: 0 = most fatigue; 52 = least fatigue|Baseline and week 25|Subjects with both the baseline and at least post-baseline measurement at week 25 for FACT-fatigue were included in the analysis and were analyzed as randomized. Last observation carried forward (LOCF) using last non-missing post-baseline value was used for missing post-baseline data for subjects who were still on study.||Units on a scale||Standard Deviation|Mean
174144|NCT00093015|Secondary|Rate of Decline in Estimated Glomerular Filtration Rate (eGFR) Relative to Baseline|GFR was estimated using the following MDRD formula: 186 x [Serum creatinine]^(-1.154) x [Age]^(-0.203) x [0.742 if subject is female] x [1.210 if subject is black]. Change from baseline in eGFR at week 49 for each treatment group are presented. The treatment effect of the rate of decline in eGFR per year was estimated using the mixed model.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|Subjects were analyzed as randomized using all available eGFR measurements, except eGFR measurements measured after subjects develop ESRD since creatinine measurements were no longer reliable or meaningful for eGFR calculation.||mL/min/1.73m^2||Standard Deviation|Mean
174145|NCT00093015|Secondary|Time to End Stage Renal Disease|Time from randomization to end stage renal disease (ESRD). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
174367|NCT00090584|Secondary|Change in Incontinence Episodes|Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.|Baseline and 10 weeks|All women with valid bladder diary at baseline and 10 weeks in each treatment group.||incontinence episodes per week||Standard Error|Mean
174146|NCT00093015|Secondary|Time to Congestive Heart Failure|Time from randomization to fatal or non-fatal congestive heart failure(CHF). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
174147|NCT00093015|Secondary|Time to Cerebrovascular Accident|Time from randomization to fatal or non-fatal cerebrovascular accident (CVA). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
174148|NCT00093015|Secondary|Time to Myocardial Infarction|Time from randomization to fatal or non-fatal myocardial infarction (MI). Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
174149|NCT00093015|Secondary|Time to Cardiovascular Mortality|Time from randomization to cardiovascular (CV) mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
174150|NCT00093015|Secondary|Time to All-cause Mortality|Time from randomization to all-cause mortality. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
174151|NCT00093015|Primary|Time to All-cause Mortality or End Stage Renal Disease (ESRD)|Time from randomization to first event of all-cause mortality or ESRD. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
174152|NCT00093015|Primary|Time to All-cause Mortality or Cardiovascular (CV) Events Including Hospitalization Due to Acute Myocardial Ischemia, Congestive Heart Failure (CHF), Myocardial Infarction (MI), and Cerebrovascular Accident (CVA)|Time from randomization to the first confirmed composite event. Kaplan-Meier estimate of the median time was not estimable due to low proportion of participants experiencing at least one events, therefore participants experiencing at least one event were summarized.|Until a primary cardiovascular event (death, myocardial ischemia, congestive heart failure, myocardial infarction or cerebrovascular accident) occurred or 28 March 2009, whichever occurred first|The analysis followed intent-to-treat principles. Subjects were analyzed as randomized using all available follow-up information.||Participants|||Number
174153|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Triglycerides From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.||Percent Change||Standard Deviation|Mean
174154|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average High-density Lipoprotein Cholesterol (HDL-C) From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.||Percent change||Standard Deviation|Mean
174155|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.||Percent Change||Standard Deviation|Mean
174653|NCT00089141|Primary|Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy|Withdrawal of all systemic immunosuppressive treatment after resolution of chronic GVHD, before death or onset of recurrent malignancy|2 years|||participants|||Number
174156|NCT00092677|Other Pre-specified|Percent Change in Time Weighted Average Total Cholesterol From Baseline to End of Follow-up|Mean percent change (time-weighted average over follow-up) from baseline: Time-weighted average calculated using values at week 8, week 24, year 1 and every 6 months with time interval (days) between 2 successive values used as the weighting factor. For the first follow-up value, the weight was the number of days from randomization.|Baseline to End of follow-up (median = 4.35 years)|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication.||Percent Change||Standard Deviation|Mean
174157|NCT00092677|Secondary|Change From Baseline in Peak Transaortic Jet Velocity|Mean change from baseline in peak transaortic jet velocity|Baseline to End of follow-up (median = 4.35 years) or pre-aortic valve replacement|Full Analysis Set: All patients who were randomized, took at least one dose of blinded study therapy and had a baseline and at least one post-randomization assessment without regard to protocol violations or compliance with study medication. 180 patients were excluded from peak transaortic jet velocity due to missing measurements.||m/sec||Standard Deviation|Mean
174158|NCT00092677|Post-Hoc|Incident Cancer|Number of participants with incident cancer|Entire follow-up (median = 4.35 years)|One patient from the 944 patients randomized to ezetimibe/simvastatin 10/40 mg did not receive study medication and was not included.||Participants|||Number
174159|NCT00092677|Post-Hoc|Death Due to Cancer|Number of participants that died due to cancer|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174160|NCT00092677|Other Pre-specified|Death (Any Cause)|Number of participants that died (any cause)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174161|NCT00092677|Other Pre-specified|Nonhemorrhagic Stroke|Number of participants that experienced nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174162|NCT00092677|Other Pre-specified|Hospitalization for Unstable Angina|Number of participants that experienced hospitalization for unstable angina|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174163|NCT00092677|Other Pre-specified|Percutaneous Coronary Intervention (PCI)|Number of participants that experienced percutaneous coronary intervention (PCI)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174164|NCT00092677|Other Pre-specified|Coronary Artery Bypass Grafting (CABG)|Number of participants that experienced coronary artery bypass grafting (CABG)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174165|NCT00092677|Other Pre-specified|Nonfatal Myocardial Infarction (MI)|Number of participants that experienced nonfatal myocardial infarction (MI)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174166|NCT00092677|Other Pre-specified|Congestive Heart Failure (CHF) Due to Progression of Aortic Stenosis (AS)|Number of participants that experienced Congestive Heart Failure (CHF) due to progression of aortic stenosis (AS)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174167|NCT00092677|Other Pre-specified|Aortic Valve Replacement (AVR)|Number of participants that experienced aortic valve replacement (AVR)|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174168|NCT00092677|Other Pre-specified|Cardiovascular Death|Number of participants that experienced cardiovascular death|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174169|NCT00092677|Secondary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of ICE (Ischemic Cardiovascular Events)|Composite endpoint of ICE (ischemic cardiovascular events) consists of cardiovascular death, nonfatal MI, CABG, PCI, hospitalized unstable angina, and nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174170|NCT00092677|Secondary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of AVE (Aortic Valve Events)|Composite endpoint of AVE (aortic valve events) consists of AVR surgery, CHF (as a result of progression of AS), or cardiovascular death|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174171|NCT00092677|Primary|Number of Participants That Experienced One or More Components of the Composite Clinical Endpoint of MCE (Major Cardiovascular Events)|Composite endpoint of MCE consists of cardiovascular death, AVR (aortic valve replacement) surgery, CHF(congestive heart failure) as a result of progression of aortic stenosis, nonfatal MI (myocardial infarction), CABG (coronary artery bypass) surgery, PCI (percutaneous coronary intervention), hospitalized unstable angina, and nonhemorrhagic stroke|Entire follow-up (median = 4.35 years)|Intention-to-Treat||Participants|||Number
174172|NCT00092547|Secondary|Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related PIN, Genital Warts, and Penile/Perineal/Perianal Cancer in Males|The HPV types were determined by PCR testing. Combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related penile/perineal/perianal intraepithelial neoplasia (PIN), genital warts, and penile/perineal/perianal cancer was assessed in male participants.|Up to Month 126|Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.||Cases per 100 person-years at risk||95% Confidence Interval|Number
174173|NCT00092547|Secondary|Combined Incidence of HPV 6/11/16/18-related Persistent Infection and HPV 6/11/16/18-related CIN, AIS, VIN, VaIN, Genital Warts, and Cervical/Vaginal/Vulvar Cancer in Females|The HPV types were determined by polymerase chain reaction (PCR) testing. The combined incidence of HPV 6/11/16/18-related persistent infection and HPV 6/11/16/18-related cervical intraepithelial neoplasia (CIN), adenocarcinoma in situ (AIS), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), genital warts, and cervical/Vaginal/vulvar cancer was assessed in female participants.|Up to Month 126|Per-Protocol Effectiveness population: male participants without protocol violations who received at least 1 dose of qHPV vaccine and at least 1 effectiveness follow-up visit.||Cases per 100 person-years at risk||95% Confidence Interval|Number
174174|NCT00092547|Secondary|Geometric Mean Titers in the Extension Group for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 37)||Month 37 (1 Month Post-dose 3 of qHPV)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations within appropriate day ranges, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
174175|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 31 Postdose 3 of qHPV Vaccine (Month 37)||Month 37 (31 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
174176|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 24 Postdose 3 of qHPV Vaccine (Month 30)||Month 30 (24 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
174177|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 18 Postdose 3 of qHPV Vaccine (Month 24)||Month 24 (18 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
174178|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 12 Postdose 3 of qHPV Vaccine (Month 18)||Month 18 (Month 12 Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
174179|NCT00092547|Secondary|Geometric Mean Titers of Original qHPV Vaccine Cohort for Anti-HPV 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV Vaccine (Month 7)||Month 7 (1 Month Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
174180|NCT00092547|Secondary|Percentage of Participants in the Extension Group Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 of qHPV (Month 37)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 37 (1 Month Post-dose 3 of qHPV)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Month 30, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
174181|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 31 Postdose 3 (Month 37).|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 37 (31 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
174182|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 24 Postdose 3 (Month 30)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 30 (24 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
174183|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 18 Postdose 3 (Month 24)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 24 (18 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
174184|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 12 Postdose 3 (Month 18).|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 18 (12 Months Post-dose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
174185|NCT00092547|Secondary|Percentage of Original qHPV Vaccine Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 1 Postdose 3 (Month 7)|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 7 (1 Month Postdose 3)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1, and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
174197|NCT00092534|Secondary|Subjects With Anti-HPV 16 Titer >/= 20 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20mMU/mL|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.||Participants|||Number
174186|NCT00092547|Primary|Number of Participants Reporting SAEs Related to Study Vaccine or to a Study Procedure in the Long-term Follow-up|"A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment. SAEs considered by the investigator to be possibly, probably, or definitely related to study vaccine or a study procedure were reported."|Month 37 to Month 126|The analysis population was all participants who were vaccinated according to actual treatment received and had safety follow-up.||Participants|||Number
174187|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 126|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
174188|NCT00092547|Primary|Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 126||Month 126 (120 Months Post-dose 3 for Original qHPV Vaccine Cohort and 90 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
174189|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 96|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Cohort and 60 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 qHPV vaccinations, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
174190|NCT00092547|Primary|Geometric Mean Titers for Anti-HPV 6, 11, 16, and 18 at Month 96||Month 96 (90 Months Post-dose 3 for Original qHPV Vaccine Group and 60 Months Post-dose 3 for Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
174191|NCT00092547|Primary|Geometric Mean Titers (GMTs) for Anti-HPV 6, 11, 16, and 18 at Month 72||Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations within appropriate day ranges as defined in the CSR, were seronegative to the respective HPV type at Day 1 (for the Main Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||milliMerck units/mL||95% Confidence Interval|Geometric Mean
174192|NCT00092547|Primary|Percentage of Participants Who Are Seropositive for HPV Types 6, 11, 16, and 18 at Month 72|A participant is considered seropositive for a given HPV type if he or she has a cLIA titer at or above the serostatus cutoff for that HPV type. Serostatus cutoffs are ≥ 20 mMU/mL for HPV 6 and 16, ≥ 16 mMU/mL for HPV 11, and ≥ 24 mMU/mL for HPV 18.|Month 72 (66 Months Post-dose 3 for the Original qHPV Vaccine Cohort and 36 months Post-dose 3 for the Extension Group)|Per-protocol population: participants without protocol violations who received all 3 vaccinations, were seronegative to the respective HPV type at Day 1 (for the Base Vaccination group), or Month 30 (for the Extension Group), and had a valid serology result at the specified time for assessment.||Percentage of participants||95% Confidence Interval|Number
174193|NCT00092547|Primary|Number of Participants Reporting Other (Non-serious) AEs Through Month 18|Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18|Up to Month 18: Injection site AEs were collected from Days 1-5 and other non-serious AEs from Days 1-15 after any vaccination|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.||participants|||Number
174194|NCT00092547|Primary|Number of Participants Reporting SAEs From Month 18 Through Month 37|Tolerability as assessed by the number of participants with clinical adverse experiences from Month 18 through Month 37|Month 18 to Month 37|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.||participants|||Number
174195|NCT00092547|Primary|Number of Participants Reporting Serious Adverse Experiences (SAEs) Through Month 18|"Tolerability as assessed by the number of participants with clinical adverse experiences through Month 18. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgment."|Up to Month 18|All participants who were vaccinated according to actual treatment received (qHPV or placebo) and had safety follow-up.||participants|||Number
174196|NCT00092534|Secondary|Subjects With Anti-HPV 18 Titer >/= 24 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 24 mMU/mL|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.||Participants|||Number
174319|NCT00091026|Primary|Objective Response Rate (Complete or Partial Response) Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST)||Up to 6 months|||percentage of participants||95% Confidence Interval|Number
174320|NCT00090987|Secondary|Viral Transcription Profile of Kaposi's Sarcoma-associated Herpesvirus||12 months||||||
174198|NCT00092534|Secondary|Subjects With Anti-HPV 11 Titer >/= 16 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 16 mMU/mL|Week 4 Postdose 3|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.||Participants|||Number
174199|NCT00092534|Secondary|Subjects With Anti-HPV 6 Titer >/= 20 mMU/mL|Subsequent to protocol registration, an updated serology assay was used in which seropositivity was defined as >/= 20 mMU/mL|Week 4 Postdose 3 (4 weeks after 3rd vaccine dose)|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide data. Only subjects participating in a substudy had blood samples at Month 7.||Participants|||Number
174200|NCT00092534|Primary|Tolerability; Incidence of the Composite Endpoint of HPV 16 or HPV 18 Related CIN2/3 or Invasive Cervical Carcinoma After Completion of the Vaccination Series for Relevant HPV Type|"Tolerability = Number of subjected affected. Incidence Rate per person-years of follow-up.~The tolerability objective was to demonstrate that Gardasil is generally well tolerated by females aged 16-23. The relevant data are presented in the Reported Adverse Events section. No formal statistical hypothesis testing were performed for this objective."|Follow-up through end of study (4 years)|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase chain reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data.||Incidence per 100 person-years|||Number
174201|NCT00092521|Primary|Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer]||Follow-up through end of study (4 years)|"Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and PCR negative to the relevant type through Month 7, and must provide follow-up data.~Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population."||incidence rate per 100 person-years|||Number
174202|NCT00092521|Primary|Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer||Follow-up through end of study (4 years)|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant type at Day 1 and Polymerase Chain Reaction (PCR) negative to the relevant type through Month 7, and must provide follow-up data. Group 2 Base Study Monovalent HPV Vaccine was not part of the pre-specified efficacy analysis population.||incidence rate per 100 person-years|||Number
174203|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||mMU/mL||95% Confidence Interval|Geometric Mean
174204|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||Subjects|||Number
174205|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 18 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||mMU/mL||95% Confidence Interval|Geometric Mean
174206|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 18 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 18 titer ≥ 24 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||Subjects|||Number
174207|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||mMU/mL||95% Confidence Interval|Geometric Mean
174208|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||Subjects|||Number
174209|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 16 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||mMU/mL||95% Confidence Interval|Geometric Mean
174210|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 16 by Week 4 Postdose 3|Seropositivity is defined as an anti-HPV 16 titer ≥ 20 milliMerck units per milliliter (mMU/mL). Seroconversion is defined as going from seronegative to seropositive.|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||mMU/mL|||Number
174211|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||mMU/mL||95% Confidence Interval|Geometric Mean
174321|NCT00090987|Secondary|Mechanisms of Primary and Secondary Resistance to Imatinib Therapy|Mutations in the juxtamembrane or kinase membrane of the c-kit or PDGF receptors at baseline or time of progression|12 months||||||
174322|NCT00090987|Secondary|Pharmacokinetic Profile of Imatinib and Antiretrovirals||12 months||||||
174212|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||Subjects|||Number
174213|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 11 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||mMU/mL||95% Confidence Interval|Geometric Mean
174214|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 11 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 11 titer ≥ 16 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||Subjects|||Number
174215|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||mMU/mL||95% Confidence Interval|Geometric Mean
174216|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to female subjects 10-15 years and 16-23 years.||Subjects|||Number
174217|NCT00092495|Primary|Geometric Mean Titer (GMT) for HPV 6 by Week 4 Postdose 3||Week 4 Postdose 3 (Month 7)|: Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||mMU/mL||95% Confidence Interval|Geometric Mean
174218|NCT00092495|Primary|Number of Subjects Who Seroconverted for HPV 6 by Week 4 Postdose 3|"Seroconversion is defined as going from seronegative to seropositive.~Seropositivity is defined as an anti-HPV 6 titer ≥ 20 milliMerck units per milliliter (mMU/mL)."|Week 4 Postdose 3 (Month 7)|Per-protocol population: subjects must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. Restricted to subjects receiving 100% dosage.||Subjects|||Number
174219|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)|Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
174220|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)|SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
174221|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)|CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
174222|NCT00092456|Other Pre-specified|Number of Subjects Discontinued Due to Clinical Adverse Experiences|A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
174223|NCT00092456|Other Pre-specified|Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)|Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
174224|NCT00092456|Other Pre-specified|Number of Subjects With Vaccine-Related Clinical AEs (CAEs)|CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
174323|NCT00090987|Secondary|Cytokine Profiles Before and After Imatinib Therapy||12 months||||||
174324|NCT00090987|Secondary|Inhibition of Platelet-derived Growth Factor-receptor as Assessed by Immunohistochemistry||12 months||||||
175443|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
174225|NCT00092456|Other Pre-specified|Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)|Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|All subjects who were vaccinated and followed up||Participants|||Number
174226|NCT00092456|Other Pre-specified|Number of Subjects With Clinical Adverse Experiences (CAEs)|Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product|Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first|Safety Population: All subjects who were vaccinated and followed up||Participants|||Number
174227|NCT00092456|Other Pre-specified|Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).|Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA|42 days following the 3rd vaccination|Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.||units/mL||95% Confidence Interval|Geometric Mean
174228|NCT00092456|Primary|Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]|Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8]|42 days following the 3rd vaccination|Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.||dilution units||95% Confidence Interval|Geometric Mean
174229|NCT00092443|Secondary|Number of Subjects With ≥3 Fold Rise in Antibody Titer|Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)|14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen EIA prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range.||Participants|||Number
174230|NCT00092443|Primary|Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.|G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition|At least 14 days following the 3rd vaccination|Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen Enzyme immunoassay (EIA) prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range.||Participants|||Number
174231|NCT00092417|Other Pre-specified|Number of Participants With Fevers ≥101.0°F [≥38.3°C]|Maximum reported oral or equivalent temperature ≥101.0°F [≥38.3°C] was reported Day 1 through Day 21 postvaccination.|Day 1-21 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data. 5 participants in the Zoster Vaccine Higher Potency group and 3 participants in the Zoster Vaccine Lower Potency group were not included in this analysis since these participants were without a follow-up.||Participants|||Number
174232|NCT00092417|Other Pre-specified|Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes|Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be zosteriform rash by the study physician and polymerase chain reaction (PCR).|Day 1-42 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.||Participants|||Number
174233|NCT00092417|Other Pre-specified|Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions|Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be varicelliform rash by the study physician and polymerase chain reaction (PCR).|Day 1-42 postvaccination|The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.||Participants|||Number
174234|NCT00092417|Primary|Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)||Day 1-5 postvaccination|The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.||Participants|||Number
174235|NCT00092417|Primary|Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)|The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level.|Day 1-42 post vaccination|The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.||Participants|||Number
174236|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
174237|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
174238|NCT00092131|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
174239|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
174240|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 12 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
174241|NCT00092131|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 2 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
174242|NCT00092131|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
174243|NCT00092131|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
174244|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
174245|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose||0-90 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
174246|NCT00092131|Secondary|Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
174247|NCT00092131|Primary|Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In Participants with EIB, the percent change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
174248|NCT00092118|Secondary|Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period|Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.|Baseline and Week 6|The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no baseline or treatment period data were available||Score on a scale||95% Confidence Interval|Least Squares Mean
174370|NCT00090545|Primary|Progression Free Survival|Determine whether BAY 43-9006 when used to treat metastatic prostate cancer is associated with having 50% of Patients Progression Free at 4 Months by clinical, radiographic, and prostatic specific antigen (PSA)criteria.|4 months|||months||95% Confidence Interval|Median
174249|NCT00092118|Secondary|Patient’s Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period|An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.|At the end of the 6 week treatment period|The analysis was performed using a modified intention-to-treat (MITT) approach. Patients were excluded if no treatment period data were available.||Score on a scale||95% Confidence Interval|Least Squares Mean
174250|NCT00092118|Primary|Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis|Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)].|6 week treatment period (from baseline though the end of week 6)|The primary efficacy analyses were performed using a modified intention-to-treat (MITT) approach. All patients with efficacy measurements, both at baseline and during the treatment period were included.||Score on a scale||95% Confidence Interval|Least Squares Mean
174251|NCT00091962|Secondary|Disease-Specific Health-Related Quality of Life|The 12-item Duke Activity Status Index (DASI). Scores range from 0-58.2, and higher scores the better the functional capacity (Am J Cardiol. 1989;64(10):651-654).|8 months post CABG|||units on a scale||Standard Error|Mean
174252|NCT00091962|Secondary|Generic Physical Health-Related Quality of Life|"The 36-item Medical Outcomes Study Form (v.2) Physical Component Scale (SF-36 PCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better.~Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User’s Manual. 2nd ed. Boston, MA: New England Medical Center; 1994."|8 months post CABG|||participants||Standard Error|Mean
174253|NCT00091962|Secondary|Hamilton Rating Scale for Depression|The 17-item Depression Interview and Structured Hamilton (DISH) version of the Hamilton Rating Scale for Depression Standard provides an accurate DSM-IV diagnosis of a cardiac patient’s mood disorder and a reliable HRS-D score. Range 0-52. Higher scores are worse. Psychosom Med. 2002;64(6):897-905|8 months post CABG|||units on a scale||Standard Error|Mean
174254|NCT00091962|Primary|Generic Mental Health-Related Quality of Life|"The 36-item Medical Outcomes Study Form (v.2) Mental Component Scale (SF-36 MCS). Range 0-100; Population norm is 50 with standard deviation of 10. Higher scores are better.~Ware J, Kosinski M, Keller S. SF-36 Physical and Mental Health Summary Scales: A User’s Manual. 2nd ed. Boston, MA: New England Medical Center; 1994."|Measured 8 months post-CABG|||units on a scale||Standard Error|Mean
174255|NCT00091949|Secondary|Composite Outcome of Fatal or Non-fatal Stroke, Fatal or Non-fatal MI or Episode of Serious Congestive Heart Failure||5 years|||participants|||Number
174256|NCT00091949|Secondary|Decline in Cognitive Status|Change in modified mental status examination (3MS) score from baseline to exit. Theoretical range of 3MS scores is 0-100. Baseline scores ranged from 22-100.|Annual measures from baseline to exit (up to 5 years)|Participants with baseline and at least 1 follow-up modified mini-mental examination score.||units on a scale||Standard Error|Mean
174257|NCT00091949|Secondary|All Cause Mortality||5 years|||participants|||Number
174258|NCT00091949|Secondary|Development of Overt Diabetes||5 years|||participants|||Number
174259|NCT00091949|Secondary|Acute Coronary Syndrome|Fatal or non-fatal acute myocardial infarction or unstable angina|5 years|||participants|||Number
174260|NCT00091949|Secondary|Fatal or Non-fatal Stroke Alone||5 years|||participants|||Number
174261|NCT00091949|Primary|Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction||Up to 5 years|||participants|||Number
174262|NCT00091832|Secondary|Number of Participants With Hypercalcemia|Occurrence of grade 3 or 4 hypercalcemia according to the Common Terminology Criteria for Adverse Events (CTCAE) v3. A summary of hypercalcemia events is reported under adverse events.|Day 1 to Week 57|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Participants|||Number
174263|NCT00091832|Secondary|Number of Participants With Skeletal Related Events|Skeletal Related Events (SRE) are defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|From Day 1 to Week 25|All participants who were exposed to investigational product.||Participants|||Number
174264|NCT00091832|Secondary|Time to First Skeletal Related Event|Skeletal Related Event (SRE) defined as ≥ 1 of the following: pathological bone fracture, spinal cord compression, surgery or radiation therapy to bone (including the use of radioisotopes).|Day 1 to Week 25|All participants who were exposed to investigational product.||Days||95% Confidence Interval|Median
174265|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Osteocalcin|Percent change from Baseline to Week 25 in osteocalcin calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174266|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Osteocalcin|Percent change from Baseline to Week 13 in osteocalcin calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174267|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Bone Specific Alkaline Phosphatase (BSAP)|Percent change from Baseline to Week 25 in BSAP calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174268|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Bone Specific Alkaline Phosphatase (BSAP)|Percent change from Baseline to Week 13 in bone specific alkaline phosphatase (BSAP) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174269|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)|Percent change from Baseline to Week 25 in TRAP5b calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174270|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Tartrate-resistant Acid Phosphatase 5b (TRAP5b)|Percent change from Baseline to Week 13 in tartrate-resistant acid phosphatase 5b calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174271|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in P1NP|Percent change from Baseline to Week 25 in procollagen 1 N-terminal peptide (P1NP) calculated using ((Week 25 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174272|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Procollagen I N-terminal Peptide (P1NP)|Percent change from Baseline to Week 13 in procollagen 1 N-terminal peptide calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174273|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Serum C-telopeptide (CTX)|Percent change from Baseline to Week 25 in type I serum C-telopeptide calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174274|NCT00091832|Secondary|Percent Change From Baseline to Week 13 in Serum C-Telopeptide (CTX)|Percent change from Baseline to Week 13 in type I serum C-telopeptide (CTX) calculated using ((Week 13 value - Baseline value) / Baseline value) x 100.|Baseline and week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174275|NCT00091832|Secondary|Time to 65% or More Reduction in Urinary N-telopeptide (uNTX) From Baseline|Kaplan-Meier estimate of the median time from enrollment to the first occurrence of a reduction of uNTx of ≥ 65% compared to Baseline. For participants whose uNTx did not fall below 65% of the Baseline value, the time was censored at time of last evaluation of uNTx.|Baseline to Week 57|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Days||Inter-Quartile Range|Median
174276|NCT00091832|Secondary|Number of Participants Achieving 65% or More Reduction in uNTX From Baseline at Week 25|The number of participants achieving a 65% reduction or more in uNTX from Baseline at Week 25. Calculation used is ((Week 25 value - Baseline value) / Baseline value) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Participants|||Number
174277|NCT00091832|Secondary|Number of Participants Achieving 65% or More Reduction in Urinary N-telopeptide (uNTx) From Baseline at Week 13|The number of participants achieving a 65% reduction or more in uNTx from Baseline at Week 13. Calculation used is ((Week 13 value - Baseline value) / Baseline value ) x 100 and participants were considered having a 65% reduction or more if their value was ≤ -65%.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a Baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Participants|||Number
174278|NCT00091832|Secondary|Percent Change From Baseline to Week 25 in Urinary N-telopeptide (uNTx)|Percent change from Baseline to Week 25 in Urinary N-telopeptide (uNTx) calculated using ((Week 25 value - Baseline value) / Baseline value) x 100.|Baseline and Week 25|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174395|NCT00090259|Secondary|Number of Participants That Experienced Cardiovascular Hospitalization||Entire follow-up (median = 4.7 years)|Intention-to-Treat||Participants|||Number
174396|NCT00090259|Secondary|Number of Participants That Were Hospitalized for Heart Failure||Entire follow-up (median = 4.7 years)|Intention-to-Treat||Participants|||Number
174397|NCT00090259|Secondary|Number of Participants That Died (Any Cause)||Entire follow-up (median = 4.7 years)|Intention-to-Treat||Participants|||Number
174279|NCT00091832|Primary|Percent Change From Baseline to Week 13 in Creatinine-adjusted Urinary N-telopeptide (uNTx/Cr)|Percent change from Baseline to Week 13 in Urinary N-telopeptide corrected by creatinine (uNTx/Cr) calculated using ((Week 13 value - Baseline value) / Baseline value ) x 100.|Baseline and Week 13|Primary Efficacy Subset, composed of all participants who were randomized, received at least one dose of denosumab or bisphosphonate, and had both a baseline and at least one postbaseline measurement of Urinary N-telopeptide corrected by creatinine (uNTx/Cr). Analysis was by Intention-to-Treat (ITT).||Percent change||Standard Deviation|Mean
174280|NCT00091819|Primary|Clinical Response|The Clinical Response for each patient was determined by the investigator by assessing a patient's clinical signs and symptoms at the specified evaluation compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.|7-14 days following end of antibiotic treatment|Data for the all-treated (AT) population are presented. the AT and clinically evaluable (CE) populations were considered co-primary.||participants|||Number
174281|NCT00091793|Secondary|Distal Radius Total Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174282|NCT00091793|Secondary|Distal Radius Cortical Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174283|NCT00091793|Secondary|Distal Radius Trabecular Volumetric Bone Mineral Density Percent Change From Baseline at Month 24|Volumetric Bone Mineral Density Assessed by Quantitative Computerized Tomography (QCT).|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174284|NCT00091793|Secondary|Total Body (Without Head) Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174285|NCT00091793|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174286|NCT00091793|Secondary|Trochanter Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174287|NCT00091793|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174288|NCT00091793|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174289|NCT00091793|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|24 Months|Randomized subjects who have a non-missing baseline and at least 1 non-missing postbaseline evaluation at or prior to month 24. LOCF was used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174290|NCT00091572|Secondary|Duration of Objective Response|Duration of objective response was measured from the time the criteria were met for complete response or partial response to the first date that recurrent or progressive disease was objectively documented.|Treatment continued until disease progression or unacceptable toxicity.|All responders||Months||95% Confidence Interval|Median
174291|NCT00091572|Secondary|Objective Response Rate in Subjects With Measurable Lesions|Based on investigator's assessment of response in subjects with measurable lesions. Objective response = complete response + partial response. Complete response = disappearance of all target lesions. Partial response = at least a 30% decrease in the sum of longest diameter of target lesions taking as reference the baseline sum longest diameter.|Treatment continued until disease progression or unacceptable toxicity.|Intent to treat population with measurable disease at Baseline.||Ratio||95% Confidence Interval|Median
174292|NCT00091572|Primary|Overall Survival|Overall Survival was defined as the time from the date of randomization to the date of death from any cause.|The final analysis was to be performed when at least 616 deaths had occurred.|Intent to Treat Population||Months||95% Confidence Interval|Median
174293|NCT00091572|Secondary|Progression Free Survival|Progression free survival was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause.|Treatment continued until disease progression or unacceptable toxicity. Patients will be followed for survival.|Intent to Treat Population||Months||95% Confidence Interval|Median
174294|NCT00091507|Secondary|Cardiac Arrest or Acute Mortality|Outcome for all participants (composite of cardiac arrest or acute mortality)|Prehospital setting through hospitalization|||participants|||Number
174295|NCT00091507|Secondary|Mortality|Outcome for all participants (mortality at 30 days).|30 days|30 day mortality.||participants|||Number
174296|NCT00091507|Secondary|Heart Failure or Death|Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days)|30 days|||participants|||Number
174297|NCT00091507|Secondary|Cardiac Arrest|Outcome for all participants who had a cardiac arrest from initial contact in the prehospital setting through their subsequent hospitalization.|1 to 18 hours (From prehospital setting through hospitalization.)|||participants|||Number
174298|NCT00091507|Primary|Progression of Acute Coronary Syndrome to Myocardial Infarction|Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results.|24 hours|||participants|||Number
174299|NCT00091442|Primary|Time to Progression|Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.|From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled|Intent to Treat: For patients who were progression free at the time of data cutoff, data were censored for time to progression at the time of their last tumor assessment.||Months||95% Confidence Interval|Median
174300|NCT00091442|Secondary|Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR)|Number of participants in the evaluable population who achieved a CR or PR as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: Disappearance of all target lesions and PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Response was assessed by Computed Tomography (CT)/Magnetic Resonance Imaging (MRI).|Up to 30 to 42 days after last dose of study medication|Evaluable population: Included all randomized participants who received at least 1 dose of study medication (DOXIL or docetaxel), and who had at least 1 postbaseline tumor assessment.||Participants|||Number
174301|NCT00091442|Secondary|Overall Survival|Time interval in months between the date of randomization and the participant's death from any cause.|From the date of randomization until the participant's death from any cause, as assessed until approximately 485 death events were observed which is assessed approximately 25 months after the last patient was enrolled|Intent to Treat: If the date of death was unknown, the data were censored at the date that the participant was last known to have been alive.||Months||95% Confidence Interval|Median
174302|NCT00091390|Secondary|Clinical Progression Including Local/Regional and Distant Relapse||From registration to the date of local/regional progression or distant relapse, or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.||||||
174303|NCT00091390|Secondary|Disease-specific Survival||From registration to the date of death due to prostate cancer or other disease related cause. Analysis occurs after each patient has had 3 years of follow-up.||||||
174304|NCT00091390|Secondary|Overall Survival||From registration to the date of death or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.||||||
174305|NCT00091390|Secondary|Biochemical Failure||From registration to the date of biochemical failure or last follow-up. Analysis occurs after each patient has had 3 years of follow-up.||||||
174306|NCT00091390|Secondary|Acute Severe GU and GI Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Within 9 Months of Starting Treatment||From registration until 9 months from the start of treatment||||||
174307|NCT00091390|Primary|Late Severe Genitourinary (GU) and Gastrointestinal (GI) Toxicity|Eighteen-month rate of late severe (grade 3-5) genitourinary (GU) and gastrointestinal (GI) toxicity, defined as starting more than 9 months from treatment start, and graded by CTCAE v3.0|Beginning nine months after start of treatment.|All eligible patients.||percentage of participants||95% Confidence Interval|Number
174308|NCT00091273|Secondary|Measure of Tumor-antigen-specific Immunity in PBMC by Elispot Assay||Days 1,8,15,22,29,36,43,50 and Month 3|All treated subjects were assessed.||participants|||Number
174309|NCT00091273|Primary|Measure of Tumor-antigen-specific Immunity in SIN by ELIspot Assay||Day 22|All treated subjects were assessed.||participants|||Number
174310|NCT00091273|Primary|Safety of the Vaccine|Participants kept a toxicity diary during the time frame of interest which was reviewed with a study clinician at each visit.|Days 1,8,15,22,29,36,43,50|All treated subjects were assessed.||participants|||Number
174311|NCT00091169|Secondary|Proportion of Patients With Stable or Improving Performance Status at 4 Weeks|Performance status (PS) was measured using Eastern Cooperative Oncology Group performance status scale. Lower score represents better PS. Change in PS was calculated by PS at week 4- PS at baseline. Patients with negative value for change in PS were considered to have stable or improving PS.|assessed at baseline and 4 weeks after randomization|All randomized patients who had performance status data at baseline and 4 weeks||proportion of participants||95% Confidence Interval|Number
174312|NCT00091169|Secondary|Prevalence of Carnitine Deficiency at 4 Weeks|Carnitine deficiency is defined as a ratio of acylcarnitine (total-free) to free carnitine > 0.4 μmol/L or free carnitine < 35 μmol/L for males and < 25 μmol/L for females.|assessed at 4 weeks after randomization|All randomized patients who had carnitine data at 4 weeks||proportion of participants||95% Confidence Interval|Number
174313|NCT00091169|Secondary|Mean Score Change in Pain Measured With Brief Pain Inventory From Baseline to 4 Weeks|Pain was measured using Brief Pain Inventory (BPI). The mean of the 4 severity items (range: 0-10 with 0 representing no pain and 10 representing pain as bad as you can imagine) was used to measure pain severity. Score change= BPI score at 4 weeks - BPI score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported BPI score at both baseline and 4 weeks||units on a scale||95% Confidence Interval|Mean
174314|NCT00091169|Secondary|Mean Score Change in Depression Measured With CES-D Between 4 Weeks and Baseline|Depression was measured using Center for Epidemiologic Studies Depression Scale (CES-D). The sum of the scores for all 20 items (range: 0-60) was used to assess depression level, and higher scores indicated a higher level of depression. Score change= CES-D score at 4 weeks - CES-D score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported CES-D score at both baseline and 4 weeks||units on a scale||95% Confidence Interval|Mean
174315|NCT00091169|Secondary|Mean Score Change in Fatigue Measured With FACIT-F From Baseline to 4 Weeks|Fatigue was measured using Functional Assessment of Cancer Therapy- Fatigue subscale (FACIT-F). The sum of the scores for all 13 items (range: 0-52) included in the scale was used to measure fatigue level, and lower score represented worse fatigue. Score change= FACIT-F score at 4 weeks - FACIT-F score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients who reported FACIT-F score at both baseline and 4 weeks||units on a scale||95% Confidence Interval|Mean
174316|NCT00091169|Primary|Mean Score Change in Fatigue Measured With Brief Fatigue Inventory From Baseline to 4 Weeks|Fatigue was measured using Brief Fatigue Inventory (BFI). The average of all 9 items included in the scale (range: 0-10) was used to measure fatigue level, and a higher average represented worse fatigue. Score change= BFI score at 4 weeks - BFI score at baseline.|assessed at baseline and 4 weeks after randomization|All randomized patients||units on a scale||95% Confidence Interval|Mean
174317|NCT00091026|Secondary|Overall Survival|Time from randomization until death from any cause. Analyzed using the Kaplan-Meier (1958) estimator and their associated 5% confidence intervals determined using the method described in Brookmeyer and Crowley.|36 months|||Months||95% Confidence Interval|Median
174318|NCT00091026|Secondary|Progression-free Survival|Median progression-free survival time (time from randomization to disease progression or death from any cause). Analyzed using the Kaplan-Meier (1958) estimator and their associated 95% confidence intervals determined using the method described in Brookmeyer and Crowley.|36 months|||months||95% Confidence Interval|Median
174325|NCT00090987|Primary|Proportion of Patients Who Achieve a Clinical Response|Clinical response = Complete Response (absence of residual disease) or Partial Response defined as no new lesions (skin or oral), or no new visceral sites of involvement (or the appearance or worsening of tumor-associated edema or effusions); AND 50% or greater decrease in the number of lesions lasting for >4 weeks; OR Complete flattening of at least 50% of all previously raised lesions OR A 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions|20-24 weeks|||proportion|||Number
174326|NCT00090844|Secondary|Disease-free Survival Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|Every 6 months for 2 years then annual for 3 more years. Patients will be seen, laboratory specimens will be drawn. Menses records will be collected and reviewed. Concomitant medications will be updated.|5 years after end of chemotherapy||||||
174327|NCT00090844|Secondary|Quality of Life as Assessed by FACT-ES Monthly During Treatment, Every Very 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|FACT-ES (v4/4a) quality of life validated tool combines 18 item endocrine subscale (ES) with standardized breast cancer quality of life measure. Administered monthly during treatment, every very 6 months beginning in month 6 for 2 years and then annually for 3 years.|Baseline, through chemotherapy then 5 years||||||
174328|NCT00090844|Secondary|Alternative Markers of Ovarian Failure as Assessed by Inhibin A and Inhibin B Every 6 Months Beginning in Month 6 for 2 Years and Then Annually for 3 Years|Inhibin A & inhibin B are collected at baseline, end of chemotherapy, then every 6 months for 2 years then annually for 3 more years. Inhibin A & Inhibin B are markers of ovarian failure.|Baseline, end of chemotherapy then 5 years||||||
174329|NCT00090844|Secondary|Chemotherapy-related Amenorrhea|Chemotherapy-related amenorrhea as assessed by record of menses monthly during treatment. Record of menses is completed by patient throughout their time on study through chemotherapy and for 5 years.|Baseline, end of chemotherapy then 5 years||||||
174330|NCT00090844|Primary|Time to Resumption of Menses|Ovarian function as assessed by follicle stimulating hormone (FSH) and record of menses every 6 months beginning in month 6 for 2 years and then annually for 3 years|Baseline, end of chemotherapy then 5 years|||months||Full Range|Median
174331|NCT00090779|Secondary|Time to Treatment Initiation or Death|5th, 10th, 25th, 50th and 75th percentiles in weeks from randomization to treatment initiation or death|5 years since randomization|All eligible subjects were included except one subject in IT arm with baseline multidrug resistance.||weeks||95% Confidence Interval|Number
174332|NCT00090779|Secondary|Time From Study Entry in DT Arm Participants or From Week 36 in IT Arm Participants to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization for DT arm or from week 36 for IT arm to meeting the criteria for treatment initiation or re-initiation which include two consecutive CD4 count below 350 cells/mm^3 at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.|96 weeks since randomization|Through database cutoff for DSMB review (by July 2, 2009). The analysis includes only those in the IT arm who continued ART through week 36 (n=49), compared to all in the DT arm (n=64).||weeks||95% Confidence Interval|Number
174333|NCT00090779|Secondary|Time to Meeting the Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|5th, 10th, 25th, 50th, 75th and 90th percentiles in weeks from randomization to meeting the criteria for treatment initiation or re-initiation which include CD4 count below 350 cells/mm^3 on two consecutive measurements at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or CDC Category B or C diagnosis.|96 weeks since randomization|Throughout database cutoff for DSMB review (by July 2, 2009).||weeks||95% Confidence Interval|Number
174334|NCT00090779|Secondary|Number of Participants in IT Arm Off Treatment Before 36 Weeks|The study provided fixed-dose combination emtricitabine/tenofovir DF 200/300 mg orally once daily and lopinavir/ritonavir 200/50 mg administered either as two tablets twice daily or four tablets once daily, for the first 36 weeks for individuals in the IT arm.|At Week 36|All 66 eligible subjects in IT arm were included.||participants|||Number
174335|NCT00090779|Secondary|Number of Participants Meeting Clinical, Virologic, or Immunologic Criteria for Treatment Initiation or Re-initiation|The clinical, virologic, or immunologic criteria for treatment initiation or re-initiation include CD4 count below 350 cells/mm^3 on two consecutive determinations at least 4 weeks apart, at least 12 weeks into the study or 12 weeks post-treatment discontinuation, (2) confirmed CD4 count below 200 cells/mm^3 or CD4 percent below 14% at any time on study, (3) confirmed HIV-1 RNA level above 750,000 copies/mL 4 weeks into the study or above 200,000 copies/mL 12 weeks or more into the study, or (4) CDC Category B or C diagnosis.|96 weeks since randomization|All 130 eligible subjects were included.||Participants|||Number
174336|NCT00090779|Secondary|Change in CD4 Counts Cells/mm^3 From Week 36 for IT Arm and From Week 0 for DT Arm||IT arm (weeks 36, 60, 72, 84 and 96) and DT arm (weeks 0, 24, 36, 48 and 60)|One subject in IT arm with multidrug resistance at baseline was excluded from this analysis.||Change in Log10 transformed CD4 Counts||Standard Deviation|Mean
174337|NCT00090779|Primary|Number of Participants Experiencing Either a CDC Category B or C Diagnosis, CD4<200 Cells/mm^3 or CD4 Percent <14%.||96 weeks since randomization|||participants|||Number
174348|NCT00090766|Primary|Number of Participants With Adverse Events Leading to Discontinuation of the Study Drug|An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to discontinuation of the study drug is reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
174368|NCT00090584|Primary|Proportion of Women Who Meet Definition of Success|Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a >70% reduction in number of incontinence episodes as compared to baseline.|8 months|All women who completed the 8 months assessment or were known to return to drug use prior to that time.||participants|||Number
174338|NCT00090779|Primary|Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 72 and 76 for the IT Arm and Ranked log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at Weeks 36 and 40 for the DT Arm|The primary endpoint is (i) average wk 36 and 40 VL for those who continued to wk 36 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the “failures” who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.|IT arm (weeks 72 and 76) and DT arm ( weeks 36 and 40)|Participants in follow-up at least 72 weeks since randomization were included.||rank||Full Range|Median
174339|NCT00090779|Primary|Ranked Log10 HIV-1 RNA Viral Load (log10 Copies/mL) Averaged at 72 and 76 Weeks for the IT Arm and DT Arm|The primary endpoint is (i) the average of log10 viral loads (VL) at wks 72 and 76 for participants who continued to wk 72 off ARV for the DT arm, (ii) average wk 72 and 76 VL for those who continued to wk 36 off ARV for the IT arm and (iii) an assigned VL rank for the “failures” who needed ARVs or met criteria for entry into Step 2 prior to these study visits. The assigned rank for the failures was either the last observed rank carried forward or the worst rank relative to the other possible outcomes. This approach was designed to, if anything, bias against finding a treatment effect. To illustrate, consider five participants who enter the study (A, B, C, D, and E), 4 of whom (A, B, C, D) make it to 72 wks off therapy with RNA levels that increase from A to D. Participant E enters Step 2 at wk 12, at which time his RNA is in the 50th percentile. This rank would be carried forward, so the rank order of the log10 HIV-1 RNA endpoints would be A B E C D.|At Weeks 72 and 76|Participants in follow-up at least 72 weeks since randomization were included.||rank||Full Range|Median
174340|NCT00090766|Secondary|Number of Participants Who Experienced Episodes of Rejection Over Time|Participants with biopsy proven active rejection are reported.|Up to Week 26|The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.||participants|||Number
174341|NCT00090766|Secondary|Mean Elimination Half-Life of Valganciclovir Over Time|The Elimination Half-Life Period is defined as the time measured for the plasma concentration to decrease by half to its original concentration. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14|The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken.||hours||Standard Deviation|Mean
174342|NCT00090766|Secondary|Mean Maximum Plasma Concentration of Valganciclovir Over Time|Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration of Valganciclovir. Participants with kidney, liver and heart transplant were analyzed. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day (D) 7 to D 14; and at Week (W) 6, W 10, and W 14|The PK analysis population comprised all participants from studies WP16296, WP16303 and WV16726 who completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.||mcg/mL||Standard Deviation|Mean
174343|NCT00090766|Secondary|Number of Participants Who Experienced Graft Loss|Graft loss was defined as impairment of organ function to such a degree that the participant died or underwent re-transplantation.|Up to Week 26|ITT population: The ITT population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.||participants|||Number
174344|NCT00090766|Secondary|Number of Participants With Treatment Failures|Treatment failure was defined as either the development of CMV (viremia, antigenemia or test positive) requiring treatment up to day 100 post-transplant (i.e, while undergoing prophylaxis with valganciclovir up to day 100) or discontinuation of study medication due to lack of efficacy or to toxicity.|Up to Week 26|The Intent to Treat (ITT) population comprised all participants who received at least one dose of the study drug, whether on-study or prematurely withdrawn.||participants|||Number
174345|NCT00090766|Secondary|Number of Participants With Cytomegalovirus Disease Over Time|Cytomegalovirus (CMV) disease is defined as syndrome or tissue invasive disease in which CMV virus was identified in blood, urine, biopsy or other suitable specimen, which could be in conjunction with one or more of the following events: a) CMV syndrome was defined as virus present in blood or other suitable specimen, plus fever, and any of the following: leukopenia, atypical lymphocytosis, thrombopenia or elevated hepatic transaminases (for non-liver recipients). b) The diagnosis of organ specific tissue invasive CMV disease was evidence of CMV in the tissue (CMV inclusion bodies or in situ detection of CMV antigen or DNA), plus signs/symptoms of organ dysfunction.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
174346|NCT00090766|Primary|Number of Participants With 4 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry|The number of participants experiencing a 4 grade shift (example from Grade 0 to Grade 4) from BL in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
174347|NCT00090766|Primary|Number of Participants With 3 Grade Shift From Baseline of Adverse Events in Hematology and Serum Chemistry|The number of participants experiencing a 3 grade shift (example from Grade 0 to Grade 3) from baseline (BL) in hematology and serum chemistry laboratory parameters are reported. The data was analyzed for overall study only.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
174361|NCT00090584|Secondary|Symptom Improvement|"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?"|10 weeks|Participants who completed the satisfaction item at 10 weeks.||participants|||Number
174349|NCT00090766|Primary|Number of Participants With Any Adverse Events and Any Serious Adverse Events|An AE was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any experience or a significant hazard, that is fatal, life-threatening, requires in-patient hospitalization or prolongation of existing one, results in persistent or significant disability, is a congenital anomaly, is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
174350|NCT00090766|Primary|Number of Participants With Opportunistic Infections|Opportunistic infections included oral candidiasis, candidiasis, herpes simplex, cytomegalovirus antigen positive, cytomegalovirus test positive. The number of participants with opportunistic infections are reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
174351|NCT00090766|Primary|Number of Participants With Adverse Events Leading to Dose Interruption or Modification|An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation in participant administered a pharmaceutical product, which did not necessarily have to have a causal relationship with this treatment. The number of participants with AEs leading to dose interruptions or modifications are reported.|Up to Week 26|Safety population included all participants who received at least one dose of valganciclovir.||participants|||Number
174352|NCT00090766|Primary|Mean Area Under the Concentration-Time Curve From 0 to 24 Hours of Valganciclovir|Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. The AUC 0-24 hours is area under the plasma concentration-time curve from time zero through 24 hours after dosing. A compartmental model was used to measure the plasma concentrations of valganciclovir. One participant was not analyzed for this outcome measure as the participant underwent both a kidney and liver transplant.|Pre-dose; 1-3, 3-7, 7-12 hours post dose on any day between Day 7 to Day 14; Week 6, Week 10, and Week 14|Pharmacokinetic (PK) population comprised of all participants from studies WP16296, WP16303 and WV16726 who had completed the specified treatment and from whom at least one plasma sample was taken. Here n represents number of participant with specific transplant i.e., kidney, liver, and heart.||mcg*hr/mL||Standard Deviation|Mean
174353|NCT00090753|Secondary|Percentage of Patients Who Had at Least 1 Adverse Event|See the adverse events section of the results for more information.|From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)|Intent-to-treat population: All patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA.||Percentage of participants|||Number
174354|NCT00090753|Primary|Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation|Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.|Baseline to the end of the study (Up to 49 Months)|Analysis includes participants from the Intent-to-treat population (all patients who received at least 1 dose of methoxy polyethylene glycol-epoetin beta or a comparator ESA) who had hemoglobin values available for analysis.||g/dL||Standard Deviation|Mean
174355|NCT00090610|Secondary|Median Overall Survival||Every 6 months starting at 12 months, to 24 months|||months||95% Confidence Interval|Median
174356|NCT00090610|Secondary|Recurrence-Free Survival|Recurrence-free survival is based on measurable disease using Kaplan-Meier estimates for the intent to treat (ITT) Population who achieved a complete response.|Every 6 months starting at 12 months, to 24 months|Subjects who had a complete response.||months||95% Confidence Interval|Median
174357|NCT00090610|Secondary|Quality of Life|"Quality of Life was measured using the Trial Outcome Index (TOI) score of the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) instrument, version 4. The TOI portion of the FACT-O included questions related to Physical well-being (PWB), Social/Family well-being (FWB), and an ovarian cancer specific module (OCS). The PWB score range is from 0-28; the FWB score range is from 0-28; the OCS score range is from 0-44; this gives the TOI a score range from 0-100. (TOI = PWB + FWB + OCS)~With these instruments, a higher score indicates better health-related quality of life."|Baseline performed 14 days before first dose, then every other cycle and at study termination|The number of participants was based on QoL data available for Arm 1 and one patient withdrew on Arm 2.||units on a scale||Standard Deviation|Mean
174358|NCT00090610|Secondary|Objective Response Rate|"Complete response rate plus partial response rate, where: Complete response (CR) is defined as disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart and normalization of elevated CA125 in cases of ovarian cancer; Partial response (PR) for measurable disease is defined >= 30% decrease in the sum of the longest dimensions of all target measurable lesions with no unequivocal progression of non-target lesions as well as no new lesions, with documentation by two disease assessments at least four weeks apart. PR according to CA125 levels is defined as a 50% decrease in CA125 levels where two initial samples were elevated and the sample that shows the 50% is confirmed by a fourth sample 28 days after the prior sample.~OR = CR + PR"|Every 6 months, starting at 12 months to 24 months|Same as for PFS||percentage of participants||95% Confidence Interval|Number
174359|NCT00090610|Primary|Progression-free Survival (PFS)|"Progression in measurable disease is defined as any of the following: At least a 20% increase in the sum of the longest diameter target lesions; appearance of one or more new lesions; Death due to disease without prior objective documentation of progression; deterioration in health status attributable to the disease requiring a change in therapy without objective documentation of progression~Progression in non-measurable disease according to CA125 levels is defined as any of the following: CA125 that begins in normal range increases to twice the upper limit of normal; CA125 level that begins elevated increases 25% over two previous samples, a 50% increase over three previous samples, or a persistent elevation over 100 U/ml for more than 2 months without a 50% decrease."|Every 6 months, to 18 months|1 patient in each arm was excluded. The patient in Arm 1 did not complete 1 cycle of therapy. A patient in Arm 2 withdrew from the study||months||95% Confidence Interval|Median
174360|NCT00090584|Secondary|Symptom Improvement|"Number of women who responded much better or better to question: Overall, do you feel that you are much better, better, about the same, worse or much worse?"|8 months|Participants who completed the perceived improvement item at 8 months.||participants|||Number
174371|NCT00090519|Primary|Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye|The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity.|Baseline, 36 Months|Intent-to-treat (ITT) population: all randomized participants with at least 1 eligible study eye analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||participants|||Number
174372|NCT00090519|Secondary|Number of Participants With Adverse Events|Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.|Baseline through 36 Months|Safety population: all randomized participants who received at least one dose of study drug.||participants|||Number
174373|NCT00090519|Secondary|Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months|25 vision-targeted questions representing 11 vision-related constructs and a 1-item general health rating question. Measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning and task-oriented domains related to daily visual functioning. Each item is converted to a 0 to 100 scale such that a higher score represents better functioning.|36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||units on a scale||Standard Deviation|Mean
174374|NCT00090519|Secondary|Change From Baseline at Endpoint in Albumin/Creatinine Ratio||36 Months|The completer population includes participants who completed all 36 months of the treatment phase.||micrograms/millimole (ug/mmol)||Standard Deviation|Mean
174375|NCT00090519|Secondary|Change From Baseline in Estimated Glomerular Filtration Rate|The Modification of Diet in Renal Disease (MDRD) study formula used for the estimated glomerular filtration rate (eGFR) determination is: eGFR = 170 X (Serum creatinine concentration [mg/deciliter (dL)])-0.999 X (Age [years]) -0.176 X (0.762 if participant is female) X (1.180 if participant is black) X (Serum urea nitrogen concentration [mg/dL])-0.170 X (Serum albumin concentration [grams (g)/dL])+0.318.|Baseline, 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||milliliter/minute/1.73 square meter||Standard Deviation|Mean
174376|NCT00090519|Secondary|Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography|Participants were classified as having experienced progression or no progression of DR by 36-month visit. Progression of DR=3 steps on ETDRS retinopathy severity person scale for participants with both eyes less than proliferative diabetic retinopathy (PDR) at baseline OR 2 steps on ETDRS retinopathy severity eye scale for participants with 1 eye less than PDR at baseline OR application of panretinal laser therapy. Participants were assigned at baseline to ETDRS retinopathy severity scale for persons or individual eyes; determination of no progression/progression was dependent on the scale.|Baseline through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||participants|||Number
174377|NCT00090519|Secondary|Change From Baseline in Contrast Sensitivity by Pelli-Robson|Pelli-Robson chart read from left to right + from top to bottom. Each line has 2 groups, each of 3 letters. Letters in each group have same contrast. Contrast in each successive group is less than the preceding group. Participant reads letters starting with highest contrast, continues until 2 or 3 letters in 1 group are incorrectly named. Scored on key showing all letters at full contrast, gives the log contrast sensitivity corresponding to each group. Score is determined by previous group (last group in which 2 or 3 letters were correctly named). Results reported based on number of DR eyes.|Baseline, 36 Months|Intent-to-treat (ITT) population: all randomized participants analyzed according to treatment group to which they were originally assigned by random allocation even if they did not take the assigned treatment, did not receive the correct treatment, or otherwise did not follow the protocol.||Letters read correctly|Participants|Standard Deviation|Mean
174378|NCT00090519|Secondary|First Occurrence of Focal/Grid Photocoagulation|The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.|Baseline through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||participants|||Number
174379|NCT00090519|Secondary|Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months|ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. Results are reported based on the number of diabetic retinopathy (DR) eyes.|Baseline, 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||Letters read correctly|Participants|Standard Deviation|Mean
174398|NCT00090259|Secondary|Number of Participants That Experienced One Components of the Composite Clinical Endpoint of All Cause Death or Cardiovascular Hospitalization|Cardiovascular hospitalization is defined as any hospitalization that may be attributed to a cardiovascular cause, including heart failure.|Entire follow-up (median = 4.7 years)|Intention-to-Treat||Participants|||Number
174380|NCT00090519|Primary|Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)|Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed.|6 Months through 36 Months|Intent-to-treat (ITT) population including all randomized participants analyzed according to the treatment group to which they were originally assigned by random allocation even if the participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.||months per participant||Standard Deviation|Mean
174381|NCT00090493|Primary|The Number of Participants Experiencing a Response to the Peptide Vaccines.|The peptides are fragments from two proteins MAGE-A3 and NY-ESO-1. There will be a series of 12 peptide vaccinations given as a subcutaneous (beneath the skin) injection (vaccines) at 2 week intervals resulting in an immune response to myeloma. The tumor peptides used in the vaccines are unique to myeloma, and it is not expected that there will be an immune response to normal organs. Myeloma cells must express MAGE-A3 or NY-ESO-1, be severe enough to require chemotherapy and stem cell transplantation and have appropriate HLA tissue type.|2 week intervals|only 2 were complete per protocol. 2 were withdrawn by physician due to relapse.||participants|||Number
174382|NCT00090402|Secondary|Activities of Daily Living||baseline, 6 months, 12 months||01/2010||||
174383|NCT00090402|Primary|F2-isoprostane Level Urine F2-Isoprostanes Were Collected.|F2-isoprostane, this biomarker was used as an indicator for detecting peripheral oxidative damage (oxidative damage in lipids).|12 months|ITT||nanogram per miligram||Standard Error|Mean
174384|NCT00090363|Secondary|Change in Number of Bone Metastases Over Time|Percentage change in the number of bone metastases from baseline to last available post-baseline scan prior to discontinuation.|Baseline to last available post-baseline scan prior to discontinuation, up to maximum of 1164 days.|||Percentage Change||Standard Deviation|Mean
174385|NCT00090363|Secondary|Objective Response Rate (ORR)|Using the Response Evaluation Criteria in Solid Tumours (RECIST), an objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR), which is subsequently confirmed as per RECIST. Objective Response Rate (ORR) is defined as the percentage of patients with OR.|For patients with measurable disease at baseline, Response Evaluation Criteria in Solid Tumours (RECIST) scans were 12-weekly from randomisation. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).|Only patients with measurable disease at the baseline were included in the analysis.||percentage of participants|||Number
174386|NCT00090363|Secondary|Change in Total Prostate Specific Antigen (PSA) Over Time|Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to 12 weeks.|Baseline to 12 weeks. 'Initial analysis' results are given - the most recent formal analysis (data cut-off 10th April 2006).|The analysis population only includes patients with baseline and Week 12 PSA measurements||Percentage Change in PSA||Standard Deviation|Mean
174387|NCT00090363|Secondary|Time to Death|Median time (in days) from randomisation until death using the Kaplan-Meier method.|Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. After progression survival was assessed 6-monthly. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).|||Days||Inter-Quartile Range|Median
174388|NCT00090363|Primary|Time to Progression (TTP)|Median time (in days) from randomisation until disease progression, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline or death using the Kaplan-Meier method.|Follow-up for progression/death was 4-weekly for 2 years after first dose and 3-monthly thereafter. 'Final analysis' results are given - the most recent formal analysis (data cut-off 18th December 2008).|||Days||Inter-Quartile Range|Median
174389|NCT00090285|Primary|Number of Participants With Vaccine-Related Serious Adverse Events (SAEs)||Base study: through Month 36|All participants receiving at least 1 vaccination with qHPV vaccine or placebo in the base study||participants|||Number
174390|NCT00090285|Primary|Number of Participants With Severe Injection Site Adverse Experiences (AEs)||Base study: through Day 5 after any vaccination|All participants receiving at least 1 vaccination with qHPV vaccine or placebo in the base study||participants|||Number
174391|NCT00090285|Other Pre-specified|Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM)|Participants with HPV 6/11/16/18-related AIN or anal cancer per 100 person-years of follow-up|Base study: through Month 36|Only a subset of the enrolled population was used for the analysis of this substudy. Per-protocol participants that were naïve to the relevant vaccine HPV types at enrollment and remained PCR negative to the relevant types through the vaccination period, including the Month 7 visit were analyzed.||Incidence per 100 person-years|||Number
174392|NCT00090285|Secondary|Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection|Subjects with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up.|Base study: through Month 36|"Per-protocol population: subjects must~have no major protocol violations, must be seronegative to the relevant HPV type at Day 1 and PCR negative to~the relevant HPV type Day 1 through Month 7, and must provide follow-up data after Month 7."||Detection per 100 person-years|||Number
174393|NCT00090285|Secondary|Incidence of HPV 6/11/16/18-related Persistent Infection|Subjects with HPV 6/11/16/18-related persistent infection per 100 person-years of follow-up.|Base study: through Month 36|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and must provide follow-up data after Month 7.||Infection per 100 person-years|||Number
174394|NCT00090285|Primary|Incidence of Human Papillomavirus (HPV) Related External Genital Warts, Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer|Subjects with HPV 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer per 100 person-years of follow-up.|Base study: through Month 36|Per-protocol population: subjects must have no major protocol violations, must be seronegative to the relevant HPV type at Day 1 and polymerase chain reaction (PCR) negative to the relevant HPV type Day 1 through Month 7, and must provide follow-up data after Month 7.||Incidence per 100 person-years|||Number
174400|NCT00090233|Secondary|Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F|Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Serum antibody titers to type-specific pneumococcal polysaccharides were determined by an EIA.|42 days following third dose|Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.||micrograms/mL||95% Confidence Interval|Geometric Mean
174401|NCT00090233|Secondary|Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin|Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin. Antibody titers were measured with an indirect, non-competitive, enzyme immunoassay (EIA).|42 days following third dose|Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.||ELISA units/mL||95% Confidence Interval|Geometric Mean
174402|NCT00090233|Secondary|Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo|The number of participants who achieved seroprotection/seroconversion to hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, & polio types 1, 2, & 3, per established criteria.|42 days following third dose|Per Protocol Population||Participants|||Number
174403|NCT00090233|Secondary|Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose|Number of participants with rotavirus gastroenteritis whose clinical score was >16 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms [range: total score 0 (best) to 24 (worst)].|At least 14 days following the 3rd vaccination through the first rotavirus season|Per Protocol Population Using Per-Protocol Case Definition||Participants|||Number
174404|NCT00090233|Secondary|Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.|Number of participants with rotavirus gastroenteritis whose clinical score was >8 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms [range: total score 0 (best) to 24 (worst)].|At least 14 days following the 3rd vaccination through the first rotavirus season|Per Protocol Population Using Per-Protocol Case Definition||Participants|||Number
174405|NCT00090233|Secondary|Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4|Health Outcomes Substudy – Occurrence of hospital admissions and emergency department visits for episode(s) of rotavirus gastroenteritis associated with serotypes G1, G2, G3, or G4 by treatment group. Occurrence was expressed as the annual number of events per 1000 person-years.|At least 14 days following the 3rd vaccination|Per Protocol Population Using Per-Protocol Case Definition||Annual # of events per 1000 person-years|||Number
174406|NCT00090233|Primary|Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination|Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.|At least 14 days following the 3rd vaccination through the first full rotavirus season|Per Protocol Population Using Per-Protocol Case Definition||Participants|||Number
174407|NCT00090233|Secondary|G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus|Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3.|14 days following the 3rd vaccination|Per Protocol Population among participants in Finland using Per-Protocol Case Definition||Participants|||Number
174408|NCT00090233|Primary|Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo|Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.|Within 42 days following any dose of RotaTeq™/placebo|All participants in the study were followed for potential cases of intussusception.||Participants|||Number
174409|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 6 to 10|The four HPV types were determined by PCR testing.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
174410|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Year 4 to 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
174411|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18-related CIN 2 or Worse (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Incidence per 100 person-years||95% Confidence Interval|Number
174651|NCT00089141|Secondary|Open Label Systemic Treatment Because of Inadequate Response to Primary Therapy|Administration of any systemic therapy other than the immunosuppressive agents used for initial treatment, because of persistent or progressive chronic graft-versus-host disease|2 years|||participants|||Number
174412|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 6 to 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
174413|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Year 4 to 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
174414|NCT00090220|Other Pre-specified|Cumulative Incidence of HPV 16/18-related CIN 2 or Worse: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Cumulative Incidence Probability||95% Confidence Interval|Number
174415|NCT00090220|Other Pre-specified|Incidence Rate of HPV 16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|HPV 16/18: The two types of HPV (types 16/18) were determined by PCR testing|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7||Incidence per 100 person-years|||Number
174416|NCT00090220|Secondary|Incidence Rate of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|This outcome measure was not analyzed because of diminished interest by experts in composite efficacy endpoints associated with these HPV types|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)||||||
174417|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 6 to Year 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
174418|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Year 4 to Year 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
174419|NCT00090220|Secondary|Incidence Rate of HPV 6/11-related Condyloma (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Incidence per 100 person-years||95% Confidence Interval|Number
174420|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Year 6 to Year 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10 conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
174421|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Year 4 to Year 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8 conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
174422|NCT00090220|Secondary|Cumulative Incidence of HPV 6/11-related Condyloma: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4 conditional on having been event-free at Day 1.|Up to 48 months (4 years) after the first dose of qHPV vaccine or placebo in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Cumulative Incidence Probability||95% Confidence Interval|Number
174423|NCT00090220|Secondary|Incidence Rate of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|HPV 6/11: The two types of HPV (types 6/11) were determined by PCR testing|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7||Incidence per 100 person-years|||Number
174424|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 114 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
174425|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 90 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 96 (96 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
174426|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 66 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
174427|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 42 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
174428|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 30 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
174429|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 18 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
174457|NCT00090142|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
174430|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 6 Months Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
174431|NCT00090220|Primary|Percentage of Participants Seropositive for Anti-HPV Antibody at 1 Month Postdose 3 in the Base Study|Serum antibodies to HPV Types 6, 11, 16, and 18 were determined by Competitive Luminex Immunoassay (cLIA). The seropositive thresholds (in mMU/mL) were >20 for Type 6, >16 for Type 11, >20 for Type 16, and >24 for Type 18. This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||Percentage of participants||95% Confidence Interval|Number
174432|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 114 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 120 (114 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
174433|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 90 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 96 (90 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
174434|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 66 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 72 (66 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
174435|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 42 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 48 (42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
174436|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 30 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 36 (30 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
174437|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 18 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 24 (18 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
174458|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose||0-90 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Participants|||Number
174438|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 6 Months Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 12 (6 months after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
174439|NCT00090220|Primary|Geometric Mean Titer for Anti-HPV Type 6, 11, 16, and 18 Antibody at 1 Month Postdose 3 in the Base Study|Serum antibodies to the HPV Types were determined by Competitive Luminex Immunoassay (cLIA). Geometric Mean Titers (GMT) are reported in milli-Merck Units/mL (mMU/mL). This Outcome Measure evaluated age-specific immunogenicity responses, and applied only to participants who received qHPV in the Base Study.|Month 7 (1 month after the third dose of qHPV vaccine in the Base Study)|Participants who received ≥1 qHPV vaccination. n = participants who were seronegative to the HPV type on Day 1 and PCR negative to the HPV type through Month 7, received 3 doses of qHPV, had a valid postdose 3 serology result for the HPV type, and did not fail any exclusion criteria pertinent to immunogenicity.||mMU/mL||95% Confidence Interval|Geometric Mean
174440|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 6 to 10|The four HPV types were determined by PCR testing.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
174441|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Year 4 to 8|The four HPV types were determined by PCR testing. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Incidence per 100 person-years||95% Confidence Interval|Number
174442|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18-related CIN or Condyloma (Secondary Analysis): Day 1 to Year 4|The four HPV types were determined by PCR testing.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Incidence per 100 person-years||95% Confidence Interval|Number
174443|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 6 to 10|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 6 to Year 10, conditional on having been event-free from Day 1 to Year 6.|From 72 to 120 months (6 to 10 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 6. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
174444|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related CIN or Condyloma: Year 4 to 8|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Year 4 to Year 8, conditional on having been event-free from Day 1 to Year 4. The analysis windows were cut at the exact time points, e.g., Year 4. Visits and events which occurred after Year 4 due to visit window or follow-up investigations are included in the Year 4 to Year 8 time interval.|From 48 to 96 months (4 to 8 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data after Year 4. This Outcome Measure applied only to participants who received qHPV in the Base Study.||Cumulative Incidence Probability||95% Confidence Interval|Number
174445|NCT00090220|Primary|Cumulative Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN) or Condyloma: Day 1 to Year 4|The four HPV types were determined by PCR testing. Cumulative incidence probability is the probability of becoming an endpoint case at any time from Day 1 to Year 4, conditional on having been event-free at Day 1.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the HPV types at Day 1 and PCR negative to the HPV types through Month 7, and provided follow-up data.||Cumulative Incidence Probability||95% Confidence Interval|Number
174446|NCT00090220|Primary|Number of Participants With an SAE Resulting in Death After Vaccine Administration|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose.|qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120|Participants who received >=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up||Participants|||Number
174459|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose||0-90 minutes after the exercise challenge performed at 12 hours postdose|"The secondary efficacy analysis used a modified~intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis."||Participants|||Number
174447|NCT00090220|Primary|Number of Participants With Vaccine-Related SAEs After Vaccine Administration|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.|qHPV in Base Study: Up to Month 120; Placebo in Base Study: approximately Month 60 up to Month 120|Participants who received >=1 qHPV vaccination in the Base Study or EXT1 and had safety follow-up||Participants|||Number
174448|NCT00090220|Primary|Number of Participants With Vaccine- or Placebo-Related Serious Adverse Events (SAEs) in the Base Study|An adverse event (AE) is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is a cancer, or is an overdose. Vaccine-related SAEs are those deemed by the investigator to be definitely, probably, or possibly related to study vaccine.|Up to Month 48 (up to 42 months after the third dose of qHPV vaccine in the Base Study)|Participants who received >=1 qHPV vaccination or placebo injection in the Base Study and had safety follow-up||Participants|||Number
174449|NCT00090220|Primary|Incidence Rate of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer|The four HPV types were determined by polymerase chain reaction (PCR) testing. VIN = vulvar intraepithelial neoplasia; VaIN = vaginal intraepithelial neoplasia; AIS = adenocarcinoma in situ.|Up to 48 months (4 years) after the first dose of qHPV vaccine in the Base Study|Participants who had no major protocol violations, received all 3 vaccinations, were seronegative to the relevant HPV type at Day 1 and PCR negative to the relevant HPV type Day 1 through Month 7, and provided follow-up data after Month 7||Incidence per 100 person-years|||Number
174450|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 24 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
174451|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 12 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
174452|NCT00090142|Secondary|Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose|The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.|Exercise challenge at 2 hours postdose|The secondary efficacy analysis used a modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Minutes||Standard Deviation|Mean
174453|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose|The secondary efficacy analysis was an MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
174454|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 12 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
174455|NCT00090142|Secondary|Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose|The measure included only the area below the pre-exercise baseline.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose|The secondary efficacy analysis used a MITT approach. If a patient received β-agonist rescue medication during the 60 minutes following exercise challenge, then the last pre-rescue FEV1 measurement was carried forward to 60 minutes. Patients with data from only one period were not included in the analysis.||(percent change) *minutes||Standard Deviation|Mean
174456|NCT00090142|Secondary|Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
174460|NCT00090142|Secondary|Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose||0-90 minutes after the exercise challenge performed at 2 hours postdose|"The secondary efficacy analysis used a modified~intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis."||Participants|||Number
174461|NCT00090142|Primary|Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)|In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge.|Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose|The primary efficacy analysis used the modified intention-to-treat (MITT) approach. Patients with data from only one period were not included in the analysis.||Percent Change||Standard Deviation|Mean
174462|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 12 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Would you ask your doctor for the medication you received in this study?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174463|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 11 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Overall, how satisfied are you with the study medication and it's effect on your urinary problems?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174464|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 10 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your ability to go about your usual activities without interference from your urinary problems?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174465|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 9 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the way your urinary problems interfere with your ability to go about your usual activities changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174466|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 8 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain during urination?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174467|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 7 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain during urination changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174468|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 6 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect the study medication has on your pain prior to urinating?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174518|NCT00089843|Secondary|Markers of Bone Metabolism|type 1 collagen C-telopeptide(CTX); The differences in log-transformed values are reported as percent change.|Baseline to 12 months|1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.||percent change of CTX||95% Confidence Interval|Mean
174469|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 5 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has your pain prior to urinating changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174470|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 4 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on the strength of your urinary stream?. Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174471|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 3 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has the strength of your urinary stream changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174472|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 2 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of How satisfied are you with the effect of the study medication on control of your urinary problems? Satisfact., satisfaction."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174473|NCT00090103|Secondary|Patient Perception of Study Medication (PPSM): Number of Participants With the Indicated Responses to Question 1 (LOCF)|"This 12-item questionnaire (PPSM) was developed by GlaxoSmithKline for use in this study and was designed to quantify the participant's perceptions and satisfaction with the effect of study treatment on control of their urinary symptoms at baseline and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, and 48. Participants were asked to respond to the question of Since you began taking the study medication, how has control of your urinary problems changed?."|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Only participants responding to the question were analyzed.||participants|||Number
174474|NCT00090103|Secondary|Adjusted Mean Change From Baseline in BPH-Related Health Status (BHS) at Months 12, 24, 36, and 48|The effect of study treatment on BHS was assessed by using three self-administered questionnaires: the International Prostate Symptom Score (IPSS), the BPH Impact Index (BII), and Patient Perception of Study Medication (PPSM). The BHS score was collected on the IPPS questionnaire and ranged from 0 (best) to 6 (worst). Percent change from baseline = [(post-baseline – baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: change from baseline BPH-related health status = treatment + cluster + baseline BPH-Related health status.|Baseline and Months 12, 24, 36, 48|ITT Population. As the study progressed, participants dropped out of the study.||points on a scale||Standard Error|Least Squares Mean
174475|NCT00090103|Secondary|Adjusted Mean Change From Baseline in BPH Impact Index (BII) at Months 12, 24, 36, and 48|The BII is a 4-item questionnaire, score range of 0 (best) to 12 (worst) for questions 1-3, and 0 (best) to 13 (worst) for question 4, that assesses the overall impact of BPH on a participant's general sense of well being and measures aspects of physical discomfort, worry, and bother, all of which can be affected by BPH and its symptoms. BII score = sum of questions 1-4. Change from baseline = Post-Baseline Value. Estimates are based on the adjusted (least squares) means from the general linear model: change from baseline BII = treatment + cluster + baseline BII.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study.||points on a scale||Standard Error|Least Squares Mean
174476|NCT00090103|Secondary|Number of Unscheduled Visits to GP/Urologist (Outpatient) Planned, Not Relating to the Study (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Does the participant have any unscheduled GP/Urologist (outpatients) visits planned, not relating to the study (this can include visits resulting from UTI, UI, macroscopic haematuria, etc.?. If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out the study.||visits|||Number
174477|NCT00090103|Secondary|Number of Unplanned Visits to GP/Urologist That Would Have Taken Place if a Scheduled Study Visit Had Not Been Planned (Including Visits Resulting From UTI, UI, Macroscopic Haematuria, Etc.)|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with unplanned visits to GP/Urologist. Responses to the following question were recorded: Has the participant had any unplanned GP/Urologist (outpatient) visits that would have taken place if a scheduled study visit had not been planned (this can include visits resulting from UTI, UI macroscopic haematuria, etc?. If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out of the study.||visits|||Number
174478|NCT00090103|Secondary|"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit?"|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Would the participant have paid a visit to his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was “yes,” the number of Yes responses was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As study progressed, participants dropped out of study.||yes responses|||Number
174479|NCT00090103|Secondary|Number of Visits to GP/Urologist Regarding BPH-related Surgery Since the Last Study Visit|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with BPH-related surgery. Responses to the following question were recorded: Has the participant needed to visit his general practitioner (GP)/Urologist regarding BPH-related surgery since the last study visit?. If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.||visits|||Number
174480|NCT00090103|Secondary|"Number of Yes Responses to the Question: Would the Participant Have Paid a Visit to His GP/Urologist Regarding AUR Symptoms if the Study Visit Had Not Been Planned?."|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Would the participant have paid a visit to his GP/Urologist regarding AUR symptoms if this study visit had not been planned?. If the answer to the question was “yes,” the number of Yes responses was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.||yes responses|||Number
174481|NCT00090103|Secondary|Number of Unscheduled Visits to GP/Urologist Regarding AUR Symptoms Since the Last Study Visit|"At each scheduled 13-week clinic visit post-randomization, the investigator was to record details of any health care utilization associated with an episode of AUR. Responses to the following question were recorded: Has the participant needed to make any unscheduled visits to his general practitioner (GP)/Urologist regarding AUR symptoms since the last study visit? If the answer to the question was “yes,” the number of visits was recorded."|Every 3 months from Month 3 to Month 48|ITT Population. As the study progressed, participants dropped out of the study.||visits|||Number
174482|NCT00090103|Secondary|Adjusted Mean Change From Baseline in Transition Zone (Portion of the Prostate That Surrounds the Proximal Urethra) Volume at Months 12, 24, 36, and 48|Prostate volume (PV) measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total PV in centimeters (cc). Results are for the transition zone measurements of the prostate in a small subset of participants. Percent change from baseline (BL) = [(post-BL - BL)/BL value] x 100. Estimates are based on the adjusted (least squares) means for the general linear model: log(post-BL/BL value) = treatment + cluster + log(BL value) and are reported as percent change from BL.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Transition zone measurements were only done on a subset of participants at sites with experience in measuring the transition zone of the prostate. Also, transition zone measurements were either not performed or missing for some participants at various timepoints.||percent change||Standard Error|Least Squares Mean
174483|NCT00090103|Secondary|Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48|Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = [(post-baseline - baseline)/baseline value] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Also, prostate measurements were either not performed or missing for some participants at various timepoints.||percent change||Standard Error|Least Squares Mean
174484|NCT00090103|Secondary|Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48|Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study. Also, assessments with voided volumes <125 ml were not included in the analysis.||milliliters (mL)/second (sec)||Standard Error|Least Squares Mean
174485|NCT00090103|Secondary|Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48|The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS.|Baseline and Months 12, 24, 36, and 48|ITT Population. As the study progressed, participants dropped out of the study.||points on a scale||Standard Error|Least Squares Mean
174486|NCT00090103|Secondary|Number of Participants With an Event of Post-baseline BPH-related Hematospermia|A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories.|Baseline (Day 1) through Year 4|ITT Population||participants|||Number
174652|NCT00089141|Secondary|Definitive Absence of Efficacy Success|Administration of secondary systemic therapy for chronic GVHD, death during primary therapy, or onset of recurrent malignancy or bronchiolitis obliterans during primary therapy|2 years|||participants|||Number
174487|NCT00090103|Secondary|Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria|A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories.|Baseline (Day 1) through Year 4|ITT Population||participants|||Number
174488|NCT00090103|Secondary|Number of Events of Symptom Deterioration at the Indicated Time Periods|The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35).|Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit)|Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.||events|||Number
174489|NCT00090103|Secondary|The Number of Participants With Each of the Five Components of BPH Clinical Progression|The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency.|Baseline (Day 1) to Year 4|ITT Population||participants|||Number
174490|NCT00090103|Primary|Number of Participants With AUR or BPH-related Surgery|A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record.|Baseline (Day 1) through Year 4|ITT Population||participants|||Number
174491|NCT00090103|Secondary|Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4|The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond.|Years 1, 2, 3, and 4|ITT Population. As the study progressed, participants dropped out of the study.||events|||Number
174492|NCT00090103|Primary|Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods.|A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record.|Years 1, 2, 3, and 4|Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study.||events|||Number
174493|NCT00090051|Secondary|Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment|Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population,all randomized participants, who started a new treatment for CLL or died.||Days||95% Confidence Interval|Median
174494|NCT00090051|Secondary|Final Analysis: Duration of Response|Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, with complete or partial response.||Days||95% Confidence Interval|Median
174495|NCT00090051|Secondary|Final Analysis: Time to Disease-Free Survival Event|Time to disease-free survival (DFS) event was defined as the time from first documented response until the first documented DFS event: disease progression, relapse or death from any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, with complete response. .||Days||95% Confidence Interval|Median
174496|NCT00090051|Secondary|Final Analysis: Percentage of Participants With Complete Response|Complete response was defined as the disappearance of all signs of cancer in response to treatment.|Median observation time was approximately 5 years|Intent-to-treat population included all randomized participants.||Percentage of participants|||Number
174497|NCT00090051|Secondary|Final Analysis: Time to Event-Free Survival Event|Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, who had an EFS event. Participants who did not have an ESF event at the time of the final analysis were censored at the date of the last contact.||Days||95% Confidence Interval|Median
174498|NCT00090051|Secondary|Final Analysis: Time to Overall Survival Event|Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause.|Median observation time was approximately 5 years|The analysis included only those participants from the Intent-to-treat population,all randomized participants, who died. Participants who had not died at the time of the final analysis were censored at the date of the last contact.||Days||95% Confidence Interval|Median
174499|NCT00090051|Primary|Final Analysis: Time to Progression-Free Survival Event|Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first.|Median observation time was approximately 5 years|Participants from the Intent-to-treat population, all randomized participants, who experienced a PFS event. Participants who did not have a PFS event at the time of the final analysis were censored at the date of the last contact.||Days||95% Confidence Interval|Median
174531|NCT00089674|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174500|NCT00090051|Secondary|Number of Participants With Disease-free Survival (DFS) Events|Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population with a Best Overall Response of Complete Response.||participants|||Number
174501|NCT00090051|Secondary|Disease-free Survival (DFS)|Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population for patients with a Best Overall Response of Complete Response.||Days||95% Confidence Interval|Median
174502|NCT00090051|Primary|Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)|Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||participants|||Number
174503|NCT00090051|Secondary|Number of Participants With Event-free Survival (EFS) Events|Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||participants|||Number
174504|NCT00090051|Secondary|Event-free Survival (EFS)|Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||Days||95% Confidence Interval|Median
174505|NCT00090051|Secondary|Number of Participants With Overall Survival (OS) Events|Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||participants|||Number
174506|NCT00090051|Secondary|Overall Survival (OS)|Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||Days||95% Confidence Interval|Median
174507|NCT00090051|Primary|Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)|Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.|Mean observation time at time of analysis was approximately 26 months|Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.||Days||95% Confidence Interval|Median
174508|NCT00089999|Secondary|Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)|An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. Refer to the general AE/SAE module for a list of non-serious AEs and SAEs.|From the date of the first dose of investigational product until 30 days after the last dose of investigational product (up to study week 192)|Safety Population: all randomized participants who received at least one dose of investigational product.||Participants|||Number
174509|NCT00089999|Secondary|Time to Treatment Failure, as Assessed by IRC and Investigator|Time to treatment failure is calculated as the interval between the date of randomization and the occurrence of local tumor progression (including ipsilateral [on the same side] and controlateral breast tumor progression), distant tumor progression, permanent treatment discontinuation (either for the experimental or conventional treatment arm), or death due any cause. For participants who did not progress, die or discontinue early, time to treatment failure was censored at the last scan date.|From randomization until the first documented sign of disease progression, death due to any cause, or early discontinuation from investigational product (up to Study Week 103)|ITT Population||Weeks||95% Confidence Interval|Median
174510|NCT00089999|Secondary|Progression-free Survival, as Assessed by the IRC and Investigator|Progression-free survival is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. Disease progression was based on the IRC's and investigator's assessments of the objective evidence (e.g., radiological scans and medical photographs). For participants who did not progress, or die, progression-free survival was censored at the time of the last IRC assessed radiological scan.|From the date of the first dose of investigational product until the earlier of the date of disease progression or death due to any cause (up to Study Week 103)|ITT Population||Weeks||95% Confidence Interval|Median
174511|NCT00089999|Secondary|Duration of Response (DoR), as Assessed by the IRC and Investigator|DoR is defined for the subset of par. who had a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of >= 1 non-TL[s]) as the time from the first documented evidence of a CR or PR until the first documentation of radiological PD or death due to breast cancer, if sooner. PD is defined as >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. For par. who did not progress or die, DoR was censored on the date of the last radiological scan. If a par.had only a Baseline visit or did not have a date of a radiological scan that was later than the date of initiation of anti-cancer therapy, DoR was censored at the start date of treatment.|From the first documented evidence of a PR or CR until the earlier of the date of disease progression or the date of death due to breast cancer (up to Study Week 103)|ITT Population. Only those participants with CR or PR were analyzed (represented by n=X in the category titles). Different participants may have been analyzed by the IRC and the Investigator, so the overall number of participants analyzed reflects everyone in the ITT Population.||Weeks||Inter-Quartile Range|Median
174512|NCT00089999|Secondary|Time to Response, as Assessed by the IRC and Investigator|Time to response is defined as the time from randomization until the first documented evidence of a PR or CR (whichever status is recorded first). Analysis was based on responses confirmed at a repeat assessment made at least 4 weeks after the initial response, with the time to response taken as the first time the response was observed, not the confirmation assessment. Participants who withdraw with no tumor response were censored at the date of withdrawal from the study. CR is defined as the disappearance of all TLs and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s). PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions or unequivocal progression of existing non-TLs.|From the date of the first dose of investigational product until the first documented evidence of a PR or CR (up to Study Week 103)|ITT Population. Only those participants with CR or PR were analyzed (represented by n=X in the category titles). Different participants may have been analyzed by the IRC and the Investigator, so the overall number of participants analyzed reflects everyone in the ITT Population.||Weeks||Full Range|Median
174513|NCT00089999|Secondary|Percentage of Participants With Clinical Benefit (CR or PR or Stable Disease [SD] for at Least 24 Weeks), as Assessed by the IRC and Investigator|Clinical benefit is defined as the numer of participants achieving either a confirmed CR (disappearance of all target lesions (TLs) and non-TLs) or PR (at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD,or complete resolution of TLs and the persistence of one or more non-TLs)or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [at least a 20% increase in the sum of the LD of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of 1 or more new TLs or non-TLs and/or unequivocal progressionn of existing non-target lesions], taking as reference, the smallest sum LD since the treatment started) for at least 24 weeks. This was based on confirmed responses from the investigator assessment of clinical benefit.|From the date of the first dose of investigational product until the date of disease progression or death due to breast cancer (up to Study Week 103)|ITT Population||Percentage of Participants|||Number
174514|NCT00089999|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Investigator|OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)|ITT Population||Participants|||Number
174515|NCT00089999|Primary|Number of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR), as Assessed by the Independent Review Committee (IRC)|OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete resolution of TLs and the persistence of one or more non-TL(s), as assessed by the IRC. PD is defined as at least a 20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions or unequivocal progression of existing non-TLs. Responses were confirmed at subsequent assessments made >=28 days after the original response. Participants with an unknown or missing response are treated as non-responders.|From the date of the first dose of investigational product to the first documented evidence of a confirmed CR or PR (up to Study Week 103)|Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of investigational product.||Participants|||Number
174516|NCT00089895|Secondary|Incidence of the Composite of Death/MI.||30 days after randomization|Intent to treat population||percentage of participants|||Number
174517|NCT00089895|Primary|Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.||96 hours after randomization|Intent to treat population||percentage of participants|||Number
174519|NCT00089843|Primary|Bone Mineral Density|Percent change in postero-anterior (PA) spine bone mineral density as measured by dual energy x-ray absorptiometry (DXA)over a 12-month period. The differences in log-transformed values are reported as percent change.|Baseline and 12 months|1 subject was excluded from analysis. A factorial analysis was performed and determines the effect of each intervention separately, whether or not a subject received the 2nd intervention. Therefore, data from all 76 subjects who participated were used to determine the effect of each intervention on our endpoints.||percent change||95% Confidence Interval|Mean
174520|NCT00089791|Secondary|Number of Participants With a Hip Fracture|Hip fractures are a subset of nonvertebral fractures including femur neck, femur intertrochanter, and femur subtrochanter.|36 months|Full analysis set||Participants|||Number
174521|NCT00089791|Secondary|Number of Participants With Nonvertebral Fractures|Nonvertebral fractures (osteoporotic) were those occurring on study excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges. Fractures associated with high trauma severity (fractures that were the result of a fall from higher than the height of a stool, chair, first rung on a ladder or equivalent (> 20 inches) or was the result of severe trauma other than a fall) and pathologic fractures were excluded from this category. Nonvertebral fractures were required to be confirmed either by radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI), or by documentation in a radiology report, surgical report, or discharge summary.|36 months|Full analysis set (all randomized participants)||Participants|||Number
174522|NCT00089791|Primary|Number of Participants With New Vertebral Fractures|A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms [or both] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture).|36 months|Primary Efficacy Analysis Set, which includes all randomized participants who have a baseline and ≥ 1 postbaseline evaluation of vertebral fracture at or before 3 years. Last Observation Carried Forward was used.||Participants|||Number
174523|NCT00089778|Primary|Immunologic Response to Peptide Vaccination Pre and Post Vaccination|FGF-5 specific CTL (cytotoxic T lymphocytes) may be tested by cytokine release assay or ELISPOT (enzyme linked immunosorbent spot) assay using tumor, FGF-5 transfected or peptide-loaded target cells and compared to pre-treatment peripheral blood mononuclear cells (PBMC) to determine immune response to vaccination. In the assays, differences of 2-3 fold are indicative of true biologic difference.Due to text data entry field limitations, Pre vaccination and post vaccination will be shown in the results as Pre V and Post V, respectively. Patients entered in Group A did not complete sufficient vaccinations to permit immunological evaluation and in Group B, the co-administration of IL-2 is known to corrupt immunological evaluation (so only clinical responses are valid). Expanding information on cancer vaccines in general as wells as preliminary information from this trial on FGF-5 as a vaccine target both served to render the enrollment of additional patients to this trial obsolete.|24 hours|“1 uM A3 culture vs tranfectant” means “Immune cells cultured with the concentration of 1 uM of the A3 peptide were tested against [with] target cells into which the FGF-5 target gene was inserted [transfected with] and the release of interferon is measured to detect immune recognition”.Documentation was only available for the 4 patients.||pg/ml/24 hrs|||Number
174524|NCT00089778|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|47 months|||Participants|||Number
174525|NCT00089778|Primary|Response Rate|Overall response is defined as the best response (e.g. complete response...) recorded from the start of treatment until disease progression/recurrence. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease is at least a 20% increase in the sum of LD of target lesions since the treatment started or the appearance of new lesion. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.|3 years and 9 months|Pts in Group C had no evaluable disease,response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B).||Participants|||Number
174526|NCT00089674|Secondary|Number of Participants With Any Fracture Through Month 24|Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.|24 months|Full analysis set||Participants|||Number
174527|NCT00089674|Secondary|Time to First Clinical Fracture Through Month 36|A clinical fracture was defined as any nonvertebral fracture or clinically evident fracture at the cervical vertebrae, thoracic vertebrae, and lumbar vertebrae that was associated with signs and/or symptoms indicative of a fracture. Fractures associated with high trauma severity and pathologic (ie, metastatic) fractures were excluded. Since the median time was not reached, time to first clinical fracture is represented by the Kaplan-Meier estimate of the percentage of participants with a clinical fracture.|36 months|Full analysis set||Percentage of participants|||Number
174528|NCT00089674|Secondary|Number of Participants With a New Vertebral Fracture Through Month 36|New Vertebral Fracture Assessed by Lateral Spine X-ray using Genant Semiquantitative Scoring Method excluding any symptomatic new vertebral fracture associated with high trauma severity or a pathologic fracture.|36 months|All randomized subjects who have a baseline and >= 1 postbaseline evaluation of vertebral fracture at or before 3 years.||Participants|||Number
174529|NCT00089674|Secondary|Number of Participants With Any Fracture Through Month 36|Any fracture includes osteroporotic fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges.|36 months|Full analysis set||Participants|||Number
174530|NCT00089674|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174532|NCT00089674|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36 Assessed by Dual Energy X-Ray Absorptiometry.|36 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 36. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174533|NCT00089674|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174534|NCT00089674|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174535|NCT00089674|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Lumbar Spine Bone Mineral Density Percent Chnage From Baseline at Month 24 Assessed by Dual Energy X-Ray Absorptiometry.|24 months|Randomized subjects who had a nonmissing baseline and >= 1 nonmissing postbaseline data before or at month 24. LOCF used as imputation method.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174536|NCT00089661|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174537|NCT00089661|Secondary|Femoral Neck Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174538|NCT00089661|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174539|NCT00089661|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174540|NCT00089661|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 6|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|6 months|||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174541|NCT00089661|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.|12 months|Subjects with non-missing baseline and >= 1 non-missing post-baseline evaluation. Using Last Observation Carried Forward as imputation.||Percent Change from Baseline||95% Confidence Interval|Least Squares Mean
174542|NCT00089648|Secondary|Plasma Concentration of Soluble VEGF Receptor-2(sVEGFR-2)|Plasma concentrations of sVEGFR-2 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were to have been analyzed by ELISA analysis; however, no data were collected.|1 year|||pg/mL||Full Range|Mean
174543|NCT00089648|Secondary|Plasma Concentration of VEGF-C|Plasma concentrations of VEGF-C that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28)|ITT||pg/mL||Full Range|Mean
174544|NCT00089648|Secondary|Plasma Concentration of Placental Growth Factor (PlGF)|Plasma concentrations of PlGF that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28)|ITT||pg/mL||Full Range|Mean
174545|NCT00089648|Secondary|Plasma Concentration of Soluble VEGF Receptor-3 (sVEGFR-3)|Plasma concentrations of sVEGFR-3 that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)|ITT||pg/mL||Full Range|Mean
174546|NCT00089648|Secondary|Plasma Concentration of Vascular Endothelial Growth Factor-A (VEGF-A)|Plasma concentrations of VEGF-A that may be associated with tumor proliferation or angiogenesis collected from a subset of subjects were analyzed by ELISA analysis. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Cycle 1 (Days 1, 14, and 28), Cycle 2 (Day 1)|ITT||pg/mL||Full Range|Mean
174547|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of Total Drug (Sunitinib + SU012662)||Day 28 of Cycle 1 to Cycle 4|ITT||ng/mL||Full Range|Median
174548|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of SU012662||Day 28 of Cycle 1 to Cycle 4|ITT||ng/mL||Full Range|Median
174549|NCT00089648|Secondary|Trough Plasma Concentrations (Cmin) of Sunitinib||Day 28 of Cycle 1 to Cycle 4|ITT||ng/mL||Full Range|Median
174550|NCT00089648|Secondary|Progression Free Survival (PFS)|PFS was defined as the time from start of study medication to first documentation of objective tumor progression or to death due to any cause that occurred on treatment including within 28 days after the last dose of study medication, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT. 20 subjects were censored.||weeks||Full Range|Median
174551|NCT00089648|Secondary|Overall Survival (OS)|OS was defined as the time from start of study treatment to date of death due to any cause. OS (in weeks) was calculated as [date of death minus first dose date +1]/7. For a subject not expiring, the OS time was censored on the last date of known contact that they were known to be alive. Subjects lacking data beyond the day of the first dose had their OS times censored at 1 day. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT||weeks||95% Confidence Interval|Median
174552|NCT00089648|Secondary|Duration of Response (DR)|DR was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death due to to any cause that occurred within 28 days after the last dose of study medication, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. DR was only calculated for the subgroup of subjects with a confirmed objective response. DR was calculated as [the end date for DR minus first CR or PR that was subsequently confirmed +1]/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT subjects (i.e, all subjects enrolled in the study that received at least 1 dose of study medication) who had a confirmed CR or PR. 14 subjects who had a response were analyzed for DR.||weeks||95% Confidence Interval|Median
174553|NCT00089648|Secondary|Time to Tumor Progression (TTP)|TTP was defined as the time from the date of first dose of study medication to the date of the first documentation of tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|ITT. 20 subjects were censored.||weeks||95% Confidence Interval|Median
174554|NCT00089648|Primary|Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors (RECIST)|Objective disease response = subjects with confirmed complete response (CR) or partial response (PR) according to RECIST. A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|4 week treatment cycles up to 1 year in absence of withdrawal criteria requiring discontinuation including 28 day post study follow up|Intent-to-treat (ITT)=all subjects enrolled in the study that received at least 1 dose of study medication.||participants|||Number
174555|NCT00089635|Secondary|Overall Survival|Kaplan-Meier estimate of time to death from any cause; participants who had not died while on study or were lost to follow-up were censored at their last contact date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).||months||95% Confidence Interval|Median
174556|NCT00089635|Secondary|Duration of Stable Disease|"Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); in those participants who had a best response of stable disease.~Stable Disease is defined as neither sufficient shrinkage of index lesions to qualify for a partial response nor sufficient increase to qualify for progressive disease taking as reference the nadir sum of the products of the longest diameters since the treatment started."|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a best response of stable disease.||weeks||95% Confidence Interval|Median
174557|NCT00089635|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of median time from date of enrollment to date decision was made to end the treatment phase for any reason; participants who complete the treatment phase or who remain in the treatment phase at the completion of the study were censored at this time.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), for whom a decision was made to end treatment for any reason.||weeks||95% Confidence Interval|Median
174558|NCT00089635|Secondary|Time to Disease Progression|Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death date if the death was due to disease progression (whichever comes first); participants who have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).||weeks||95% Confidence Interval|Median
174559|NCT00089635|Secondary|Progression-free Survival Time|Kaplan-Meier estimate of median time from date of enrollment to date of first observed progression or death (whichever comes first); participants who did not progress while on study and did not die while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).||weeks||95% Confidence Interval|Median
174560|NCT00089635|Secondary|Time to Initial Objective Response|Time from date of enrollment to first objective response; participants with stable disease at their last evaluable assessment date were censored at this date and participants with progressive disease while on study were censored after the last response was observed for all participants.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had an objective tumor response at any time on study.||weeks||Full Range|Median
174605|NCT00089583|Primary|Change From Baseline in Serum Lipase at Week 48|Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.||Units per liter (U/L)||Inter-Quartile Range|Median
174633|NCT00089479|Secondary|Overall Survival [Time to Event]|Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive.|Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.|Intent−to−Treat Population||months||95% Confidence Interval|Median
174561|NCT00089635|Secondary|Objective Tumor Response Throughout the Study|Confirmed objective tumor response was defined as a complete response or partial response from enrollment through to the data cut-ff date. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).||participants|||Number
174562|NCT00089635|Primary|Duration of Response|Kaplan-Meier estimate of time time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first) among participants who had a response at any time on study. Participants who responded and did not progress while on study or who died for reasons other than disease progression while on study were censored at their last evaluable assessment date.|From enrollment until the data cut-off date of 22 December 2006. The median follow-up time was 36 weeks.|Subset of Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response at any time on study.||weeks||95% Confidence Interval|Median
174563|NCT00089635|Primary|Objective Tumor Response Through Week 16|Confirmed objective tumor response was defined as a complete response or partial response from enrollment through Week 16. Tumor response was monitored, beginning at Week 8, per a modified version of the World Health Organization (WHO) criteria for tumor response and progression by an independent review committee central assessment. Complete response was defined per modified WHO criteria as disappearance of all lesions (index and non-index). Partial response was defined as ≥ 50% decrease from Baseline in the sum of the products of the longest diameters (SPD) of index lesions. Scans were required to confirm a complete or partial response no earlier than 4 weeks from the time a response of complete or partial response was first documented.|From enrollment through Week 16|Adjudicated Prior Failures Analysis Set, composed of all consented and enrolled participants who were determined to be eligible by the Independent Eligibility Review Committee (IERC).||participants|||Number
174564|NCT00089609|Secondary|Changes in the Molecular Markers of Angiogenesis (Including, But Not Limited to Serum and Urine Vascular Endothelial Growth Factor (VEGF)) Before and After Administration of Docetaxel, Prednisone, Thalidomide and Bevacizumab||Baseline and monthly|The outcome was not assessed. In the study, assessment of circulating apoptotic endothelial cells was the main outcome evaluated for assessing the treatment's antiangiogenic activity. Changes in the molecular markers of angiogenesis will not be pursued.|||||
174565|NCT00089609|Secondary|Usefulness of Dynamic Magnetic Resonance Imaging (MRI) to Monitor the Progression of Bony and Soft Tissue Disease in Metastatic Prostate Cancer|Target lesions in the bone or soft tissues will be identified from the participant computed tomography (CT) scan. Dynamic MRI will be performed after the intravenous administration of 0.1 mmol/kg of Gadolinium chelate. Progression is defined by the RECIST criteria and is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment starts or the appearance of new lesions.|Baseline and at 3 month intervals until progression|The outcome was not assessed as the functionality of dynamic MRI in prostate cancer was poor at the time of this study. Earlier prostate MRI techniques suffered from poor sensitivity and specificity for monitoring progression.|||||
174566|NCT00089609|Secondary|Analyze the Patients Genotype With Regard to Cytochrome P450 2C19 Polymorphism and Correlate That With Pharmacokinetics and Efficacy|Single nucleotide polymorphisms in genes that play an important role in eliminations pathways for docetaxel (in the CYP3A4 and CYP3A5 genes) and thalidomide (CYP2C19) will be evaluated.|Patient entry onto the study|The outcome was not assessed as the clinical significance of cytochrome P450 2C19 polymorphism in angiogenesis is undetermined. This analysis will not be pursued.|||||
174567|NCT00089609|Secondary|Number of Participants With a Significant Increase in Circulating Apoptotic Endothelial Cell (CAEC) Level|"The assay utilized has no standard curve. Categorizing patients with ≥ 75% PSA decline in one group and < PSA decline in another group, every patient is their own control with comparison of CAEC at baseline vs. 6 weeks (after two cycles of treatment). Blood is drawn from the patient and a million viable mononuclear cells are counted and then it is determined how many CAECs are in the specimen. The cell count is then compared from baseline to post 2 cycles of treatment. Thus, significant increase is dependent upon this comparison and varies between patients."|Baseline and at 6 weeks (after two cycles of treatment)|Only 17/60 participants were evaluable for this outcome. Per protocol CAECs were not assessed in the expansion cohort.||participants|||Number
174568|NCT00089609|Secondary|Plasma Concentrations of Docetaxel and Thalidomide and Clinical Activity or Toxicity|The analysis will be performed using a validated method based on liquid chromatography with mass-spectrometric detection.|Pre-dose on C1D1, 5 minutes before the end of infusion, and 15, and 30 minutes, and 1, 2,4,8, and 24 hours after the end of infusion|The outcome was not assessed as the analysis of plasma bevacizumab concentrations was the main pharmacokinetic secondary outcome in the study. The plasma levels of docetaxel and thalidomide (without bevacizumab) had minimal significance in this study. Analysis of plasma concentrations of docetaxel and thalidomide will not be done.|||||
174569|NCT00089609|Secondary|Number of Participants Who Died After a Follow Up of 34 Months Following Treatment|From on study date to date of death at 34 months.|34 months|Per protocol, this outcome was not assessed for the expansion cohort.||participants|||Number
174620|NCT00089505|Primary|Time From Randomization to Virologic Failure or Death for Participants Without SD NVP Exposure Prior to Study Entry|5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Throughout study with median follow-up 72 weeks and range from 0 to 180 weeks.|The analysis was intent to treat per protocol.||weeks||95% Confidence Interval|Number
174570|NCT00089609|Secondary|Disease Progression by Clinical and Radiographic Criteria Without the Use of Prostate-Specific Antigen (PSA)|Clinical and radiographic response was measured by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking s reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded or the appearance of one or more new lesions.|up to 34 months|"Only 33/60 participants had measurable disease and were evaluable for this outcome measure.~Per protocol, disease progression by clinical and radiographic criteria without the use of PSA was not assessed for the expansion cohort."||participants|||Number
174571|NCT00089609|Secondary|Time to Progression Using Bubley Criteria|Time to disease progression was based on the Prostate-Specific Antigen (PSA) Working Group 1 Criteria (Bubley Criteria) and standard Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease. Per the criteria, investigators report at a minimum a PSA decline of at least 50% and this must be confirmed by a second PSA value 4 or more weeks later. Patients may not demonstrate clinical or radiographic evidence of disease progression during this time period.|up to 40 months|Per protocol, time to progression using Bubley Criteria was not assessed for the expansion cohort.||Months||95% Confidence Interval|Median
174572|NCT00089609|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|37 months|||Participants|||Number
174573|NCT00089609|Primary|Immune Response|Cellular immune response and cytokines were evaluated after two cycles of therapy in the expansion cohort. Those cycles included treatment with bevacizumab and docetaxel as a pre-medication.|6 weeks|Cellular immune response and cytokines were not analyzed as the study outcomes were concentrated on the dual-anti-angiogenesis inhibition properties of the regimen and not immunomodulatory changes.|||||
174574|NCT00089609|Primary|Number of Participants Who Had a Prostate-specific Antigen (PSA) Response|PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression.|21.6 months|The main cohort was designed to evaluate clinical progression and the expansion cohort was designed to evaluate immune response. Thus the expansion cohort is not included here.||Participants|||Number
174575|NCT00089583|Secondary|Correlation Between Plasma APV Exposure and Plasma vRNA, CD4+ Cell Counts, and the Occurrence of Adverse Events|No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.|Week 48|PK Population|||||
174576|NCT00089583|Secondary|Number of Participants Reporting Perfect Adherence Over the 3 Days Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by Study Coordinator Using the Pediatric AIDS Clinical Trials Group (PACTG) Adherence Questionnaire|The PACTG Adherence Questionnaire records individual study drugs, the expected number of doses/24 hour period, and the number of doses missed in the 3 days prior to the study visit. Responses were summarized by age cohort, study drug, treatment regimen, and visit for exploratory analysis only.|Weeks 2, 12, 24, and 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
174577|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Week 60 through Week 240|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable||Participants|||Number
174578|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Baseline through 48 Weeks|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable||participants|||Number
174579|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) Since the Week 48 Analysis With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. remaining in the study after Week 48 and failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|After Week 48 through Week 240|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.||Participants|||Number
174580|NCT00089583|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.||participants|||Number
174581|NCT00089583|Secondary|Change From Baseline in the Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Week 2, 12, 24, 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.||Percentage of TLs that are CD4+ cells||Inter-Quartile Range|Median
174582|NCT00089583|Secondary|Percentage of Total Lymphocytes (TLs) That Are CD4+ Cells at Baseline and Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.||Percentage of TLs that are CD4+ cells||Inter-Quartile Range|Median
174583|NCT00089583|Secondary|Change From Baseline in CD4+ Cell Count at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline was calculated as the value at Weeks 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.||cells/cu mm||Inter-Quartile Range|Median
174584|NCT00089583|Secondary|Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 2, 12, 24, and 48|Blood samples of participants were collected for the measurement of CD4+ cell count. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. The number of participants analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) participants.||Cells per cubic millimeter (cells/cu mm)||Inter-Quartile Range|Median
174585|NCT00089583|Secondary|Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.||participants|||Number
174586|NCT00089583|Secondary|Median Change From Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA. Change from Baseline at Weeks 2, 12, 24, and 48 was calculated as value at Week 2, 12, 24, and 48 minus the value at Baseline.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.||log10/copies||Inter-Quartile Range|Median
174587|NCT00089583|Secondary|Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 2, 12, 24, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA.|Baseline and Weeks 2, 12, 24, and 48|ITT-E Population. In the observed analysis, data are presented for the number of par. still enrolled in the study at a certain time point. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1 week prior PI therapy with no more than 3 PIs before trial enrollment) par.||log10 copies/mL||Inter-Quartile Range|Median
174588|NCT00089583|Secondary|Number of Participants (Par.) With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 2,12, 24, and 48 (MSD=F)|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation = Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 2, 12, 24, and 48|Intent-to-Treat Exposed (ITT-E) Population. Only those par. contributing data at the indicated time points were analyzed. The number of par. analyzed represents the sum of the PI-naïve (received <1 week's treatment with a PI) and -experienced (received >1week prior PI therapy with no more than 3 PIs before trial enrollment) par.||participants|||Number
174589|NCT00089583|Secondary|Number of Participants (Par.) With Virological Outcome (Plasma HIV-1 Ribonucleic Acid [RNA] <400 Copies/mL) at Week 48|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced.Virologic success was defined as plasma HIV-1 RNA <400 copies/mL. Virologic failure: (1) HIV-1 RNA >=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 >=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons, (c) missing data during window but still on study.|Week 48|Intent-to-Treat Exposed (ITT-E) Population: par. with documented evidence of receiving >=1 treatment dose. Only par. contributing data were analyzed. The number of par. analyzed is the sum of the PI-naïve (received <1week's treatment with a PI) and -experienced (received >1week prior PI therapy with no more than 3 PIs before trial enrollment) par.||participants|||Number
174590|NCT00089583|Secondary|Plasma FPV t1/2|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
174591|NCT00089583|Secondary|Plasma FPV Tmax|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
174592|NCT00089583|Secondary|Plasma FPV CL/F Following Dosing Expressed in mg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
174593|NCT00089583|Secondary|Plasma FPV CL/F Following Dosing Expressed in mg/kg|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
174594|NCT00089583|Secondary|Plasma FPV Cmax and Cτ|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
174595|NCT00089583|Secondary|Plasma FPV AUC (0-τ)|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
174596|NCT00089583|Secondary|Plasma RTV t1/2|alf-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||hours||95% Confidence Interval|Geometric Mean
174597|NCT00089583|Secondary|Plasma RTV Tmax|The time to reach the maximum concentration (Cmax) at steady state is defined as (tmax).|Week 48|PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||hours||Full Range|Median
174598|NCT00089583|Secondary|Plasma RTV CL/F Following Dosing Expressed in mg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ).|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||mL/min||95% Confidence Interval|Geometric Mean
174599|NCT00089583|Secondary|Plasma RTV CL/F Following Dosing Expressed in mg/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: RTV Dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||mL/min/kg||95% Confidence Interval|Geometric Mean
174600|NCT00089583|Secondary|Plasma RTV Cτ|The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||µg/mL||95% Confidence Interval|Geometric Mean
174601|NCT00089583|Secondary|Plasma RTV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data at the indicated time points were analyzed.||µg/mL||95% Confidence Interval|Geometric Mean
174602|NCT00089583|Secondary|Plasma Ritonavir (RTV) AUC (0-τ)|Plasma samples were assayed for RTV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.|Week 48|PK Population: all participants for whom a plasma PK sample was analyzed. Participants in the FPV arm did not take RTV; hence, they were not analyzed for this outcome measure. In the FPV/RTV arm, only those participants contributing data were analyzed.||hr*µg/mL||95% Confidence Interval|Geometric Mean
174603|NCT00089583|Primary|Number of Participants With Treatment-emergent (TE) Grade 3/4 Clinical Chemistry Laboratory Abnormalities|"A toxicity was considered TE if it was > than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Leucopenia is the decrease in the number of leucocytes (white blood cells [WBCs]); neutropenia is the decrease in the number of neutrophils (type of WBCs). Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs: Grade 3 is severe; Grade 4 is potentially life-threatening. ULN, upper limit of normal; LDL, low-density lipoprotein; PC, platelet count."|Baseline (Day 1) until Week 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
174604|NCT00089583|Primary|Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) at Week 48|Blood samples of the participants were collected for the evaluation of AST and ALT. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in AST and ALT was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.||International units per liter (IU/L)||Inter-Quartile Range|Median
174606|NCT00089583|Primary|Change From Baseline in Triglycerides, Total Cholesterol, Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, and Serum Glucose at Week 48|Blood samples of all participants were collected under fasting conditions for the evaluation of triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, and serum glucose was calculated as the value at Week 48 minus the value at Baseline.|Baseline (Day 1) and Week 48|Safety Population. Only those participants contributing data were analyzed.||Millimoles per liter (mmol/L)||Inter-Quartile Range|Median
174607|NCT00089583|Primary|Number of Participants Who Permanently Discontinued the Treatment Due to Any Adverse Event (AE)|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Week 48|Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment.||participants|||Number
174608|NCT00089583|Primary|Plasma APV t1/2|The apparent terminal phase half-life (t1/2) is calculated as loge2/λz. The apparent terminal phase rate constant (λz) is the slope of the terminal portion of the logarithmically transformed concentration-time data as estimated by linear regression.|Week 48|PK Population. Only those participants contributing data were analyzed.||hours||95% Confidence Interval|Geometric Mean
174609|NCT00089583|Primary|Plasma APV Tmax|The time to reach the maximum concentration (Cmax) at steady state is defined as tmax.|Week 48|PK Population. Only those participants contributing data were analyzed.||hours||Full Range|Median
174610|NCT00089583|Primary|Plasma APV CL/F Following Dosing Expressed in mg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).|Week 48|PK Population. Only those participants contributing data were analyzed.||Milliliters per minute (mL/min)||95% Confidence Interval|Geometric Mean
174611|NCT00089583|Primary|Plasma APV CL/F Following Dosing Expressed in mg/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.||Milliliters/minute/kilogram (mL/min/kg)||95% Confidence Interval|Geometric Mean
174612|NCT00089583|Primary|Plasma APV Cτ|The plasma concentration at the end of the dosing interval at steady-state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
174613|NCT00089583|Primary|Plasma APV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
174614|NCT00089583|Primary|Plasma Amprenavir (APV) AUC (0-tau[τ])|Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hr, hour; µg, micrograms; mL, milliliter.|Week 48|Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.||hr*µg/mL||95% Confidence Interval|Geometric Mean
174615|NCT00089544|Secondary|Response to Pre-operative Therapy Assessed Using RECIST Criteria||From start of treatment to time of surgery.|"This analysis was not carried out due to the small number of patients accrued to the study. See section Limitations and Caveats."|||||
174616|NCT00089544|Secondary|Wound Complication (Grades 2, 3, 4, and 5) as Measured by CTCAE v3.0|Will be estimated using a binomial distribution and accompanied by the associated 95% confidence interval.|From start of treatment to time of surgery|"This analysis was not carried out due to the small number of patients accrued to the study. See section Limitations and Caveats."|||||
174617|NCT00089544|Primary|Treatment Delivery With Compliance Defined as Receiving at Least 95% of the Pre-operative Protocol Dose of RT, All 3 Cycles of MAID (if Applicable), and Receive Thalidomide on 75% of the Days During Radiation|Was to be estimated using a binomial distribution and accompanied by the associated 95% confidence interval. Due to early study closure, this endpoint could not be fully evaluated per the protocol plan.|Duration of treatment (which can continue up to approximately 15 months).|Eligible patients who started study treatment.||participants|||Number
174618|NCT00089505|Secondary|Percent of Participants Who Reported to Never Missed Any of the Study Drug Regimen in the Past Month|Self-reported adherence at week 48 and 96 while participants remained on randomized regimen. Adherence interviews for each antiretroviral drug drug the participant is taking was performed by site personnel every 24 weeks. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.|Numbers presented use as-treated approach.||percent of participants|||Number
174619|NCT00089505|Secondary|Number of Participants Who Received NVP-containing Regimens at Randomization and Experienced NVP-associated Rash or Grade 2+ Liver Lab Abnormality|Any grade of rash or grade 2+ liver lab abnormality events that were claimed to be NVP associated (definitely, probably, or possibly) by site investigators were evaluated. Grade 2+ liver lab abnormality is defined as aspartate aminotransferase (AST)>=2.6 x ULN or alanine aminotransferase (ALT)>=2.6 x ULN.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP arm. Throughout study for NoNVP/NVP arm.|Numbers presented use the as-treated approach.||participants|||Number
174632|NCT00089479|Secondary|Breast Cancer Free Survival [Number of Events]|Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.|Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .|Intent−to−Treat Population||participants|||Number
174621|NCT00089505|Primary|Time From Randomization to Virologic Failure or Death for Participants Who Had SD NVP Exposure Prior to Study Entry|5th and 10th Percentiles in weeks from randomization to virologic failure (VF) or death. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) with median follow-up 72 weeks and range from 0 to 144 weeks.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).||weeks||95% Confidence Interval|Number
174622|NCT00089505|Secondary|Number of Participants Who Experienced HIV-related Disease Progression or Death|Worsening to WHO stage III/IV (among subjects who had WHO stage I/II at baseline) and death were the composite secondary endpoint. WHO Disease Staging System for HIV Infection and Disease in Adults and Adolescents is an approach for use in resource limited settings in studies of progression to symptomatic HIV disease. There are 4 stages of disease staging, 1 being the least severe and 4 being the most severe disease stage based on the HIV related symptoms and diagnoses. Please refer to the following web page for detailed staging criteria: http://www.who.int/docstore/hiv/scaling/anex1.html|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).||participants|||Number
174623|NCT00089505|Secondary|Number of Participants Who Experienced Treatment-related Toxicity That Led to Discontinuation of Randomized Regimen.|The outcome is defined as treatment-related toxicity (as evaluated by sites), regardless of grade, that led to discontinuation of randomized regimen. For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use as-treated method.||participants|||Number
174624|NCT00089505|Secondary|CD4 Count Change From Randomization|Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (last CD4 before/on treatment start date). For NVP/NVP and NVP/LPV_r arms, data through DSMB review cutoff (October 6, 2008) were used to report the outcome. For NoNVP/NVP and NoNVP/LPV_r arms, since the follow-up continued as planned, data through overall study were used.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r. Week 48 and 96.|Changes were calculated using the intent-to-treat approach (i.e. ignoring changes from randomized treatment) but no imputation was done for missing values.||cells/mm^3||Inter-Quartile Range|Median
174625|NCT00089505|Secondary|Percent of Participants Who Experienced Virologic Failure or Died|Results report cumulative percent of participants reaching virologic failure (VF) or death by week 48 and week 96 calculated using the Kaplan-Meier method. VF is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r arms. Throughout study for NoNVP/NVP and NoNVP/LPV_r arms.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).||Percent of participants||95% Confidence Interval|Number
174626|NCT00089505|Secondary|Number of Participants Who Experienced Virologic Failure or Died.|Virologic failure (VF) is defined as a plasma HIV-1 RNA level that is 1 log10 below baseline 12 weeks after treatment is initiated or as a plasma HIV-1 RNA level that is >=400 copies/mL at or after 24 weeks of treatment, regardless of whether randomized treatment was being taken at the time of VF.|Through database cutoff for DSMB review (by October 6, 2008) for NVP/NVP and NVP/LPV_r. Throughout study for NoNVP/NVP and NoNVP/LPV_r.|Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).||participants|||Number
174627|NCT00089479|Secondary|Disease Free Survival Including Any New Cancer as Event [Time to Event]|Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||months||95% Confidence Interval|Median
174628|NCT00089479|Secondary|Disease Free Survival Including Any New Cancer as Event [Number of Events]|Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||participants|||Number
174629|NCT00089479|Secondary|Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event|Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||months||95% Confidence Interval|Median
174630|NCT00089479|Secondary|Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]|Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||participants|||Number
174631|NCT00089479|Secondary|Breast Cancer Free Survival [Time to Event]|Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||months||95% Confidence Interval|Median
174650|NCT00089141|Secondary|Bronchiolitis Obliterans|Development of bronchiolitis obliterans during treatment|within 4 years|||participants|||Number
174634|NCT00089479|Primary|Disease Free Survival [Time to Event]|Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||months||95% Confidence Interval|Median
174635|NCT00089479|Secondary|Overall Survival [Number of Events]|Number of patients who died/were alive.|Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.|Intent−to−Treat Population||participants|||Number
174636|NCT00089479|Primary|Disease Free Survival [Number of Events]|Number of patients with/without recurrence of breast cancer, or death due to any cause.|Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.|Intent−to−Treat Population||participants|||Number
174637|NCT00089414|Secondary|Change in Beck Depression Inventory (BDI) Factors Associated With Premenstrual Symptoms|"The Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Total scores are interpreted per these ranges:~0–9: indicates minimal depression 10–18: indicates mild depression 19–29: indicates moderate depression 30–63: indicates severe depression."|Every 2 weeks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior. Data collected insufficient for analysis.|||||
174638|NCT00089414|Primary|Change in Premenstrual Tension Syndrome Scale (PMTS) Factors Associated With Premenstrual Symptoms.|The PMTS observer scales assess symptoms in ten different domains including irritability-hostility; tension; efficiency; dysphoria; moodiness; motor coordination; mental-cognitive functioning; eating habits; sexual drive and activity; physical symptoms and social impairment. They have been used to measure premenstrual symptom severity and response to treatment in several clinical trials and prevalence studies. Score ranges from no symptoms to severe symptoms on a scale of 0 to 6, with 0 being no symptoms and 6 being severely symptomatic.|Every 2 weeks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior. Data collected insufficient for analysis.|||||
174639|NCT00089414|Secondary|Change in Clinical Global Impression Scale (CGI) Factors Associated With Premenstrual Symptoms.|The CGI was developed for use in NIMH-sponsored clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication.1 The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function. The CGI actually comprises two companion one-item measures evaluating the following: (a) severity of psychopathology from 1 to 7 and (b) change from the initiation of treatment on a similar seven-point scale, with 1 being normal/more improved and 7 being severe/worse.|Every 2 wks for 3 months|This study was terminated early due to confounding factors in design. Protocol terminated after receiving information from manufacturer (Pharma) that CDB-2914 crosses the blood-brain barrier, invalidating Arm #3 due to potential Central Nervous System effect of the compound on behavior. Data collected insufficient for analysis.|||||
174640|NCT00089297|Secondary|Overall Survival|Overall survival is defined as the time from registration to death of any causes.|Weekly during treatment, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in the analysis.||Months||95% Confidence Interval|Median
174641|NCT00089297|Secondary|Progression-free Survival|Progression-free survival was defined as the time from registration to documented progression or death without progression. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in the analysis.||Months||95% Confidence Interval|Median
174642|NCT00089297|Secondary|Proportion of Patients With Objective Response by RECIST|Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR.|Assessed at weeks 7, 14, 18, 20, and then every every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry|Only eligible patients are included in this analysis.||proportion of patients||95% Confidence Interval|Number
174643|NCT00089297|Primary|Event-free Survival Rate at 1 Year|Event-free survival rate at 1 year was defined as the proportion of patients who did not have disease progression, primary site surgery, or death after being followed for 1 year.|Assessed at 1 year.|Only eligible patients are included in the analysis.||proportion of patients||95% Confidence Interval|Number
174644|NCT00089141|Secondary|End of Systemic Treatment|Withdrawal of all immunosuppressive treatment without recurrent malignancy|within 4 years|||participants|||Number
174645|NCT00089141|Secondary|Withdrawal of Prednisone|Withdrawal of treatment with prednisone after improvement or resolution of chronic GVHD|within 4 years|||participants|||Number
174646|NCT00089141|Secondary|Death|Death from any cause after enrollment in the study|within 4 years|||participants|||Number
174647|NCT00089141|Secondary|Death or Recurrent Malignancy|Death due to any cause or development of recurrent malignancy at any time after enrollment|within 4 years|||participants|||Number
174648|NCT00089141|Secondary|Non-relapse Mortality|Death without prior development of recurrent malignancy|within 4 years|||participants|||Number
174649|NCT00089141|Secondary|Recurrent Malignancy|Development of recurrent malignancy after enrollment in the study|within 4 years|||participants|||Number
174654|NCT00089076|Secondary|Mean Change in % of CD3+CD4- for the Marker CD45RO+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.||percentage of change of CD3+CD4-||Standard Error|Mean
174655|NCT00089076|Secondary|Mean Change in % of CD3+CD4+ for Marker CD45RO+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.||percentage of change of CD3+CD4+||Standard Error|Mean
174656|NCT00089076|Secondary|Mean Change in % of CD3+CD4- for Marker HLA-DR+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.||percentage of change of CD3+CD4-||Standard Error|Mean
174657|NCT00089076|Secondary|Mean Change in % of CD3+CD4+ for Marker HLA-DR+|Flow cytometric analysis of T-cell surface markers before and 1 month after initiation therapy|Before treatment to 1 month after therapy initiation|The analysis population contains patients that had peripheral blood available for analysis from before and 1 month after initiating therapy along with being able to conduct the analysis on the marker. This resulted in the number of participants analyzed being less than the enrolled participants.||percentage of change of CD3+CD4+||Standard Error|Mean
174658|NCT00089076|Secondary|Duration of Response (Phase 2)|Duration of response will be calculated from the documentation of confirmed response until the date of progression in the subset of patients who respond.|From response to progression (up to 2 years)|No participants proceeded to Phase 2 for evaluation.|||||
174659|NCT00089076|Secondary|Overall Survival (Phase 2)|The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.|From registration to death (up to 2 years)|No participants proceeded to Phase 2 for evaluation.|||||
174660|NCT00089076|Secondary|Time to Progression (Phase 2)|The time to progression is defined as the time from registration to the time of progression. Those who die will be considered to have had disease progression unless documented evidence clearly indicates no progression has occurred. The distribution of time to progression will be estimated using the method of Kaplan-Meier.|From registration to progression (up to 2 years)|No participants proceeded to Phase 2 for evaluation.|||||
174661|NCT00089076|Primary|Number of Overall Confirmed Responses(Complete Response or Partial Response)|Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.|From registration to month 7|||participants|||Number
174662|NCT00088972|Secondary|Ki-67 Expression|The difference between the two arms in the percent of patients with non-zero ki-67 expression over the two time periods (baseline and 1-year).|1 year||||||
174663|NCT00088972|Primary|Mammographic Density|The primary outcome measure is change in mammographic density. The null hypothesis is that there is no difference between the arms in change in mammographic density over one year versus the alternative that the treatment arm reduces mammographic density by 10 points (percent of pixels highlighted) or more over one year compared to the change in the placebo arm.|1 year|Counts represent number of patients for by arm for whom a 1 year mammographic density image was submitted. However, since the study was closed early due to poor accrual, there was insufficient accrual to evaluate study endpoints, and these images were never analyzed.|||||
174664|NCT00088907|Secondary|Overall Response Rate|"Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Complete response (CR) was defined disappearance of all tumor lesions. Partial response (PR) was defined as as at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. Overall response rate= CR+PR.~Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles).~All eligible and treated patients were included in the analysis."|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients||percentage of participants||95% Confidence Interval|Number
174665|NCT00088907|Secondary|Time to Progression|"Time to progression is defined as time from registration to disease progression. Disease progression was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, and/or the appearance of one or more new lesion(s), and/or unequivocal progression of existing nontarget lesions .~Tumor measurements may be made using physical examination, CT scans or MRI scans. While on protocol treatment, tumor measurement by physical examination to be done every 4 weeks, and tumor measurement by CT/MRI scans to be done every 8 weeks (every 2 treatment cycles).~All eligible and treated patients were included in the analysis."|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients||months||95% Confidence Interval|Median
174666|NCT00088907|Primary|Overall Survival|Overall survival is defined as time from registration to death from any cause. All eligible and treated patients were included in the analysis.|assessed every 3 months if patient is < 2 years from study entry then every 6 months if patient is 2-5 years from study entry. No specific requirements if patient is more than 5 years from study entry.|eligible and treated patients||months||95% Confidence Interval|Median
174667|NCT00088881|Secondary|3-year Overall Survival (OS) Rate|Overall survival (OS) is defined as the time from step 1 registration to death of any cause. OS is censored at the date last known alive for cases that are alive. The 3-year OS rate is defined as the probability of patients remaining alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years; then annually to 10 years from patient entry.|Eligible and treated patients||probability||95% Confidence Interval|Number
174668|NCT00088881|Secondary|3-year Time to Treatment Failure (TTF) Rate|Time to treatment failure (TTF) is defined as the time from step 1 registration to disease progression or death. TTF is censored at last documented progression free for cases without progression. The 3-year TTF rate is defined as the probability of patients remaining free from treatment failure at 3 years.|Assessed every 3 months for one year; every 4 months for the second year; then every 6 months for 3 years; then annually to 10 years from patient entry.|Eligible and treated patients||probability||95% Confidence Interval|Number
174669|NCT00088881|Primary|Functional CR in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.|Patients will be considered a functional CR if they meet the criteria for a CR, or if they meet the criteria for a CRu or partial response (PR) by CT and are PET negative. Please see primary outcome #1 for the definition of CR and CRu. PR is defined as: A decrease of >50% in the SPD (sum of products of the diameters) of the six largest (or less) dominant nodes or extra-nodal masses. No increase in the size of the liver or the spleen. No unequivocal progression in any non-measurable or non-dominant site. Splenic and hepatic nodules must regress by >50% in SPD (sum of the products of the diameters). Bone marrow assessment is not relevant for determination of a PR because it is assessable and not measurable disease. No new sites of disease.|Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin|Eligible and treated patients.||proportion of participants||95% Confidence Interval|Number
174670|NCT00088881|Primary|Complete Response (CR) +Complete Response/Uncertain (CRu) in Patients Treated With R-CHOP Followed by 90-Yttrium -Zevalin™.|Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin’s Lymphoma (Cheson, 1999). CR is defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization (normal limits of institutional labs) of those biochemical abnormalities (e.g., LDH) definitely attributed to NHL. CRu is defined as meeting the criteria of CR except one or more of the followings: A residual dominant node (or extra-nodal mass) that is currently > 1.5 cm in greatest diameter that has decreased by > 75% from baseline in the product of its diameters. Individual dominant nodes (or extra-nodal masses) that were previously confluent must have decreased by > 75% in SPD compared with the size of the original mass. Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia).|Assessed after 2 cycles of R-CHOP, after completion of R-CHOP, and at Week 12 After 90-Yttrium Zevalin|Eligible and treated patients||proportion of participants||95% Confidence Interval|Number
174671|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores|The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.||units on scale||95% Confidence Interval|Least Squares Mean
174672|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores|The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.||units on a scale||95% Confidence Interval|Least Squares Mean
174673|NCT00088634|Secondary|Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores|The PANSS is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS||units on a scale||95% Confidence Interval|Least Squares Mean
174674|NCT00088634|Primary|Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale) Total Score|The BPRS consists of 18 ordered categorical items (from “not present” to “extremely severe,” on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately.|Baseline and 6 weeks|Efficacy analyses will be based on the ITT (intent-to-treat)population. The ITT population will consist of all patients who are randomized, taken one dose of study medication and had at least 1 post-baseline efficacy assessment of the PANSS.||units on a scale||95% Confidence Interval|Least Squares Mean
174675|NCT00088621|Primary|Number of Subjects With an Adverse Events in a One Year Open Label Lurasidone Study||1 year|Number of subjects that entered into the extension trial.||participants|||Number
174676|NCT00088595|Secondary|The Overall Safety and Tolerability of Pasireotide|Safety assessments consisted of recording all AEs and serious adverse events (SAEs), the regular monitoring of hematology, blood chemistry, vital signs, physical condition and body weight.|At least 15 days|The safety population consisted of all patients who received study drug (i.e. who started the pasireotide injections) and was thus identical to the Intent to treat (ITT) population.||Participants|||Number
174840|NCT00086580|Secondary|Kaplan Meier Estimates for Time to Disease Progression Assessed by the Independent Response Review Panel (IRRP)|Time to disease progression was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease as determined by IRRP. Results are stated in months.|Up to 6 years|Full analysis set||months||95% Confidence Interval|Median
174677|NCT00088595|Secondary|The Number of Patients (Participants) With Overall Tumor Response|The disappearance of all lesions was considered a complete response and at least a 30% decrease in the diameter of lesions was considered a partial response (PR). Progressive disease (PD) required a 20% increase in the sum of the diameters of lesions and changes that did not qualify for PR or PD were considered stable disease. Progression not documented was defined as unknown. No more than a 10% increase in biochemical values, and no clinical signs of DP with complete or adequate control over symptoms were defined as complete treatment success and partial treatment success, respectively.|At least 15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.||Participants|||Number
174678|NCT00088595|Secondary|Duration of Partial Symptom Control (Days) by Dose Class|Partial symptom control: an average of less than four bowel movements per day for at least 15 consecutive days, with no more than six episodes per any given day, and an average of less than two daily flushing episodes over the same given time interval.|up to 15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= then number of patients with partial sympton control||Days||Standard Deviation|Mean
174679|NCT00088595|Secondary|Duration of Complete Symptom Control (Days) by Dose Class|Complete symptom control: an average of three or less bowel movements per day for at least 15 consecutive days, with no more than three episodes on any given day, and no episodes of flushing over the time interval being studied.|15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments. n= the number of patients with complete symptom control.||Days||Standard Deviation|Mean
174680|NCT00088595|Primary|Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary|"Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied.~Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval.~Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level."|15 days|The efficacy analysis population (EAP) consisted of 44 patients all of whom had at least one efficacy assessment available after receiving at least one dose of study drug, but excluded 1 patient who had no post-baseline efficacy assessments.||participants|||Number
174681|NCT00088465|Primary|Number of Participants With Extrapyramidal Symptoms at Any Time|Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) >3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.|Randomization to end of study up to 76 months|Participants with a baseline and at least one post-baseline measurement.||participants|||Number
174682|NCT00088465|Primary|Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint|PCS weight gain is defined as a ≥7% increase in weight from baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.||participants|||Number
174683|NCT00088465|Primary|Change From Baseline in Weight at Month 76 Endpoint|Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||kilogram (kg)||Standard Deviation|Mean
174684|NCT00088465|Primary|Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline|Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides <150 mg/dL at baseline to ≥200 mg/dL and <500 mg/dL any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.||participants|||Number
174685|NCT00088465|Primary|Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline|Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.||participants|||Number
174686|NCT00088465|Primary|Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline|High ALT is defined as a baseline value of <3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of <5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of <2 times the ULN to ≥2 times the ULN at any time post baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.||participants|||Number
174687|NCT00088465|Primary|Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline|Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.|Randomization to end of study up to 76 months|Participants with normal baseline and at least one post-baseline measurement.||participants|||Number
174688|NCT00088465|Secondary|Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year|Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) ([ng/mL]/[mg/day]).|Randomization to end of study up to 76 months|Participants who took at least one dose of study drug and had post-baseline measurements.||(ng/mL)/(mg/day)||Standard Deviation|Mean
175359|NCT00077857|Secondary|Overall Survival|Overall Survival was measured as the time from the date of randomization to the date of death.|Throughout the study. Median observation time was approximately 16 months.|Intent to treat population included all randomized participants.||Months||95% Confidence Interval|Median
174689|NCT00088465|Secondary|Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint|Self-rated scale that measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1='very dissatisfied' to 5='very satisfied'), preference comparing current study medication versus previous medications (scored from 1='much prefer previous medication' to 5='much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1='much less side effects' to 5='much more side effects'). Range of possible scores is 3-15.|Randomization to end of study up to 76 months|All randomized participants.||percent of participants|||Number
174690|NCT00088465|Secondary|Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint|The Subjective Well-Being under Neuroleptic Treatment-Short Form (SWN-S) is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). Possible total score ranges from 20-120.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
174691|NCT00088465|Secondary|Days of Hospitalization|This is the total number of days for all hospitalized patients that were admitted to General, Psychiatric Ward as well as Intensive Care Unit (ICU).|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.||days|||Number
174692|NCT00088465|Secondary|Number of Psychiatric Visits|Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.||visits|||Number
174693|NCT00088465|Secondary|Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint|A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
174694|NCT00088465|Secondary|Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint|Heinrich-Carpenter QLS is an interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning), for a total score range of 0-126. Results are presented as change in Total score.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
174695|NCT00088465|Secondary|Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint|Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline, up to 72 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Error|Mean
174696|NCT00088465|Secondary|Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint|PANSS General Psychopathology Subscale is the Remaining 16 PANSS questions or PANSS Question15 through Question 30. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 16 items is defined as the PANSS General Psychopathology Subscales. Possible score ranges from 16 to 112.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
174697|NCT00088465|Secondary|Change From Baseline in PANSS Negative Scores at Month 76 Endpoint|PANSS questions 8-14. Assesses negative symptoms associated with schizophrenia. 7 items make up the negative scale (e.g. blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
174698|NCT00088465|Secondary|Change From Baseline in PANSS Positive Scores at Month 76 Endpoint|PANSS questions 1-7. Assesses positive symptoms associated with schizophrenia. 7 items make up the positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
174699|NCT00088465|Secondary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint|Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.|Baseline, up to 76 months|Participants with a baseline measurement and at least one post-baseline measurement, last observation carried forward (LOCF).||units on a scale||Standard Deviation|Mean
174700|NCT00088465|Primary|Number of Participants With Adverse Events (AE)|The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.|Randomization to end of study up to 76 months|All randomized participants who took at least one dose of study drug.||participants|||Number
174725|NCT00087698|Primary|Pathological Complete Response|"Number of participants with results of pathological review that indicated a complete response. Pathological complete response should be evaluated at the time of surgery (Extrapleural Pneumonectomy [EPP]).~Resected tissue or pleural fluid should be sent for pathological and histological evaluation."|Surgery (at least 3 weeks post last dose of chemotherapy, up to a maximum interval of 8 weeks)|All participants who had undergone surgery.||participants|||Number
174701|NCT00088374|Secondary|Number of Participants With Flow Dynamics Measured by DCE MRI Within the Renal and Non-renal Tumor|Dynamic images will be acquired before and after the intravenous administration of 0.1 mmol/kg of Gadolinium Diethylene triamine pentaacetic acid (DTPA). Time activity curves will be generated over a period of ten minutes. The parameter to be measured is the forward contrast transfer rate (Ktrans), the reverse contrast transfer rate (Kep), and/or the extravascular extracellular space volume fraction (Ve). Flow dynamics are a measure of blood flow changes in the tumor and are determined using the parameters we had previously defined (Ktrans, Kep, etc.).|Baseline and during therapy (12 weeks)|It is not the magnitude of changes in Ktrans, Kep, and Ve that limit our abililty, but the fact that this data was available in only a small number of patients.||participants with changes|||Number
174702|NCT00088374|Secondary|Number of Patients in Whom Renal Tumors Could be Identified by Positron Emission Tomography (PET)Based on Fludeoxyglucose 18F (18FDG) Uptake|Images were acquired after the intravenous administration of 18FDG and H2015 and used to analyze glucose uptake and estimate blood flow. The parameter to be measured is SUV (standard uptake value(s)) and/or mL/min/gm.|Baseline and at 12 weeks|Response was not the endpoint. The SUV values were in the 2-3 range and hence renal tumors could not be clearly identified by this technique in any of the patients.||participants|||Number
174703|NCT00088374|Secondary|The Number of Participants With HIF, HSP90, and HSP70 Modulation in Resected Tumor Tissue and/or Peripheral Blood Lymphocytes|Measurement of HIF, HSP90 and HSP70 levels by Western Blot in tumor tissue and/or lymphocytes to assess modulation of these biomarkers in response to 17 AAG treatment. Pretreatment tumor samples (when available) and resected tumors (in those patients who did not have a response and underwent surgical resection of their tumor) were to be used for this analysis. Levels of Hsp90, Hsp70, HIF and HIF transcriptional targets in resected tumor will be compared to respective levels in tumors previously resected from other VHL patients (not treated with 17AAG).|Baseline and 12 weeks|This analysis was not performed as it was felt that there were not a sufficient number of samples to enable a meaningful analysis.|||||
174704|NCT00088374|Secondary|The Number of Participants With Adverse Events|"Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.~The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for adverse event reporting. For a detailed description see the link in the Protocol Link module."|1 yr, 364 days|||participants|||Number
174705|NCT00088374|Secondary|Number of Participants With a Non-renal Tumor Response|Number of patients who have a PR or CR of non-renal lesions (pancreatic tumors, pheochromocytomas, and hemangioblastomas). The effect of treatment on the lesions will be evaluated at baseline and at the time of restaging (12 weeks) per RECIST criteria. RECIST is defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesions. Lesions are either measurable or non-measurable using the criteria. See the protocol Link module for the full criteria if desired.|Baseline and 12 weeks|There were only two patients with measurable nonrenal tumors and hence the number of participants analyzed is correct.||participants|||Number
174706|NCT00088374|Primary|Number of Participants With a Renal Tumor Response|Response is defined as the number of patients who experience a disease response (complete response (CR) or partial response (PR) of renal tumors)per RECIST criteria. CR is the disappearance of all target lesions. PR is at least a 20% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. See the protocol Link module for the full criteria if desired.|12 weeks|8 patients were evaluable (received at least one dose of drug and had a follow up scan).||participants|||Number
174707|NCT00088218|Primary|Number of Participants With Response|"Participant responses are categorized as 'Complete Remission,' Complete Remission, No Platelet Recovery,' 'No Response.'~Complete Remission: Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count > 1.0 x 109/L and platelet count > 100 x 109/L, and normal bone marrow differential (< 5% blasts); Complete Remission, No Platelet Recovery: Peripheral blood and bone marrow results as for CR, but with platelet counts of < 100 x 109/L.~Blood draws once a week until remission then every 2 to 8 weeks during therapy."|Every 2 to 8 weeks|All treated subjects.||Participants|||Number
174708|NCT00088166|Secondary|Number of Patients Who Discontinued Study Drug Prior to the End of Week 5|Numbers of patients who discontinued prior to the Week 5 assessment|Prospective|Intent to Treat population||participants|||Number
174709|NCT00088166|Secondary|Maximum Percent Reduction in Dexamethasone Usage Relative to Baseline Achieved During the Study|The maximum reduction in dexamethasone usage at any time during the study. Dexamethasone dosage was assessed at Weeks 0, 2, 5, 8, 12 and 16.|Prospective|Intent to Treat population; baseline observation carried forward||Percent dexamethasone dose reduction||Standard Deviation|Mean
174710|NCT00088166|Secondary|Change From Baseline in Myopathy Assessment Results at Week 12 (or Early Study Drug Discontinuation) and Week 16 (or 4-week Follow-up Visit)|Myopathy, using Kendall Myopathy Scale, was assessed at Baseline, Week 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up). The Kendall Myopathy Scale is a 10 point scale where 10 represents holding test position against strong pressure (best) and 0 represents no contraction palpable (worst).|Prospective|||Scores on a scale||Standard Deviation|Mean
174711|NCT00088166|Secondary|Change From Baseline in the FACT-Br Quality of Life Results|The FACT-Br Quality of Life Questionnaire was self-administered at Baseline, Weeks 5 and 12 (or upon Early SDD), and at the post-treatment 4-week follow-up visit (Week 16 and/or any unscheduled 4-week Follow-up).FACT-Br is a reliable and valid 50-item measure that includes FACT-G (27 items) and a brain subscale (23 items) to assess health-related quality of life in brain tumor patients. Each inventory question is scored from 0 (worst possible QOL) to 4 (best possible QOL)|Prospective|Intent to Treat; LOCF||Scores on a scale||Standard Deviation|Mean
174726|NCT00087685|Primary|Clinical Benefit Rate|Clinical benefit rate (CBR) is defined as the objective response rate plus the proportion of participants with prolonged stable disease (SD), e.g. nonprogression at 20 weeks. Objective response rate (ORR), determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST).|20 weeks|Of the 35 participants, four (4) were inevaluable due to inadequate treatment on trial.||percentage of participants||95% Confidence Interval|Number
174841|NCT00086580|Secondary|Kaplan-Meier Estimates of Overall Survival Time|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months.|Up to 6 years|Full analysis set||months||95% Confidence Interval|Median
174712|NCT00088166|Secondary|Change From Baseline in the Karnofsky Performance Score|"Change from Baseline in the Karnofsky Performance Score at Weeks 2, 5, 8, 12 and 16.The Karnofsky score runs from 100 to 0, where 100 is perfect health and 0 is death. Although practitioners occasionally assign performance scores in between standard intervals of 10 as follows:~100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of his personal needs.~50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent.~20 - Very sick; hospital admission necessary; active supportive treatment nec"|Prospective|Intent to Treat population||Scores on a scale||Standard Deviation|Mean
174713|NCT00088166|Secondary|Change From Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8 12 and 16 (or Early Discontinuation)|Change from Baseline in the 10-Item Neurological Examination Score at Weeks 2, 5, 8, 12 (or Early Study Drug Discontinuation), and 16 (or 4-week follow-up visit). Each item is scored from 0 (normal) to 4 (severely abnormal) except for speech (0-3) for a total range of 0-39. Total score for each patient was the sum of each item score. Change is calculated as the follow-up score minus the baseline score; a negative value indicates improvement.|Prospective|Intent to Treat population||Scores on a scale||Standard Deviation|Mean
174714|NCT00088166|Secondary|The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Who Continue to be Responders at Weeks 5 and 8|• The proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Weeks 5 and 8.|Prospective|Intent to Treat Population||participants|||Number
174715|NCT00088166|Secondary|Percent of Patients in Each Treatment Group Achieving 50% Reduction in Dexamethasone Usage Relative to Baseline by Week 2 Without Deterioration in Neurological Function as Measured by the 10-Item Neurological Exam and the KPS||Prospective|Intent to Treat Population||participants|||Number
174716|NCT00088166|Primary|The Proportion of Patients in Each Treatment Group Who Are Responders at Week 2 and Continue to be Responders at Week 5|"The primary efficacy endpoint was the proportion of patients in each treatment group who were Responders at Week 2 and who continued to be Responders at Week 5. Responders were defined as study patients who demonstrated the following:~50% or greater reduction in dexamethasone dose relative to Baseline~Overall 10-Item Neurological Examination Score unchanged or lower compared to Baseline~Karnofsky Score unchanged or increased relative to Baseline"|Prospective|Intent to Treat Population||participants|||Number
174717|NCT00088153|Primary|Change in Spine Bone Mineral Density Z-scores Over the Study Duration (18 Months)|"Bone density at the spine (lumbar 1-4 vertebrae) was measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 months, 12 months and 18 months.~The other primary outcome was the change in spine bone density Z-score from baseline to 18 months. The bone density Z-score is a standard deviation score that compares one's bone density to the mean for age and gender, and the Z-score, therefore, does not have any units. It is simply referred to as a Z-score. Change in bone density Z-score= [Bone density Z-score at 18 months- Bone density Z-score at baseline]"|Baseline and 18 months|||Z -scores||Standard Deviation|Mean
174718|NCT00088153|Secondary|Change in N-terminal Propeptide of Type 1 Procollagen (P1NP) Over the Study Duration (18 Months)|"P1NP is a surrogate marker of bone formation that is measured in serum. P1NP levels were measured at baseline, 6, 12 and 18 months.~A secondary outcome was the change in P1NP levels from baseline to 18 months: [P1NP at 18 months - P1NP at baseline). The unit is ng/ml"|Baseline and 18 months|The number of participants was determined based on our preliminary data. This analysis was based on completers only.||ng/ml||Standard Deviation|Mean
174719|NCT00088153|Primary|Percent Change in Spine Bone Density Over the Study Duration (18 Months)|"Bone density at the spine (lumbar 1-4 vertebrae) was measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 months, 12 months and 18 months.~The primary outcome was the percent change in bone density at the spine from baseline to 18 months. Areal bone density is measured as g/cm2. The unit of measure for the percent change in bone density is 'percent' Percent change in bone density= [[Bone density at 18 months- Bone density at baseline)*100/Bone density at baseline]%"|Baseline and 18 months|The number of participants was determined using power calculations based on preliminary data. For our primary longitudinal analysis, bone mineral density (BMD) changes were analyzed using a mixed model analysis of variance (intent-to-treat model). For secondary analysis, we examined BMD changes after controlling for age and weight changes.||Percent change||Standard Deviation|Mean
174720|NCT00087698|Secondary|Overall Survival Time|Number of months between the first dose date and the date of death as a result of any cause. Overall survival time calculated as (Date of death - First dose date + 1)/(365.25/12).|baseline to date of death from any cause|All participants who had undergone surgery.||months||Full Range|Mean
174721|NCT00087698|Secondary|Time to Progressive Disease|Number of months between the first dose date and the date of first disease progression or death as a result of any cause, whichever comes first.|baseline to measured progressive disease|All participants who had undergone surgery.||months||Full Range|Mean
174722|NCT00087698|Secondary|Time to Treatment Failure|Time to relapse (treatment failure) is measured in months and calculated as (Date of first surgery - Date of first relapse after surgery + 1)/(365.25/12). Time to relapse will be censored at the date of the last visit or start date of further anti-tumor therapy or intervention, whichever comes first.|baseline to stopping treatment|All participants who had undergone surgery.||months||Full Range|Mean
174723|NCT00087698|Secondary|Overall Tumor Response|The frequency of best overall tumor response summarized by response category. The best (unconfirmed) response recorded from the start of chemotherapy treatment until disease progression/recurrence, start of any further anti-tumor therapy, or time of surgery whichever comes first.|baseline to measured progressive disease|Intention to Treat analysis. All enrolled participants who were eligible for the treatment, whether or not they received the study drug.||participants|||Number
174724|NCT00087698|Secondary|The 1 and 2 Year Disease-Free Survival Rate (Percentage)|Kaplan-Meier estimates of the percentage of participants still alive at 1-year and 2-years, based upon the total number of participants who had surgery.|1 year and 2 years|All participants who had undergone surgery.||percentage of participants||95% Confidence Interval|Mean
175444|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
174727|NCT00087685|Primary|Number of Participants With Objective Response Plus Stable Disease Rate (CR + PR + SD)|Response determined by tumor assessments from radiological tests or physical examination using Response Evaluation Criteria In Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR): At least 30% decrease in sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Stable Disease (SD): Any condition not meeting the above criteria. The minimum duration for the SD will be 8 weeks. If the participant has stable disease at the time of the first radiographic evaluation, he/she will be considered to have stable disease. Progressive Disease (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|8 weeks|Of the 35 participants, four (4) were inevaluable due to inadequate treatment on trial.||participants|||Number
174728|NCT00087672|Primary|Efficacy of CC-5013 in Myelofibrosis|"Response evaluation, sustained for 2 weeks: Complete Remission (Neutrophil count between 1 to 10 x 10^9/L without peripheral blasts in blood or bone marrow); Partial Hematologic Response/Partial Remission (Increase in neutrophil by 50% + above 10^9/L for neutropenia); Hematologic Improvement (increase in Neutrophil count, hemoglobin, platelet count or reduction in blood/marrow blasts) or No Response.~If nine or < patients respond to therapy (response other than 'No Response'), therapy declared ineffective. However, if 11 or > patients respond to therapy, therapy considered efficacious."|3 - 4 Months for all patients; 24 months for responders|Intention to treat: After a total of 41 patients were enrolled in study, nine or more patients responded to the therapy, therapy declared effective.||Participants|||Number
174729|NCT00087646|Secondary|Percentage of Participants With Relapse After End of Treatment|The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.|Week 96 (Group A and C) and Week 72 (Group B and D)|ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
174730|NCT00087646|Secondary|Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response|Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.|Week 96 (Group A and C) and Week 72 (Group B and D)|ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
174731|NCT00087646|Secondary|Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)|The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (<50 IU/ML) and not quantifiable (<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.|At Week 12 and 24|ITT population included all participants randomized who received at least one dose of study medication.||IU/ML||95% Confidence Interval|Mean
174732|NCT00087646|Secondary|Percentage of Participants With >=2log Drop in HCV-RNA|Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.|At Week 12 and 24|ITT population included all the participants randomized who received at least one dose of study medication.||percentage of participants|||Number
174733|NCT00087646|Secondary|Percentage of Participants With Undetectable HCV-RNA|"The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 IU/mL measured >= 20 weeks after treatment end, ie, >=140 days after treatment end) are reported.~End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (<50 IU/mL) at study day of last dose of study medication (+/- 28 days)."|At Week 12, 24, 48 and EOT|ITT population included all participants randomized who received at least one dose of study medication.||percentage of participants|||Number
174734|NCT00087646|Secondary|Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)|SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|At Week 48 and Week 72|ITT population included all participants randomized who received at least one dose of study medication.||participants|||Number
174735|NCT00087646|Secondary|Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)|SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|At Week 48 and Week 72|ITT population included all participants randomized who received at least one dose of study medication.||participants|||Number
174736|NCT00087646|Primary|Number of Participants With Sustained Virological Response Rate|Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.|Up to 72 weeks (Group A) and 48 weeks (Group D)|Intent-to-treat analysis population (ITT) included, all participants randomized who received at least one dose of study medication.||participants|||Number
174737|NCT00087633|Secondary|Summary of Virologic Response|Rapid virologic responder (RVR): undetectable HCV-RNA at Week 4; complete early virologic responder (cEVR): undetectable HCV-RNA at Week 12; partial early virologic responder (pEVR): ≥2 log10 drop from baseline in HCV-RNA but positive at Week 12; early virologic responder (EVR): undetectable HCV-RNA or ≥2 log10 drop from baseline in HCV-RNA at Week 12; 24 weeks negative: undetectable HCV-RNA at Week 24; 48 weeks negative: undetectable HCV-RNA at Week 48; sustained virologic response (SVR): undetectable HCV-RNA at 24 weeks after the end of treatment.|After 4, 12, 24 and 48 weeks of therapy, and 24 weeks of follow-up|ITT population||participants|||Number
174738|NCT00087633|Primary|Percentage of Patients With Histologically-confirmed Recurrence of Hepatitis C Virus (HCV)|"Histologically-confirmed recurrence of HCV defined as Batts-Ludwig inflammation grade ≥3 and/or fibrosis stage ≥2.~Inflammation(Grade): 0 No Activity,1 Minimal,2 Mild,3 Moderate,4 Severe.~Fibrosis (Stage): 0 No fibrosis, Normal; 1 Portal fibrosis; 2 Periportal fibrosis or rare portal septa; 3 Septal fibrosis, Fibrous septa with architectural distortion, no obvious cirrhosis; 4 Cirrhosis."|120 weeks postrandomization|Intent-to-treat population||percentage of participants|||Number
174739|NCT00087607|Secondary|Weekly AUC for IFN Concentrations for Pegasys and PEG-Intron Estimated by Population Pharmacokinetic Modeling|The estimation of weekly AUC for IFN concentrations for Pegasys and PEG-Intron was planned through population pharmacokinetic modeling. A population pharmacokinetic method deals with modelling in a cohort which has many participants (usually more than 40). The estimation of weekly AUC for IFN concentrations for Pegasys and PEG-Intron was planned to be studied in the population rather than the individuals in Peginterferon alfa-2a + Ribavirin and Peginterferon alfa-2b + Ribavirin groups.|Up to Week 8|The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). This outcome measure was not analyzed as no data were collected for any of the participants in this study.|||||
174740|NCT00087607|Secondary|Percentage of Participants With Each of the Identified HCV Quasispecies at Baseline and Weeks 1, 4, 8, and 12|The determination of evolution of HCV quasispecies in participants was planned through analyzing viral sequences in serum samples drawn at baseline and at Weeks 1, 4, 8, and 12 if HCV RNA tests were positive and if the levels were sufficient to do the analysis.|Baseline, Weeks 1, 4,8, and 12|The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). This outcome measure was not analyzed as no data were collected for any of the participants in this study.|||||
174741|NCT00087607|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.|Up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).||participants|||Number
174742|NCT00087607|Secondary|Area Under the Curve for Interferon in the Frequent-Sampling Cohort|Area Under the Curve (AUC) for Interferon (IFN) for Week 1 and Week 8 in the frequent-sampling cohort were calculated using the trapezoidal rule.|Week 1 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants assessed for AUC for Interferon for specified time point.||week*pg/mL||Standard Deviation|Mean
174743|NCT00087607|Secondary|Mean Trough Interferon Concentrations at Each Week|The weekly Interferon (IFN) concentrations were calculated using the trapezoid rule. The trough IFN concentration was analyzed using an enzyme-linked immunosorbent assay (ELISA), with limits of quantification of 250 picograms per milliliter [pg/mL] for Pegasys and 150 pg/mL for PEG-Intron respectively.|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.||pg/mL||Standard Error|Mean
174744|NCT00087607|Secondary|Number of Participants With Marked Abnormalities in Thyroid Function Tests|Values outside the marked reference ranges for thyroid function test parameters that represent a defined, clinically relevant change from baseline are considered marked thyroid function test abnormalities. Roche’s standard reference ranges for thyroid function test parameters were used for the analysis. The thyroid function parameters with marked abnormalities were triiodothyronine (T3) (RR is 1.20 - 3.00 nanomole/liter [nmol/L]), thyroxine (T4) (RR is 51 – 154 nmol/L) and thyroid stimulating hormone (TSH) (RR is 0.0 - 5.0 milliunits per liter [mU/L]). Summary data of number of participants with only marked abnormalities in thyroid function tests are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).||participants|||Number
174745|NCT00087607|Secondary|Number of Participants With Marked Biochemical Test Abnormalities|Values outside the marked RR for biochemical test parameters that represent a defined, clinically relevant change from baseline are considered marked biochemical test abnormalities. Roche’s standard RR for biochemical parameters were used for this analysis. The biochemical test parameters with marked abnormalities were alanine aminotransferase (ALAT) (RR is 0 – 30 units per liter [U/L]), aspartate aminotransferase (ASAT) (RR is 0 – 25 U/L), gamma-glutamyl transferase (GGT) (RR is 0 – 60 U/L), total bilirubin (RR is 0 – 17 micromole/liter [umol/L]), creatinine (RR is 0 – 133 umol/L), total protein (RR is 60 – 80 g/L), triglycerides (RR is 0.45 - 1.70 millimole/liter [mmol/L]), chloride (RR is 100 – 108 mmol/L), potassium (RR is 3.5 - 5.0 mmol/L), sodium (RR is 133 – 145 mmol/L), calcium (RR is 2.10 - 2.60 mmol/L), random glucose (RR is 3.89 - 7.83 mmol/L), uric acid (140 – 500 umol/L). Summary data of number of participants with only marked biochemical test abnormalities are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).||participants|||Number
174969|NCT00084838|Other Pre-specified|Grade 3-4 Hepatic Events|All Grade 3-4 Hepatic events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174746|NCT00087607|Secondary|Number of Participants With Marked Hematologic Abnormalities|The values outside the marked reference range for any hematology parameter that represents a defined, clinically relevant change from baseline are considered marked hematology abnormalities. The Roche standard reference ranges for the hematology parameters for which subjects had marked abnormalities were hematocrit [(RR) is 0.42 - 0.52 (fraction)], hemoglobin (RR is 13.0 - 18.0 gram/deciliter), platelets (RR is 150 – 450 10^9 cells/L), white blood cells (WBC) (RR is 4.3 - 10.8 10^9 cells/L), basophils (RR is 0.00 - 0.15 10^9 cells/L), lymphocytes (RR is 1.50 - 4.00 10^9 cells/L), monocytes (RR is 0.20 - 0.95 10^9 cells/L), neutrophils (RR is 1.83 - 7.25 10^9 cells/L), prothrombin time (PT) (RR is 9 – 13 seconds), partial thromboplastin time (Partial Throm.) (Time) (RR is 25.0 - 38.0 seconds) and PT International normalized ratio (INR) [RR is 0.70 - 1.30 (ratio)]. Summary data of number of participants with only marked hematology abnormalities are presented.|Baseline, up to Week 12|The analysis population was the Safety Population. The Safety Population included all participants who were randomized, received at least one dose of study medication (PEG-IFN or ribavirin), and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, or physical examination finding).||participants|||Number
174747|NCT00087607|Secondary|Percentage of Participants With Undetectable HCV RNA (< 60 International Units/Milliliter) at Each Visit|The viral load was determined quantitatively and qualitatively by HCV-polymerase chain reaction (PCR). Qualitative viral titers will be assessed by Roche amplicor HCV Monitor® test v2.0 (< 600 IU/mL). The virological response was determined as the percentage of participants with undetectable HCV RNA at each week. A <60 IU/mL HCV-RNA was measured by amplicor PCR assay.|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).||percentage of participants||95% Confidence Interval|Number
174748|NCT00087607|Secondary|Percentage of Participants With a ≥ 2-log10 Decrease or Undetectable (< 60 International Units Per Milliliter) HCV RNA at Each Visit|The virological response was determined as the proportion/percentage of participants with a ≥ 2-log10 decrease or undetectable HCV RNA at each week. Detection of >= 2-log10 decrease of <60 IU/mL HCV-RNA was done by amplicor PCR assay at each week. Detection of >=2-log10 decrease or undetectable HCV RNA at Week 12 was considered an early virological response (EVR).|From Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).||percentage of participants||95% Confidence Interval|Number
174749|NCT00087607|Secondary|Weekly Viral Absolute Area Under the HCV RNA Curve Estimated in the Frequent-sampling Cohort for Weeks 1 and 8|The area under the HCV-RNA curve (HCV AUC) was defined as the area under the polygonal line defined by the HCV RNA values from the beginning of the window to the end of the window. For the frequent-sampling cohort, HCV AUCs over 7 days were calculated for Weeks 1 and 8, with intervals calculated beginning at the dose after which the frequent sampling began (different from the 7-day calendar period used for other AUC calculations). The AUCs for Weeks 1 and 8 in the frequent-sampling cohort (Sparse samples [SS] and frequent samples [FS]) were calculated using the trapezoidal rule.|Week 1 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.||log (IU*week/mL)||Standard Deviation|Mean
174750|NCT00087607|Secondary|Cumulative Viral Absolute Area Under the HCV RNA Curve Minus Baseline Averaged Over the 12-week Period|The area under the HCV-RNA curve (HCV AUC) was calculated for each week as the area under the polygonal line defined by the HCV RNA values from the beginning of the window to the end of the window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The weekly AUCMB was calculated by subtracting the Week −1 HCV AUC (i.e., baseline) from the weekly HCV AUC. The HCV AUCMB to Week 12 was the sum of the 12 weekly HCV AUCMBs divided by the time (12 weeks).|Up to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).||log10 IU/mL||Standard Deviation|Mean
174751|NCT00087607|Secondary|Mean Value of Area Under the HCV-RNA Curve Minus Baseline From Week 1 to Week 12|The HCV AUC was calculated for each week as the area under the polygonal line defined by the HCV RNA values from the beginning of the time window to the end of the time window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The weekly AUCMB was calculated by subtracting the Week −1 HCV AUC (i.e., baseline) from the weekly HCV AUC and presented.|Baseline, Week 1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.||log (IU*week/mL)||Standard Deviation|Mean
174752|NCT00087607|Secondary|The Area Under the HCV-RNA Curve Estimated From the Two Adjacent Pre-dose Assessments at Each Week|The area under the HCV-RNA curve (HCV AUC) was defined as the area under the polygonal line defined by the HCV RNA values from the beginning of the time window to the end of the time window. Each of these areas was a sum of one or more trapezoids determined from the concentrations over the 7-day interval. The HCV AUC to Week 12 was the sum of the 12 weekly HCV AUCs divided by the time (12 weeks). Summary of weekly HCV AUC values estimated from the two adjacent pre-dose assessments are presented.|From Week -1 to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.||log 10 IU/mL||Standard Deviation|Mean
174753|NCT00087607|Secondary|Weekly Viral Load Assessed at Drug Trough|The viral load was determined quantitatively and qualitatively by HCV-PCR. HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 IU/mL, changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The viral load levels in the serum at baseline and for each week, were expressed in terms of a logarithmic scale with base 10, and averaged for all participants.|Baseline, up to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). The “n” represents the number of participants analyzed at a specified time point.||log (IU/mL)||Standard Deviation|Mean
174754|NCT00087607|Secondary|Mean Change From Baseline in Viral Load (log10 Reduction) at Week 4 and Week 8|The viral load was determined quantitatively and qualitatively by HCV-PCR. HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 IU/mL, changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The average value of the difference between viral load levels in the serum from baseline to week 4 and week 8, expressed in terms of a logarithmic scale with base 10 are presented.|Baseline, Week 4 and Week 8|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin).The “n” represents the number of participants analyzed at a specified time point.||log (IU/mL)||Standard Error|Mean
174755|NCT00087607|Primary|Change From Baseline in Viral Load (log10 Reduction) at Week 12|The viral load was determined quantitatively and qualitatively by Hepatitis C virus (HCV)-polymerase chain reaction (PCR). HCV RNA was measured qualitatively using the Roche amplicor PCR assay (lower limit of detection 60 international units per milliliter (U/mL), changed from 50 IU/mL with amendment B) and quantitatively using the Roche amplicor HCV monitor® test v2.0 (lower limit of quantification 600 IU/mL). Log transformations were performed for HCV RNA, and the analyses were done on a log10 scale. The average value of the difference between viral load levels in the serum from baseline to Week 12, expressed in terms of a logarithmic scale with base 10, are presented.|From Baseline to Week 12|The analysis population was ITT Population. The ITT Population included all participants who were randomized and received at least one dose of study medication (PEG-IFN or ribavirin). Data using ITT Population are presented below.||log (IU/mL)||Standard Error|Mean
174756|NCT00087594|Secondary|Number of Participants With Any Adverse Events (AEs), Any Serious Adverse Events (SAEs), and Study Discontinuation|An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. Reason for discontinuation was categorized as safety and non-safety, where safety reasons included abnormality of laboratory tests, AEs, and death; and non-safety reasons included insufficient therapeutic response, early improvement, violation of selection criteria at entry, other protocol violation, refused treatment, failure to return and other. Participants who discontinued the study with any reason were recorded.|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
174757|NCT00087594|Secondary|Number of Participants With Marked Laboratory Abnormalities (Biochemistry)|"Laboratory values falling outside the marked reference range as defined by Roche's International Guideline for the Handling and Reporting of Laboratory Data”, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal."|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
174758|NCT00087594|Secondary|Number of Participants With Marked Laboratory Abnormalities (Hematology)|"Hematology included hematocrit (fraction), hemoglobin, platelets count, Red blood cells (RBC), White blood cell (WBC), eosinophils, lymphocytes, monocytes, neutrophils, Partial Thromboplastin time (PTT), Prothrombin Time International Normalized Ratio (PT INR). Laboratory values falling outside the marked reference range as defined by Roche's International Guideline for the Handling and Reporting of Laboratory Data”, and were clinically relevant change from baseline were considered marked laboratory abnormalities. It was reported as low or high abnormal."|Up to 24 weeks post treatment (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
174759|NCT00087594|Secondary|Number of Participants With Abnormal Vital Signs|Vital Signs included systolic blood pressures (SBP), diastolic blood pressures (DBP), and pulse rate (PR). Abnormal vital signs were reported as low or high abnormal. It was defined as < 85 mm Hg or > 180 mm Hg with a change from baseline of > 20%; DBP as > 110 mm Hg with a change from baseline of > 20%; and PR as < 50 bpm and > 120 bpm with a change from baseline of > 20%.|Up to 24 weeks of treatment-free follow-up visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
174760|NCT00087594|Secondary|Number of Participants With Compliance to the Prescribed Treatment Regimen|Participants with compliance to the prescribed treatment regimen for peginterferon alfa-2a and ribavirin was reported. Compliance was calculated as (total cumulative dose taken) / (total cumulative original dose prescribed for the entire study) x 100. Total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (48*7) for G1, total treatment duration = Maximum doses of peginterferon alfa-2a and ribavirin in days / (24*7) for G2/3.|Up to Week 24 for G 2/3; up to Week 48 for G1|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
174970|NCT00084838|Other Pre-specified|Grade 3-4 Muscloskeletal Events|All Grade 3-4 Muscloskeletal events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174761|NCT00087594|Secondary|Mean Absolute Scores for Hepatitis Quality-of-Life Questionnaire (HQLQ) at EOT (Week 24/48) Visit and 24 Weeks After EOT Visit|The HQLQ is a multiple-choice questionnaire includes the eight individual qualify-of-life scales of the Medical Outcomes Study 36-item Short-form Health Survey as: Social functioning (SF), role limitations due to emotional problems (RE), vitality (VT), general mental health (MH), physical functioning (PF), role limitations due to physical problems (RP), freedom from bodily pain (BP), and general health (GH). In addition, two other generic scales (positive well-being [PWB] and health distress [HD]) and two hepatitis-specific scales (limitations because of chronic hepatitis C [HLIM] and health distress because of chronic hepatitis C [HHD]) were included. Scores were scaled to a 0 to 100 range, with 0 = bad and 100 = good. A higher score indicates an improvement.|Baseline (Day -30 to -1), 24 weeks after EOT visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||units on a scale||Standard Error|Mean
174762|NCT00087594|Secondary|Number of Participants With Degrees of Depression as Defined by the BDI-II Score|Participants with degrees of depression as defined by the BDI-II Score were reported. BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Up to Week 72|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
174763|NCT00087594|Secondary|Mean Change From Baseline in BDI-II Score to EOT (Week 24/48) and EOS (Week 48/72) Visits|BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1)|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||units on a scale||Standard Error|Mean
174764|NCT00087594|Secondary|Mean Absolute Score of Beck Depression Inventory, Second Edition (BDI-II)|BDI-II is 21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. Degrees of depression defined by the total BDI-II score as: minimal (0 to 13), mild (14 to 19), moderate (20 to 28), and severe depression (>= 29). Higher scores reflective of greater severity (worse outcome).|Baseline (Day -30 to -1), EOT visit (Week 24 for G2/3 and Week 48 for G1), and end of study (EOS) visit (Week 48 for G2/3 and Week 72 for G1).|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||units on a scale||Standard Error|Mean
174765|NCT00087594|Secondary|Number of Participants With > =2 Log Drop From Baseline or Undetectable HCV-RNA (<10 IU/mL) at Week 12||Week 12|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.||participants|||Number
174766|NCT00087594|Secondary|Number of Participants With Biochemical Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 and 24 Weeks After Treatment Completion|Biochemical response is defined as the number of participants with a normal serum alanine aminotransferase (ALT) concentration (i.e., ALT < 30 U/L). EOT for G1 was Week 48 and for G2/3 was Week 24.|Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.||participants|||Number
174767|NCT00087594|Secondary|Number of Participants With Virological Response Rate at Weeks 12, 24, and 48 (G1 Only) During Treatment and at 12 Weeks After Treatment Completion|Virological Response Rate is defined as the number of participants with undetectable HCV-RNA (< 10 IU/mL). Treatment completion (end of treatment [EOT]) for G1 was Week 48 and for G2 or 3 was Week 24.|Weeks 12, 24, and 48 for G1 and Weeks 12 and 24 for G2/3; 12 and 24 weeks after EOT for G1 (Weeks 60 and 72) and G2/3 (Weeks 36 and 48)|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.||participants|||Number
174768|NCT00087594|Secondary|Number of Participants With Sustained Virological Response (SVR) Rate at 24 Weeks Post Treatment (Week 48 for G2/3 and Week 72 for G1)|SVR is defined as the number of participants with undetectable HCV-RNA (< 10 international unit per milliliter [IU/mL]) at 24 weeks post treatment completion.|Week 48 for G2/3 and Week 72 for G1|ITT Population included all enrolled participants who received at least one dose of study medication. n = number of participants at indicated time points for each arm.||participants|||Number
174769|NCT00087594|Primary|Number of Participants With Treatment Completion Rate (TCR)|TCR is defined as the number of participants who completed the prescribed duration of the study treatment. TCR for G1 participants is defined as the number of participants who had a missing value or >= 2-log10 decrease in Hepatitis C virus-ribonucleic acid (HCV RNA) at Week 12 and completed 48 weeks of study treatment or had a < 2-log10 decrease from baseline at Week 12 and completed at least 12 weeks of study treatment. TCR for G2/ 3 participants is defined as the number of participants who completed 24 weeks of study treatment.|Up to 24 weeks for G2/3; up to 48 weeks for G1|Safety Population included all participants who received at least one dose of study treatment and have at least one post-baseline safety assessment (adverse event, laboratory/vital sign, physical examination; Beck Depression Inventory; Hepatitis Quality-of-Life Questionnaire). n = number of participants at indicated time points for each arm.||participants|||Number
174770|NCT00087568|Secondary|Mean Score for Overall Local Injection Site Reaction|Local injection-site reactions were to be given an overall assessment based on pain or discomfort as Grade 0 for no pain or discomfort, Grade 1 for mild tenderness at the injection site, Grade 2 for moderate pain without limitation of usual activities, Grade 3 for severe pain requiring prescription non-topical analgesics or limiting usual activities, Grade 4 for a reaction that resulted in a new hospitalization, prolongation of hospitalization, death, or a persistent or significant disability/incapacity, or was life threatening or medically significant. Adverse events related to the injection site (injection site erythema, hematoma, pain, rash, or reaction) were reported. All of these events were reported as resolved without sequelae.|Baseline (Week 0), Week 4, 12, 24, 36, 48 and 60|Safety Population included all enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory, vital sign, or physical examination finding, BDI-II score, or FSS score). 'n' = number of participants available at the time of assessment.||Units on a scale||Standard Deviation|Mean
174771|NCT00087568|Secondary|Number of Participants With Abnormal Vital Signs|"Abnormal vital signs were defined as~Systolic blood pressure (BP) below 85 mm Hg or above 180 mm Hg with a change from baseline of > 20%~Diastolic BP above 110 mm Hg with a change from baseline of > 20% where systolic and diastolic BP were pressure exerted by blood on the walls of blood vessels during left ventricular systole and diastole respectively.~Pulse rate below 50 beats per minute and above 120 beats per minute, with a change from baseline of > 20%, where pulse represents the palpation of heartbeat"|From screening (Day -21 to Day -1) to Week 84|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score).||Participants|||Number
174772|NCT00087568|Secondary|Number of Participants With Marked Laboratory Abnormalities|Analysis was performed for hematology, clinical chemistry, thyroid function, and urinalysis. Normal ranges of the parameters were: Haematocrit (fraction): 0.37 - 0.49, Haemoglobin (g/L): 130 - 180 , Platelets (G/L): 150 - 350, White blood cell (G/L): 4.5 - 11.0, Lymphocytes (G/L): 1.00 - 4.80, Neutrophils (G/L): 1.80 - 7.70, Prothrombin Time in Seconds (sec): not defined, Prothrombin Time, normalized (ratio): 0.70 - 1.30, Partial thromboplastin Time (sec): 22.1 - 34.1, Aspartate transaminase (AST) or serum glutamate oxaloacetate transaminase (SGOT) in IU/L: 0 - 40, Alkaline Phosphatase (IU/L): 0 - 115, ALT or serum glutamate pyruvate transaminase (SGPT) in (IU/L): 0-55, Total Bilirubin (umol/L): 0 -17, Thyroxine (T4) (nmol/L): 58 -140, Thyroid-stimulating hormone (TSH, [U/mL]): 0.0 - 5.0, Triglycerides (mmol/L): 0.45 - 1.69, Phosphate (mmol/L): 0.84 - 1.45, Uric Acid (umol/L): 214 - 506|Up to Week 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory, vital sign, or physical examination finding, BDI-II score, or FSS score). 'n' = number of participants available at the time of assessment.||participants|||Number
174773|NCT00087568|Secondary|Number of Participants With Individual Flu-like Symptom|Participants were asked to complete a flu-like symptom questionnaire at screening, study baseline, and at all subsequent scheduled visits. The “yes/no” questionnaire evaluated the incidence of headache, fever, myalgia, and chills. If a participant answered “yes” to the question “Has the patient experienced any flu-like symptoms since the last visit?” all among headache, fever, muscle aches (myalgia), and chills that applied were to be marked. If any of the experienced symptoms was newly reported or had worsened, a corresponding adverse event was to be reported.|Baseline (Week 0); Weeks 12, 36, 60 and 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination data, BDI-II score, or FSS score). n = number of participants available at the particular time of assessment.||Participants|||Number
174774|NCT00087568|Secondary|Mean Score of Fatigue Severity Over Time|The Fatigue severity score (FSS) scale has a series of questions designed to assess tiredness, lack of energy, or total body give-out. Participants were to react to nine statements regarding fatigue over the previous 2 weeks, each on a scale (1 = completely agree, 7 = completely disagree). The FSS is the average of the scores on the 9 questions; ranging from 1-7, with lower scores indicating less fatigue. In addition, participants were to react to how much fatigue they had in the past 2 or 4 weeks by marking on a visual analogue scale labelled at one end with “no fatigue” (‘0’ being the best) and at the other end with “greater fatigue” (‘100’ being the worst). Longer distance on the scale from “no fatigue” indicated “greater fatigue”. FSS values are presented based on questionnaire and visual analog scale.|Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84|Safety Population included all the enrolled participants who received at least one dose of study medication and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination finding, or FSS score). n = number of participants available at the particular time for assessment.||Units on a scale||Standard Deviation|Mean
174775|NCT00087568|Secondary|Mean Score of Beck Depression Inventory Over Time|The Beck Depression Inventory (BDI-II) is a questionnaire with groups of statements in which the patient is asked to select the statement that most clearly describes the way he/she has felt in the past two weeks, including today. The score for each group is tallied and the ranges of scores are used as guidelines for measuring the degree of depression. For this study, scores are defined as follows: 0 to 15 as minimal, 16 to 21 as mild, 22 to 30 as moderate, and 31 to 63 as severe. The questionnaire was in two areas (changes in sleeping pattern and changes in appetite), selections 1, 2, and 3 contained options for both more and less with respect to the area of interest. Four statements (labelled 0, 1, 2, and 3) were offered that described the area of interest, with 0 indicating no effect and 3 indicating the worst effect. The individual area scores were summed to provide a total score.|Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84|Safety Population included all enrolled participants who received at least one dose of study drug and had at least one post-baseline safety assessment (a clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score). n = number of participants available at the particular time for assessment.||Units on a scale||Standard Deviation|Mean
174971|NCT00084838|Other Pre-specified|Grade 3-4 Constitutional Events|All Grade 3-4 Constitutional events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174776|NCT00087568|Secondary|Number of Participants With Serious Adverse Events and Adverse Events|An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An adverse event could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions that worsened during the study were also to be reported as adverse events. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 84|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment (defined as clinical adverse event, laboratory or vital sign data, physical examination finding, BDI-II score, or FSS score).||Participants|||Number
174777|NCT00087568|Secondary|Number of Participants With Normal Serum Alanine Transaminase Levels Over Time|The number of participants with serum alanine transaminase (ALT) concentration within the normal range at each time point assessed. Upper limit of normal serum ALT for men is 43 International units per liter (IU/L) and for women is 34 IU/L.|Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84|ITT Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).||Participants|||Number
174778|NCT00087568|Secondary|Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time|Sustained virological response (SVR) is defined as undetectable Hepatitis C virus-ribonucleic acid (HCV RNA)(<60 International units per milliliter) or HCV RNA for >=2-log10 decrease in viral titre, 24 weeks after the end of treatment. A participant was classified as non-responder (SVR not achieved) if HCV RNA was detectable at the completion of antiviral treatment, at Week 24 post or at any time between Week 24 and completion of antiviral treatment. HCV RNA measured prior to or on the date of the first dose of Pegasys plus ribavirin was used as the baseline in all HCV RNA analyses.|Weeks 4, 12, 24, 36, 48, 60, and 84|Intent to treat (ITT) Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin).||Participants|||Number
174779|NCT00087568|Primary|Number of Pegasys and Ribavirin Therapy Completers|Therapy completers were defined as all participants who had demonstrable viremia after 12 weeks of Pegasys plus ribavirin therapy (who were to be discontinued for lack of efficacy), non-tolerators who completed 36 weeks of Pegasys plus ribavirin therapy, and non-responders who completed 60 weeks of Pegasys plus ribavirin therapy. Study completers included all participants who completed the planned treatment period (36 weeks for non-tolerators and 60 weeks for non-responders) and the 24-week treatment-free follow-up period and participants in either group who were prematurely discontinued per protocol due to insufficient therapeutic response at Week 12.|36 weeks for Non-Tolerators and 60 weeks for Non-Responders|Safety Population included all enrolled participants who received at least one dose of study medication (Pegasys or ribavirin) and had at least one post-baseline safety assessment which defined as clinical adverse event, laboratory or vital sign data, physical examination finding, Beck Depression Inventory (BDI-II), or Fatigue severity score (FSS).||Participants|||Number
174780|NCT00087555|Primary|The Primary Outcome Measure Was a Composite of Changes From Baseline in Three Co-primary Self Report Measures: Pain Visual Analog Scale (PVAS, Electronic Diaries), Fibromyalgia Impact Questionnaire (FIQ), and Patient Global Impression of Change (PGI-C).|"The percentage of participants who met all 3 of the following criteria:~Reduction of >=20% from baseline to week 8 in both PVAS & FIQ total score and PGI-C response of very much better or much better. Analysis was based on LOCF (Last Observation Carried Forward) data. The PVAS ranges from 0 (no pain) to 100 (worst imaginable pain). The FIQ ranges from 0 (best function) to 100 (worst function). PGI-C is a 7 point likert scale measuring change in the participant's fibromyalgia symptoms that ranges from very much worse to very much better"|Baseline to week 8|||Percentage of Participants|||Number
174781|NCT00087529|Secondary|Change From Baseline to Week 96 in Brain Volume on MRI Scan|Scheduled MRI scans of the brain and cervical spinal cord were performed with and without gadolinium contrast at Screening and Week 6, and without gadolinium at Weeks 48, 96, and 122 and/or upon early termination. The total brain volume was documented at Baseline and at visits occurring during Weeks 48 and 96. Missing Week 96 values were imputed using a LOCF approach, while participants with missing Baseline values were excluded. The change in brain volume was calculated as [volume at Week 96 minus volume at Baseline] and expressed in cubic centimeters (cm^3).|At Baseline and Week 96|ITT Population. Participants with missing Baseline values were excluded.||cm^3||Full Range|Median
174782|NCT00087529|Secondary|Change From Baseline to Week 96 in Total Volume of Transverse Relaxation Time (T2) Brain Lesions on Magnetic Resonance Imaging (MRI) Scan|Scheduled T2-weighted MRI scans of the brain and cervical spinal cord were performed with and without gadolinium contrast at Screening and Week 6, and without gadolinium at Weeks 48, 96, and 122 and/or upon early termination. The total volume of T2 (ie, hyperintense) brain lesions at each visit was documented. Missing Week 96 values were imputed using a last observation carried forward (LOCF) approach, while participants with missing Baseline values were excluded. The change in T2 lesion volume was calculated as [volume at Week 96 minus volume at Baseline] and expressed in cubic millimeters (mm^3).|At Baseline and Week 96|ITT Population. Participants with missing Baseline values were excluded.||mm^3||Full Range|Median
174783|NCT00087529|Primary|Percentage of Participants With CDP|Disease progression was assessed using the EDSS, a disability scale that ranges from 0 to 10, where higher scores represent increased disability. Progression was defined as either an increase of ≥1 point from a Baseline EDSS score within 2.0 to 5.5 points, or an increase of ≥0.5 points from a Baseline EDSS score >5.5 points, for which the change was not attributable to another etiology. Repeat assessment to determine CDP must have occurred at a regularly scheduled visit at least 12 weeks after initial progression; those who discontinued treatment early without confirmatory EDSS assessment were considered as having CDP. The percentage of participants with CDP was calculated as [number of participants meeting the above criteria divided by the number analyzed] multiplied by 100.|96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)|ITT Population.||percentage of participants|||Number
174784|NCT00087529|Primary|Time to Confirmed Disease Progression (CDP)|Disease progression was assessed using the Expanded Disability Status Scale (EDSS), a disability scale that ranges from 0 to 10, where higher scores represent increased disability. Progression was defined as either an increase of greater than or equal to (≥) 1 point from a Baseline EDSS score within 2.0 to 5.5 points, or an increase of ≥0.5 points from a Baseline EDSS score greater than (>) 5.5 points, for which the change was not attributable to another etiology. Repeat assessment to determine CDP must have occurred at a regularly scheduled visit at least 12 weeks after initial progression; those who discontinued treatment early without confirmatory EDSS assessment were considered as having CDP. Those who did not meet criteria for CDP, completed treatment with only initial progression, or received an exclusionary therapy were censored at last EDSS assessment. Time to CDP was the time from randomization to initial disease progression, estimated using Kaplan-Meier (KM) analysis.|96 weeks (from Screening to Week 96, and at least 12 weeks after initial progression)|ITT Population.||weeks||95% Confidence Interval|Median
174785|NCT00087516|Secondary|Change From Baseline in 2-hr PMG at Week 104|Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.|Weeks 0-104|The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||mg/dL||95% Confidence Interval|Least Squares Mean
174786|NCT00087516|Secondary|Change From Baseline in FPG at Week 104|Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.|Weeks 0-104|The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||mg/dL||95% Confidence Interval|Least Squares Mean
174787|NCT00087516|Secondary|Change From Baseline in A1C at Week 104|A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.|Weeks 0-104|The all-patients-treated population for Week 104 included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||Percent||95% Confidence Interval|Least Squares Mean
174788|NCT00087516|Secondary|Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24|Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||mg/dL||95% Confidence Interval|Least Squares Mean
174789|NCT00087516|Secondary|Change From Baseline in FPG at Week 24|Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||mg/dL||95% Confidence Interval|Least Squares Mean
174790|NCT00087516|Primary|Change From Baseline in A1C at Week 24|A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.|Weeks 0-24|The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method.||Percent||95% Confidence Interval|Least Squares Mean
174791|NCT00087490|Secondary|Number of Participants Using Medical Resources|Medical resources utilization included a daily log of the participants’ location in the hospital and outside of the hospital (non-hospital location), adjusted duration of stay (difference between duration of stay and the duration of discharge delay) and daily log of study drug dosing.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|Data was not analyzed for the primary reporting.||Participants|||Number
174792|NCT00087490|Secondary|Duration of Intravenous Therapy for mITT Population|Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. N(number of participants analyzed)=participants evaluable for the measure."||Days||Standard Error|Mean
174793|NCT00087490|Secondary|Duration of Intravenous Therapy for PP Population|Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|"PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit.N(number of participants analyzed) = participants evaluable for the measure."||Days||Standard Error|Mean
174794|NCT00087490|Secondary|Duration of Hospital Stay for mITT Population|Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.||Days||Standard Error|Mean
174825|NCT00086580|Secondary|Maximum Plasma Concentration (Cmax) of Fludarabine|Cmax is the maximum plasma concentration of fludarabine observed.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population||ng/mL||Standard Deviation|Mean
174795|NCT00087490|Secondary|Duration of Hospital Stay for PP Population|Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.|Baseline up to EOS (6 to 28 days after the last dose of study drug)|PP set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS visit unless declared failure prior to visit.||Days||Standard Error|Mean
174796|NCT00087490|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded using wound parameter score ranging from 0 to 3; “0= none, 1= mild, 2= moderate and 3= severe”.|EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)|mITT population included participants who received at least 1 dose of drug with appropriate diagnosis caused by MRSA. Here, 'n' signified participants who were evaluable and analyzed for specific clinical signs and symptoms.||Partcipants|||Number
174797|NCT00087490|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded by the sponsor using wound parameter score ranging from 0 to 3; “0= none, 1= mild, 2= moderate and 3= severe”.|EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)|PP set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen, satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days),observed outcome at EOS visit unless declared failure prior to the visit.Here,'n'=participants evaluable for specific clinical signs and symptoms.||Participants|||Number
174798|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).|EOT (within 72 hours of last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."||Percentage of participants|||Number
174799|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).|EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."||Percentage of participants|||Number
174800|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).|EOT (within 72 hours of last dose of study drug)|"PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."||Percentage of participants|||Number
174801|NCT00087490|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population|Microbiological outcome dichotomized to “success” (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and “failure” (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).|EOS (6 to 28 days after the last dose of study drug)|"PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."||Percentage of participants|||Number
174826|NCT00086580|Secondary|Area Under the Curve (AUC) of Fludarabine From (AUC 0-tau)|AUC (0-tau) is the area under the plasma concentration curve for fludarabine over the dosage interval (tau).|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population||ng*h/mL||Standard Deviation|Mean
174802|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population|CR evaluated at EOT visit as “success” (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown”: excluded from present analysis.|EOT (within 72 hours of last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."||Percentage of participants|||Number
174803|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population|CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as “success” (cure: resolution of clinical signs/symptoms of infection when compared to baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown” was excluded from present analysis.|EOS (6 to 28 days after the last dose of study drug)|"mITT population included participants who received at least 1 dose of drug with appropriate diagnosis and MRSA as pathogen.N(number of participants analyzed)= participants evaluable for the measure."||Percentage of participants|||Number
174804|NCT00087490|Secondary|Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population|CR evaluated at EOT visit as “success” (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown”: excluded from present analysis.|EOT (within 72 hours of last dose of study drug)|"PP (EOT)set:who received at least 1 dose of drug,with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria,adequate dosing(failure:2 full days of drug,success:4 full days),observed outcome at EOT visit unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."||Percentage of participants|||Number
174805|NCT00087490|Primary|Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population|Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as “success” (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); “failure”: persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; “unknown”: extenuating circumstances precluding classification to 1 of above. “Unknown” was excluded from present analysis.|EOS (6 to 28 days after the last dose of study drug)|"PP (EOS)set:who received at least 1 dose of drug, with appropriate diagnosis,MRSA as pathogen,satisfied all key inclusion/exclusion criteria, adequate dosing(failure:2 full days of drug, success:4 full days), observed outcome at EOS unless declared failure prior to visit.N(number of participants analyzed)=participants evaluable for the measure."||Percentage of participants|||Number
174806|NCT00087438|Secondary|Rates of Local Recurrence, Regional Recurrence, Disseminated Recurrence, Disease-free and Overall Survival at 2 Years||From the start of treatment to 2 years||||||
174807|NCT00087438|Secondary|Treatment-related Grade 3 or 4 Toxicity||From the start of treatment to end of follow-up||||||
174808|NCT00087438|Primary|Local Control at 2 Years|Local control is defined as absence of local failure. (Detailed criteria for local failure is too long to include here.)|From the start of treatment to 2 years|Eligible patients who started protocol treatment.||percentage of subjects||95% Confidence Interval|Number
174809|NCT00087152|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5= Fatal. Only adverse events that are possibly, probably or definitely related to study drug are reported.|Every 3 weeks while on treatment for up to 3 years.|Eligible participants who received any treatment.||Participants|||Number
174810|NCT00087152|Secondary|Progression-free Survival at 6 Months|Percentage of participants progression-free at 6 months. Progression-free survival (PFS) measured from date of registration to first observation of progressive disease (per RECIST criteria (V1.0)), death due to any cause, or symptomatic deterioration. Kaplan-Meier was used to estimate progression-free survival (PFS) at six months.|Six months|Eligible participants who received treatment.||percentage of participants||95% Confidence Interval|Number
174811|NCT00087152|Primary|Confirmed Response Rate (Complete and Partial)|Number of participants with confirmed complete or partial response. Confirmed response (complete and partial) per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (V1.0). Complete Response (CR) is complete disappearance of all measurable and non-measurable disease; no new lesions; no disease related symptoms; and normalization of markers and other abnormal lab values. Partial response (PR) applies only to patients with at least one measurable lesion. PR is greater than or equal to 30% decrease under baseline of the sum of longest diameter of all target measurable lesions; no unequivocal progression of non-measurable disease and no new lesions. Confirmed response is two or more objective statuses a minimum of four weeks apart documented before progression or symptomatic deterioration.|12 weeks|Eligible participants who received treatment.||participants|||Number
174812|NCT00087139|Secondary|Duration of Measurable Disease Response|Duration of measurable disease response was defined as the time from the date when measurement criteria were met for complete or partial response, whichever status was recorded first, until the first date that recurrent or progressive disease was objectively documented based on RECIST (Response Evaluation Criteria in Solid Tumors). Only patients with measurable disease response were included in this analysis.|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|Only patients with measurable disease response were included in this analysis.||Months||95% Confidence Interval|Median
174813|NCT00087139|Secondary|Duration of PSA Response|Duration of PSA response was defined as the time from the date of onset of PSA response until the date the criteria were met for PSA progression. Only patients with a PSA response were included in this analysis. The results were reported separately for 3 strata.|Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|If the regimen demonstrated a PSA response rate specified in the protocol, additional patients would be entered so the total number of eligible patients with measurable disease in each stratum is 25. But the PSA response related analysis was only done among the first cohort of patients, not including the additional patients with measurable disease.||Months||95% Confidence Interval|Median
174814|NCT00087139|Secondary|Proportion of Patients With Measurable Disease Response (Best Overall Response)|"Only patients with measurable disease were included in this analysis. The proportion of patients with measurable disease response (based on RECIST: Response Evaluation Criteria in Solid Tumors) was reported separately for 3 strata.~Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.~Objective response = CR + PR"|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|Only patients with measurable disease were included in this analysis.||proportion of participants||90% Confidence Interval|Number
174815|NCT00087139|Primary|Proportion of Patients With PSA Response|PSA response is defined as a decline from baseline value by >=50%, or normalization of PSA (PSA < 0.2 ng/lm), confirmed by a second measurement >= 4 weeks later. The proportion of patients with PSA response was reported separately for 3 strata. Additional patients accrued to this study were not included in this analysis.|Every 4 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-5 years from study entry|If the regimen demonstrated a PSA response rate specified in the protocol, additional patients would be entered so the total number of eligible patients with measurable disease in each stratum is 25. But the PSA response rate was only calculated among the first cohort of patients, not including the additional patients with measurable disease.||Proportion of participants||90% Confidence Interval|Number
174816|NCT00086996|Secondary|Progression-free Survival|measured from date of registration to time of first documentation of progression by Response Evaluation Criteria in Solid Tumors (RECIST), death, or last contact date.|0-3 years|eligible patients||months||95% Confidence Interval|Median
174817|NCT00086996|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|0-5 years|eligible patients||months||95% Confidence Interval|Median
174818|NCT00086996|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Up to 3 years|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any Common Terminology Criteria for Adverse Events (CTCAE) v3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
174819|NCT00086996|Primary|Pathological Complete Response|Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.|10-16 weeks after beginning study treatment|Eligible patients||participants|||Number
174820|NCT00086684|Secondary|Number of Responders Defined as Having at Least a Four Point Reduction in the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint|The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.|Baseline to Week 24|Intent-to-Treat (ITT) Analysis set||participants|||Number
174821|NCT00086684|Primary|Number of Responders Defined as Having at Least a 30% Reduction in the O’Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint|The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.|Baseline to Week 24|Intent-to-Treat (ITT) Analysis set||participants|||Number
174822|NCT00086619|Secondary|Change in Bone Mineral Density (BMD)|Percent change in BMD of the spine, femur, radius, and ulna, and subtotal body, calculated as 100*[(final - month 0)/month 0] in subjects who took study therapy for at least 12 months.|baseline and 18 months (12 months in 4 subjects)|Final BMD was measured after 18 months of study therapy in 48 subjects and measured after 12 months of study therapy in 4 others who thereafter dropped out prematurely. Of the latter 4, 3 were in the ascending dose arm and 1 was in the constant dose arm.||percent change||Standard Deviation|Mean
174823|NCT00086619|Primary|Changes in Indices of Bone Turnover|Change from month 0 (pre-treatment) baseline serum aminoterminal propeptide of type I collagen (PINP), osteocalcin (OC), and C-terminal telopeptide (CTX), expressed as an area under the curve (AUC). Each marker measurement result was multiplied by the corresponding subject-specific elapsed study time interval using the trapezoidal rule, and these products were summed to generate a subject-specific AUC (months*ng/ml) for the marker.|Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18.|Because this was a physiologic study evaluating the impact of stepwise increases in teriparatide, per protocol analysis was performed as was pre-specified in our analysis plan. Outcomes data were analyzed in women who remained on teriparatide throughout the first stepwise increase (i.e. until month 12 or later).||months*(ng/ml - baseline ng/ml)||Standard Deviation|Mean
174824|NCT00086580|Secondary|Participants With Minimal Residual Disease (MRD)|MRD negativity in this report was defined by the absence of tumor cells in bone marrow, using 4-color flow cytometry. MRD was assessed in participants with a clinical complete response (CR) or partial response (PR) without recovery of blood counts. MRD represents a very positive outcome.|up to 9 months|Full analysis set||participants|||Number
174827|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage III-IV|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage III or IV.|Up to 6 years|Full analysis set of participants with Rai Stage III or IV||months||95% Confidence Interval|Median
174828|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates of Overall Survival Time for Participants With Rai Stage I-II|Overall survival was defined as the time in days from the date of randomization to the date of death due to any cause plus 1 day for all participants. Results are stated in months and include participants with Rai Stage I or II.|Up to 6 years|Full analysis set of participants with Rai Stage I or II||months||95% Confidence Interval|Median
174829|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage III-IV|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage III or IV.|Up to 6 years|Full analysis set of participants with Rai stage III or IV||months||95% Confidence Interval|Median
174830|NCT00086580|Other Pre-specified|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) for Participants With Rai Stage I-II|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months and include participants with Rai stage I or II.|Up to 6 years|Full analysis set of participants with Rai stage I or II||months||95% Confidence Interval|Median
174831|NCT00086580|Secondary|Total Volume of Distribution (Vss) of Fludarabine|The total volume of distribution (Vss) is the apparent volume in which fludarabine is distributed immediately after it has been injected intravenously and equilibrated between plasma and the surrounding tissues. Total volume of distribution (Vss) of fludarabine is derived from plasma concentration versus time data.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population||liters||Standard Deviation|Mean
174832|NCT00086580|Secondary|Mean Systemic Clearance (CL) of Fludarabine|Clearance of drug from plasma is affected by the absorption, distribution, metabolism and elimination of the drug. Mean systemic clearance of fludarabine is derived from plasma concentration versus time data.|month 4 (cycle 4): first day of dosing (pre-dose, 0.5 hr end of infusion), second day of dosing (pre-dose, 0.5 hr end of infusion), third day of dosing (pre-dose, 0.25 hr, 0.5 hr end of infusion, 1,2,3,4,6,24,48,72 hr after start of fludarabine infusion)|Pharmacokinetic population||liters/hour||Standard Deviation|Mean
174833|NCT00086580|Secondary|Summary of Participants With Adverse Experiences (AEs)|Number of participants with adverse events (AEs). AEs were graded by the investigator using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and were assessed for relatedness to study treatment (4 point scale from 'not related' to 'definitely related'). Categories reported include participant counts for treatment-emergent AEs, AEs for infections, serious AEs, AEs causing discontinuation of study drug(s), and deaths. Related AEs for the combination arm can be related to either fludarabine or alemtuzumab.|Up to 6 years|Safety population||participants|||Number
174834|NCT00086580|Secondary|Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at End of Treatment|"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom."|up to month 6 (end of treatment)|Full analysis set. Participants who provided valid answers on questionnaires are included.||units on a scale||Standard Deviation|Mean
174835|NCT00086580|Secondary|Mean EuroQol Visual Analogue Scale (EQ-VAS) Scores to Measure Quality of Life at Baseline|"The EuroQol Visual Analogue Scale (EQ-VAS) was also used to capture the self-rating of current health status using a visual thermometer with the end points of 100 (best imaginable health state) at the top and zero (worst imaginable health state) at the bottom."|Day 0 (baseline)|Full analysis set. Participants who provided valid answers on questionnaires are included.||units on a scale||Standard Deviation|Mean
174836|NCT00086580|Secondary|Mean EQ-5D™ Index Scores to Measure Quality of Life at End of Treatment|EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59).|up to month 6 (end of treatment)|Full analysis dataset. Participants who provided valid answers on questionnaires are included.||units on a scale||Standard Deviation|Mean
174837|NCT00086580|Secondary|Mean EQ-5D™ Index Scores to Measure Quality of Life at Baseline|EQ-5D™ is a trademark of the EuroQol Group. EQ-5D™ is a standardized instrument for use as a measure of health outcome. The questionnaire asks about health status along 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression, which are rated at three possible levels (no problems, some problems, extreme problems). The score ranges from best (+1) to worst (-0.59).|Day 0 (baseline)|Full analysis dataset. Participants who provided valid answers on questionnaires are included.||units on a scale||Standard Deviation|Mean
174838|NCT00086580|Secondary|Kaplan-Meier Estimates for Time to Alternative Therapy|Time to alternative therapy was defined as the number of days from the date of randomization to the date of first alternative therapy for chronic lymphocytic leukemia (CLL) or death resulting from any cause. Participants who had not received alternative therapy as of the data cutoff date were censored at the last follow-up visit assessment date plus 1 day. Results are stated in months.|Up to 6 years|Full analysis set||months||95% Confidence Interval|Median
174839|NCT00086580|Secondary|Kaplan-Meier Estimates for Duration of Response Assessed by the Independent Response Review Panel (IRRP)|Duration of response was analyzed for participants who achieved a complete response (CR) or partial response (PR) and was defined as the number of days from the first date of documented response to the date of progressive disease as determined by IRRP or death due to any cause. Results are stated in months.|Up to 6 years|Full analysis set of participants who achieved a complete response or a partial response as determined by the IRRP.||months||95% Confidence Interval|Median
174842|NCT00086580|Secondary|Participant Best Response to Treatment Assessed by the Independent Response Review Panel (IRRP)|Participants were evaluated by the IRRP according to National Cancer Institute (NCI) 1996 response criteria. The best response observed during the study is summarized. Response categories include Complete Response (CR) with normal physical exam, marrow cells and blood values, Partial Response (PR) with a >= 50% decrease from baseline in lymphocytes, lymphadenopathy and liver or spleen exam, Stable Disease (SD) without significant progression from baseline, or Progressive Disease (PD) with increased size/number of nodes, size of liver or spleen, increase in lymphocytes, aggressive histology.|Up to 9 months|Full analysis set||participants|||Number
174843|NCT00086580|Primary|Kaplan-Meier Estimates for Progression-free Survival (PFS) Based on Independent Response Review Panel (IRRP) Assessment|Progression-free survival was defined as the number of days from the date of randomization to the date of first objective documentation of progressive disease (PD) as determined by the treatment-blinded IRRP, or death due to any cause. Results are expressed in months.|Up to 6 years|Full analysis set||months||95% Confidence Interval|Median
174844|NCT00086515|Secondary|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24|Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
174845|NCT00086515|Secondary|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|"Change from baseline at Week 24 is defined as FPG at~Week 24 minus FPG at Week 0."|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
174846|NCT00086515|Primary|Change From Baseline in Hemoglobin A1C (A1C) at Week 24|"A1C is measured as a percent. Thus, this change from~baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent."|Baseline and Week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
174847|NCT00086502|Secondary|Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24|Change from baseline at Week 24 is defined as Week 24 minus Week 0.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||mg/dL||95% Confidence Interval|Least Squares Mean
174848|NCT00086502|Primary|Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24|HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.|Baseline and week 24|The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last non-baseline observed measurement was carried forward to Week 24.||Percent||95% Confidence Interval|Least Squares Mean
174849|NCT00086450|Secondary|Rates of Individual MACCE Endpoints|Major adverse cardiovascular and cerebrovascular events|Measured at Day 30|||percentage of participants|||Number
174850|NCT00086450|Secondary|All-cause Mortality||Measured at Year 5|||percentage of participants|||Number
174851|NCT00086450|Secondary|Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization||Measured at Year 1|||percentage of participants|||Number
174852|NCT00086450|Primary|5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke|median 3.8 years of follow-up|Measured at Year 5|||percentage of participants|||Number
174853|NCT00086411|Secondary|Delineate Mediators Associated With Different Treatment Conditions (i.e., Medication Compliance, Participant Views of Self-help Written Materials and Counseling Type.||52 weeks||||||
174854|NCT00086411|Primary|Percent Treatment Sessions Attended|"Completion of Treatment and Smoking Cessation by Two Different Types of Medications and Counseling Types at 12, 26, and 52 Weeks Post-treatment Initiation. The counseling types were Medication Management (MM) and Mayo counseling models. MM counseling was a 4 session lower intensity counseling model and Mayo counseling was a 10 session higher intensity model.~A twofold definition of treatment completion included both medication and counseling session adherence. Treatment completion was defined as consistently taking the active medication as prescribed (80%) of the time during the medication period and attending at least 7 of the 10 required High C sessions or 3 of the 4 Low C sessions. Participants had to meet both requirements to be designated as full treatment completers.~Seven-day point prevalence abstinence was the primary measure of abstinence at follow-up Weeks 12, 24, and 52. Abstinence was confirmed by biochemical testing."|52 weeks|||Percentage of attended tx. sessions||Standard Error|Mean
174855|NCT00086385|Primary|Participants Abstinent From Cigarettes|Primary outcome variable was 7-day point prevalence cigarette abstinence verified biochemically at week 104|Two years|||participants|||Number
174856|NCT00086346|Primary|Patient and Graft Survival|Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses.|12 months|Intent to treat analysis population with stratification by antimetabolite therapy and hepatitis C status.||patients|||Number
174857|NCT00086346|Secondary|Mean Serum Creatinine|Observed mean values for serum creatinine.|12 months|On-therapy population; consisted of patients who were still receiving study medication at the defined endpoint.||µmol/L||Standard Deviation|Mean
174858|NCT00086346|Secondary|Number of Patients With a Biopsy Confirmed Acute Rejection|Overall event rate is determined as yes or no.|12 months|The analysis population is the intent to treat. Any patient whose clinical rejection data was incomplete was designated as an acute rejection in the analysis.||patients|||Number
174859|NCT00086346|Primary|Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)|GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is >90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.|Baseline and 12 months|The intent to treat population was analyzed and consisted of all patients randomly assigned to treatment. Patients were stratified by hepatitis C status and whether or not they were receiving antimetabolite therapy at time of randomization.||mL/min||Standard Error|Mean
174860|NCT00086307|Primary|Montgomery Asberg Depression Rating Scale (MADRS)|The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 item scale for assessing the severity of depression. Items are rated on a scale of 0 to 6, so the maximum score is 60 and the minimum is 0, where 60 is the most severe depression. Scores of 18 or greater are generally considered to indicate a moderate level of depression.|Weekly|All patients with at least one post-baseline measurement were included in the analysis.||Score on a scale||Standard Error|Least Squares Mean
174861|NCT00086281|Primary|The Primary Efficacy Variable Was the Mean Apnea-Hypopnea Index (AHI).|The AHI was defined as the incidence(events per hour) of apnea and hypopnea events associated with sleep, determined from the overnight polysomnogram (PSG). An apnea event is characterized by a cessation in airflow lasting >= 10 seconds, accompanied by oxygen desaturation of >3% or arousal. An Hyponea event is characterized by a transient reduction in breathing lasting >= 10 seconds, with clear decrease (>50%) from baseline in the amplitude of breathing or a decrease <50% in the amplitude of breathing accompanied by oxygen desaturation of >3% or arousal.|One night of PSG during one night of treatment each per arm.|||Apnea + Hypopnea episodes per hour||Standard Deviation|Mean
174862|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Mental Health|Short Form 36 Health Survey - Mental Health subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in SF-36 Mental Health score||Standard Error|Mean
174863|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Role-Emotional|Short Form 36 Health Survey - Emotional subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in SF-36 Role score||Standard Error|Mean
174864|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Vitality|Short Form 36 Health Survey - Vitality subscale ranges from 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in SF-36 vitality score||Standard Error|Mean
174865|NCT00086190|Secondary|Change in Short Form 36 Health Survey - Mental Component Summary|Short Form 36 Health Survey. Range 0-100. Higher score indicates a better perceived quality of life.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in SF-36 mental score||Standard Error|Mean
174866|NCT00086190|Secondary|Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Emotional Well-Being|Parkinson's Disease Questionnaire (PDQ-39) - Emotional Well-Being maximum score 24, minimum score of 0.Lower score indicates a better perceived health status.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in PDQ-39 Emotional score||Standard Error|Mean
174867|NCT00086190|Secondary|Change in Parkinson's Disease Questionnaire (PDQ) - 39 - Overall|Parkinson's Disease Questionnaire (PDQ-39) Total. Range 0-100. Lower score indicates a better perceived health status.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in PDQ-39 score||Standard Error|Mean
174868|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Bulbar|Unified Parkinson's Disease Rating Scale - Bulbar maximum score 24, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in UPDRS-Bulbar score||Standard Error|Mean
174869|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Tremor|Unified Parkinson's Disease Rating Scale - Tremor subscale ranges from 0-23. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in UPDRS-tremor score||Standard Error|Mean
174870|NCT00086190|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) - Motor|Unified Parkinson's Disease Rating Scale - Motor has a maximum score of 72, minimum score of 0. Higher score indicates more severe Parkinson's disease symptoms.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in UPDRS-motor score||Standard Error|Mean
174871|NCT00086190|Secondary|Change in Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index scores range from 0-21, with higher scores indicating severe sleep difficulties.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in PQSI score||Standard Error|Mean
174872|NCT00086190|Secondary|Change in Snaith Clinical Anxiety Scale (CAS)|Snaith Clinical Anxiety Scale. Range 0-21. Higher scores indicate increased anxiety. Score greater than 8 indicates clinical anxiety.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in CAS score||Standard Error|Mean
174873|NCT00086190|Secondary|Change in Unified Parkinson’s Disease Rating Scale (UPDRS)|Unified Parkinson's Disease Rating Scale. Higher score indicates more severe Parkinson's disease symptoms. Total maximum = 176. Mental maximum = 52, Activities of Daily Living maximum = 52, Motor maximum = 72. Minimum = 0.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in UPDRS score||Standard Error|Mean
174874|NCT00086190|Secondary|Change in Brief Psychiatric Rating Scale (BPRS)|Brief Psychiatric Rating Scale. Maximum score 126. Higher score indicates greater psychiatric difficulties.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in BPRS score||Standard Error|Mean
174875|NCT00086190|Secondary|Change in Geriatric Depression Rating Scale (GDS)|Geriatric Depression Scale ranges from 0-30. Higher score indicates more severe depression. 0-9 normal, 10-19 mild depression, 20-30 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in GDS score||Standard Error|Mean
174876|NCT00086190|Secondary|Change in Beck Depression Inventory II (BDI-II)|Beck Depression Inventory II ranges from 0-63. Higher score indicates more severe depression. 0-13 minimal depression, 14-19 mild depression, 20-28 moderate depression, 29-63 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in BDI-II score||Standard Error|Mean
174877|NCT00086190|Secondary|Change in Montgomery-Asberg Depression Rating Scale (MADRS)|Montgomery-Asberg Depression Rating Scale ranges from 0-60. Higher score indicates more severe depression. 0-6 normal, 7-19 mild depression, 20-34 moderate depression, greater than 34 severe depression.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in MADRS score||Standard Error|Mean
174878|NCT00086190|Primary|Change in Hamilton Depression Rating Scale (HAM-D) Scores|Change in Hamilton Rating Scale for Depression over 12 weeks. Hamilton Depression Rating Scale ranges from 0-50. Higher scores represent more significant depression. Mild depression ranges from 8-13, moderate depression from 14-18, severe 19-22 and very severe any score over 23.|from the beginning (0 weeks) to end (12 weeks) of the double-blind phase|115 subjects were randomized to receive either Paroxetine, Venlafaxine ER or placebo. All randomized participants were included in analysis, in accordance to intention-to-treat principle.||Change in HAM-D score||Standard Deviation|Mean
174879|NCT00086047|Secondary|Depressive Symptoms||9 weeks and 6 months||||||
174880|NCT00086047|Secondary|Pain Intensity||9 weeks and 6 months||||||
174881|NCT00086047|Primary|Change in FDI (Functional Disability Inventory) Scores at End of Study|Functional disability score is measured by the Functional Disability Inventory (FDI)which assesses ability to engage in usual physical, social and recreational activities. Scores range from 0=no disability to 60 = extreme disability and and are interpreted as No/Mild disability (0-12); Moderate Disability (13-29) and Severe Disability (30-60)|Baseline and 6 months (end of study)|Intent to treat analysis||units on a 0-60 scale||95% Confidence Interval|Mean
174882|NCT00085917|Secondary|Number of Participants With Adverse Events|"Adverse Events~- Anemia, Neutropenia and Psychiatric adverse events"|48 weeks|||participants|||Number
174883|NCT00085917|Secondary|Number of Participants With Normalization of Liver Enzymes|normalization of liver enzymes :Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) Alanine aminotransferase (ALT): Normal 6 - 41 U/L Aspartate aminotransferase (AST) : Normal 9 - 34 U/L|week 24, week 48, week 72|||participants|||Number
174884|NCT00085917|Primary|Number of Participants With Sustained Virologic Response (SVR)|SVR [ Sustained virological response] SVR was defined as HCV RNA levels below the limit of detection 24 weeks after the end of treatment.|72 weeks|||participants|||Number
174885|NCT00085839|Secondary|Best Tumor Response|Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.|While receiving study treatment (maximum 60 weeks)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.||participants|||Number
174886|NCT00085839|Secondary|Overall Survival|Median number of months from first study treatment until time of death|From first study treatment until time of death (maximum 26.8 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.||months||95% Confidence Interval|Median
174887|NCT00085839|Primary|Progression-free Survival|Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.|Until time of disease progression (maximum 5 months)|All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.||months||95% Confidence Interval|Median
174888|NCT00085709|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|For induction, daily for the first 10 days, then twice weekly until consolidation treatment. Weekly during consolidation treatment. Weekly if randomized to post-consolidation G.O.|Eligible patients who started therapy||Participants with a given type of AE|||Number
174889|NCT00085709|Primary|Complete Remission||After induction therapy was completed (1 or 2 months)|Eligible patients who did not withdraw consent||participants|||Number
174890|NCT00085709|Primary|2-year Disease-free Survival (DFS)|Measured from data of randomization to post-consolidation therapy until relapse from complete response or death from any cause, with observations censored at the date of last contact for patients last known to be alive without report of relapse.|After completing any treatment, every 6 months for 2 years, than annually for years 3-5|Eligible patients who completed induction and consolidation therapy||Percentage of population||95% Confidence Interval|Number
174891|NCT00085644|Secondary|Number of Subjects Achieving the Patient Acceptable Symptoms State Through Week 260 of Adalimumab Exposure|"Completed by subject at each visit. The Patient Acceptable Symptoms State (PASS) was a participant-reported outcome where participants were expected to respond (yes/no) to the following question:~Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?"|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174892|NCT00085644|Secondary|Number of Subjects With Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) MCID Response (MCID <= -1.8 Points) Through Week 260 of Adalimumab Exposure|ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement. Responders are participants with a minimal clinically important difference (MCID) <= -1.8 points. MCID was determined by a >= 1.8 score decrease during exposure to adalimumab.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174893|NCT00085644|Secondary|Mean Change in the Ankylosing Spondylitis Quality of Life Questionaire (ASQoL) in Subjects Through Week 260 of Adalimumab Exposure|"ASQoL determined participants' quality of life and is comprised of 18 questions (yes or no) to be completed by the participant. Each statement on the ASQoL is given a score of 1 or 0. All item scores were summed to give a total score or index. Total scores ranged from 0 (good quality of life) to 18 (poor quality of life) related to ability to cope, relationships, mood, sleep, motivation, activities of everyday living, independence, and social life. Decrease in ASQoL score represents improvement."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
174894|NCT00085644|Secondary|Mean Change in Health Utilities Index-3 (HUI-3) Through Week 260 of Adalimumab Exposure|The HUI-3 is a generic approach to the measurement of health status and assessment of health-related quality of life (HRQL). The HUI-3 classification is comprised of a total score and 8 attributes - Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain. The attributes are measures on a scale from the worst score of 0 to best score of 1. The total score scale ranges from dead (= 0) and perfect health (= 1). The total score can have a negative score that is interpreted as worse than dead and the lower limit is –0.36. An increase in the HUI-3 score represents improvement.|Baseline, Weeks 24, 52, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
174895|NCT00085644|Secondary|Number of Subjects With SF-36 Mental Component Summary (MCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning).~Responders were subjects whose change in MCS fulfilled the Minimal Clinically Important Difference (MCID). The MCID for MCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174896|NCT00085644|Secondary|Mean Change in the SF-36 Health Survey Index Mental Component Summary (MCS) Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
174939|NCT00085423|Secondary|Number of Participants With Lymphocyte Recovery as Measured by Blood Count|Lymphocyte recovery to a greater than 1000 cells/mcL was determined by differential peripheral blood cell counts on sequential days as noted in time frame.|on days 1-15, weekly for 2 weeks, and then every 2-3 months|each patient's differential blood counts were used to determine the time of recovery to the lower limit of normal lymphocytes in the peripheral blood.||participants|||Number
174897|NCT00085644|Secondary|Number of Subjects With SF-36 Physical Component Summary (PCS) of Minimal Clinically Important Difference (MCID) Response Through Week 260 of Adalimumab Exposure|"SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0(no functioning) to 100 (highest level of functioning).~Responders were subjects whose change in PCS score fulfilled the Minimal Clinically Important Difference (MCID). The MCID for PCS was determined by a >= 3.0 point increase during exposure to adalimumab."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174898|NCT00085644|Secondary|Mean Change in the SF-36 Health Survey Index Physical Component Summary (PCS) Through Week 260 of Adalimumab Exposure|SF-36 is a standardized survey evaluating 8 aspects of functional health and well being; physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The score for a section is an average of the individual question scores, which are scaled 0 (no functioning) to 100 (highest level of functioning). The SF-36 Health Survey Index was completed by participants. Components of the SF-36 included the PCS and MCS, respectively. An increase in SF-36 PCS or MCS indicated improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
174899|NCT00085644|Secondary|Mean Change in Nocturnal Pain in Subjects With Adalimumab Exposure Through Week 260|The subject was to assess his/her nocturnal pain intensity for the past week using a Nocturnal Pain Visual Analog Scale (Nocturnal Pain VAS). The range was 0 to 100 mm with no pain being indicated by 0 and worse possible pain by 100.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
174900|NCT00085644|Secondary|Mean Change in Physician's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|The physician will globally assess the subject's current disease state using a 100-mm VAS scale with 0 being very good and 100 being very bad.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
174901|NCT00085644|Secondary|Mean Change From Baseline in the Tender Joint Count for 46 Joints (TJC 46) in Subjects With Adalimumab Exposure Through Week 260|"Assessment of 46 joints for TJC was done by physical examination. Joint tenderness was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Hip, Knee, Ankle, and Metatarsophalangeal (1-5)."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
174902|NCT00085644|Secondary|Mean Change in Swollen Joint Count for 44 Joints (44 SJC) in Subjects With Adalimumab Exposure Through Week 260|"Change from Baseline in the swollen joint index. An assessment of 44 joints for SJC done by physical examination. Joint swelling was classified as present (1), absent (0) or injected/replaced (9). The joints assessed were: Sternoclavicular, Acromioclavicular, Shoulder, Elbow, Wrist, Metacarpophalangeal (1-5), Thumb interphalangeal, Proximal interphalangeal (2-5, Knee, Ankle, and Metatarsophalangeal (1-5)."|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 232, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
174903|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Global Index (BAS-G) in Subjects With Adalimumab Exposure Through Week 260|BAS-G was measured by two VAS scores (0 to 100 mm) to reflect the effect of Ankylosing Spondylitis on subject's well-being over the past week and over the last 6 months, respectively. The average of these two scores was reported.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
174904|NCT00085644|Secondary|Mean Change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) in Subjects With Adalimumab Exposure Through Week 260|MASES is measured by scoring of entheses of 0 (no tenderness) to 3 (severe tenderness) at 13 sites on the body. The score was derived as the sum of the 13 scores divided by 3 and the total range is 0 to 13 (minimum to maximum number and severity of enthesitis).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
174905|NCT00085644|Secondary|Mean Change in Chest Expansion (CE) in Subjects With Adalimumab Exposure Through Week 260 [|"The patient is in a sitting position on the examination table with the hands on the hips. A pen mark is made at the xiphisternum and a tape measure placed around the circumference of the patient's chest at this level. The patient is asked to take a deep breath and to exhale as completely as possible while looking directly ahead. The measurement (in cm) is noted. The patient is asked to inhale as deeply as possible and the measurement (in cm) is noted. The difference in the 2 measurement points (in cm) constitutes the value for CE.~An increase in chest expansion represents improvement"|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
174906|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Metrology Index (BASMI) in Subjects With Adalimumab Exposure Through Week 260|BASMI measures the range of motion based on five clinical measurements: 1) cervical rotation, 2) tragus to wall distance, 3) lumbar side flexion, 4) lumbar flexion (modified Schober's) and 5) intermalleolar distance. BASMI 0 = indicates mild disease involvement, 1 = moderate disease, and 2 = severe disease involvement. The results for cervical rotation and lumbar side flexion are the means of the left and right measurements. Scoring range 0-10. The higher the BASMI score, the more severe was the subject's limitation of movement due to their AS.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||score on a scale||Standard Deviation|Mean
174907|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured by ASAS Partial Remission Response in Subjects With Adalimumab Exposure Through Week 260|ASAS partial remission was calculated as follows: A value below 20 on a 0 - 100 point scale in each of the four domains of the ASAS (Patient's Global Assessment of Disease Activity, Pain, Function, and Inflammation). Partial remission is also regarded as a low disease activity state.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174908|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis Ankylosing Spondylitis (ASAS) 5/6 in Subjects With Adalimumab Exposure Through Week 260|"The change in ASAS 5/6 was evaluated for the effect of adalimumab on structural damage.~ASAS 5/6 criteria is the 20% improvement in 5 out of 6 domains (physical function [BASFI], Total Back Pain, Patient's Global Assessment of Disease Activity, Inflammation [mean of Questions 5 and 6 of the BASDAI], spinal mobility [BASMI], and acute phase reactants [CRP])."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174909|NCT00085644|Secondary|Number of Subjects With a Disease Controlling Clinical Response From Adalimumab as Measured in Assessments of Ankylosing Spondylitis (ASAS) 40 - Through Week 260 of Adalimumab Exposure|ASAS 40 responders - improvement of >=40% and absolute improvement of >=20 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]); Total Back Pain VAS (0 [no pain] to 100 [severe]); BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of any deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174910|NCT00085644|Secondary|Mean Change in C-Reactive Protein (CRP) (mg/dL) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the mean changes in CRP in subjects with adalimumab exposure from Baseline through 5 years. The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation via the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation. A decrease in CRP indicates improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mg/dL||Standard Deviation|Mean
174911|NCT00085644|Secondary|Mean Change in BASDAI in Subjects With Adalimumab Exposure Through Week 260|The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (severe). A decrease in BASDAI represents improvement. BASDAI Scoring: 1) Measure each item of the BASDAI in centimeters (out of a total of 10) 2) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
175445|NCT00076999|Secondary|Number Patients With HIV RNA <400 Copies/mL at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
174912|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 70 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 70% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174913|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. Improvement in BASDAI by 50% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174914|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 20 Through Week 260 of Adalimumab Exposure|"The BASDAI is a questionnaire with 6 questions that subject completes by marking answers on a 10-cm Visual Analog Scale (VAS) during the last week with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 (none) to 10 (very severe). Improvement in BASDAI by 20% was assessed. BASDAI Scoring:~Measure each item of the BASDAI in centimeters (out of a total of 10) BASDAI Score = 0.2 (Item 1 + Item 2 + Item 3 + Item 4 + Item 5/2 + Item 6/2)."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174915|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Inflammation (Individual Component of ASAS 20) (Mean of BASDAI Questions 5 and 6) Through Week 260 of Adalimumab Exposure|"The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 [none] to 10 [very severe]) and duration of morning stiffness (0 [0 hours] to 10 [2 or more hours]). A decrease in inflammation represents improvement.~A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline in inflammation (mean of the BASDAI questions 5 and 6 on scale of 0 [none] to 10 [very severe]."|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174916|NCT00085644|Secondary|Mean Change in Inflammation (Mean of BASDAI Questions 5 and 6) in Subjects With Adalimumab Exposure Through Week 260|The inflammation score is the mean of the two morning stiffness-related BASDAI visual analog scale (VAS) scores (items 5 and 6 of the BASDAI): overall level of morning stiffness (0 [none] to 10 [very severe]) and duration of morning stiffness (0 [0 hours] to 10 [2 or more hours]). A decrease in inflammation represents improvement.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||cm||Standard Deviation|Mean
174917|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Total Back Pain (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|Participants assessed disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain). A responder is a participant who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174918|NCT00085644|Secondary|Mean Change in Total Back Pain Visual Analog Scale (VAS) in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of 40 mg every other week (eow) adalimumab on Total Back Pain VAS. The subject was to assess his/her disease activity in the past week using a total spine VAS on a scale 0 (no pain) to 100 (severe pain).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
175446|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
174919|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in BASFI (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|BASFI consisted of 10 Visual Analog Scale (VAS) questions with a response ranging from 0 (easy) to 100 (impossible). The BASFI score was derived based on the average of questions 1 through 10. A responder is a subject who demonstrates an absolute improvement of at least 10 units and a percentage improvement of at least 20% from Baseline.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174920|NCT00085644|Secondary|Mean Change in the Bath Ankylosing Spondylitis Functional Index (BASFI) in Subjects With Adalimumab Exposure Through Week 260|BASFI consist of a set of 10 questions designed to determine the degree of functional limitation in subjects with AS. The BASFI score was derived based on the average of questions 1 through 10. The first 8 questions considered activities related to functional anatomy and the final 2 questions assessed the subject's ability to cope with everyday life over the last week. A 100-mm visual analog scale (VAS) was used to answer the questions and the mean of the ten scales gave the BASFI score a value between 0 (easy) and 100 (impossible).|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
174921|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Patient's Global Assessment of Disease Activity (an Individual Component of ASAS 20) Through Week 260 of Adalimumab Exposure|The patient assesses his/her disease activity for the past week using a Patient Global Assessment of Disease on visual analog scale (VAS) with 0 being none and 100 being severe.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174922|NCT00085644|Secondary|Mean Change in Patient's Global Assessment of Disease Activity in Subjects With Adalimumab Exposure Through Week 260|Evaluation of the effect of adalimumab 40 mg every other week (eow) on patient's global assessment of disease activity. The patient was to assess his/her disease activity in the past week using a visual analog scale (VAS) on a scale of 0 to 100 mm with no activity being indicated by 0 and severe activity by 100.|Baseline, Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||mm||Standard Deviation|Mean
174923|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 70 - Through Week 260 of Adalimumab Exposure|ASAS 70 responders - improvement of >=70% and absolute improvement of >=30 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]), Total Back Pain VAS; (0 [no pain] - 100 [severe]), BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of deterioration in the potential remaining domain, defined as defined as a worsening of >= 20% and a net worsening of >= 10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174924|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 50 - Through Week 260 of Adalimumab Exposure|ASAS 50 responders - improvement of >=50% and absolute improvement of >=20 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains: Patient's Global Assessment of disease activity VAS (0 [none] to 100 [severe]); Total Back Pain VAS (0 [no pain] to 100 [severe]); BASFI VAS (0 [easy] to 100[impossible]); and Inflammation VAS (1 [none] to 10 [very severe]); and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174925|NCT00085644|Secondary|Number of Subjects With a Reduction of Signs and Symptoms as Measured in Assessments of Ankylosing Spondylitis (ASAS) 20 - Through Week 260 of Adalimumab Exposure|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0[none]-100 [severe]), Total Back Pain VAS; (0 [no pain]-100 [severe]), BASFI VAS (0 [easy ]-100[impossible]); and Inflammation VAS (0 [none] to 10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Weeks 12, 24, 52, 76, 104, 128, 156, 180, 208, 220, 232, 244, and 260|Any Adalimumab Set - includes all participants who received at least 1 dose of adalimumab during the study, in either the double-blind or the open-label phase. 204 participants were randomized to 40 mg adalimumab every other week (eow) and 107 to placebo. The Any Adalimumab Set is analyzed by duration of exposure (weeks) to adalimumab.||participants|||Number
174940|NCT00085423|Primary|Number of partiCIPANTS WITH OBJECTIVE RESPONSE AS MEASURED BY RECIST|Objective response as measured by radiological and physical examination using RECIST criteria.|Response at 12 weeks|Response was determined by physical examination and radiologic testing. Percent of the total number of patients treated was calculated.||participants|||Number
174926|NCT00085644|Primary|Mean Change in the Modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) Compared Against a Historical Control Group (Outcomes in Ankylosing Spondylitis International Study [OASIS]) Using the ANCOVA Model Adjusting for Baseline mSASSS Score|Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 [no change] to 72 [progression]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.|Week 104|The OASIS cohort is a historical control group of Dutch, French, and Belgian patients with AS who have been followed up since 1996. These patients participated in a follow-up study on the natural course of AS with conventional (non-biologic) treatment.||score on a scale||Standard Error|Mean
174927|NCT00085644|Primary|Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20).|ASAS 20 responders - improvement of >=20% and absolute improvement of >=10 units from Baseline in a visual analog scale (VAS) for >=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 [none]-100 [severe]), Total Back Pain VAS (0 [no pain]-100 [severe]), BASFI VAS (0 [easy]-100[impossible]); and Inflammation VAS (0 [none]-10 [very severe]) and absence of deterioration in the potential remaining domain, defined as a worsening of >=20% and a net worsening of >=10 units. Applied to each scale and not to an overall global scale.|Week 12|||Participants (responders, nonresponders)|||Number
174928|NCT00085631|Primary|Five-Year Overall Survival|Five-year overall survival (OS) time was time from date of randomization until death from any cause. The 5-year OS rate is a percentage, representing the fraction of randomized patients who, after 5 years, are still alive.|5 Years||||||
174929|NCT00085631|Primary|Five-Year Local Recurrence-Free Survival|Five-year local recurrence-free survival (LRFS) time was defined as the time from randomization until local progressive disease or death from any cause. Local recurrence was defined as evidence of disease progression on physical exam or radiologic study, confirmed histologically by tissue biopsy. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year LRFS rate is a percentage representing the fraction of randomized patients who, after 5 years, do not have local progression or are alive.|5 years||||||
174930|NCT00085631|Primary|Five-year Failure-free Survival|Five-year failure free survival (FFS) time was defined as the time from randomization until relapse/disease progression (local and/or distant) or death from any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year FFS rate is a percentage representing the fraction of randomized patients who, after 5 years, are disease free or alive.|5 Years||||||
174931|NCT00085631|Primary|Primary Tumor Response Rate at 4-6 Weeks Post Treatment|Primary tumor response rate is the proportion of subjects achieving a best response of complete (CR) or partial (PR) responses, according to the RECIST criteria for change in sum of longest diameters.|3 months from start of therapy||||||
174932|NCT00085566|Primary|Overall Objective Response|Response will be evaluated in this study using the new international criteria Response Evaluation Criteria in Solid Tumors (RECIST)|2 years|||participants|||Number
174933|NCT00085540|Secondary|Response Rate Associated With Depsipeptide Therapy (Phase II)|"RECIST Complete Response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients must be on no steroids.~Partial Response (PR): Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions.~Stable/No Response: Does not qualify for CR, PR, or progression. The designation of Stable/No Response requires a minimum of 8 weeks duration.~Progression: 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear clinical worsening or failure to return for evaluation due to death or deteriorating condition"|Up to 2 years|GBM patients - no responses||participants|||Number
174934|NCT00085540|Primary|6 Months Progression-free Survival (Phase II)|evaluated patients with glioblastoma (GBM (35 patients)|At 6 months|evaluation of patients with GBM histology||percentage of participants|||Number
174935|NCT00085540|Primary|Number of Participants With Dose-limiting Toxicities Due to Romidepsin Graded According to the NCI Common Toxicity Criteria (CTCAE Version 3.0) (Phase I)|"dose limiting toxicity defined as: ANC </=1000 or Platelets <100K; SGOT >/= 3X ULN and T. Bili >/= 1.5 ULN~grade 3 Nausea, vomiting, fatigue and asymptomatic hypocalcemia (treatment may continue after discuss with PI)"|First 4 weeks of treatment|||participants|||Number
174936|NCT00085436|Secondary|Immunity as Measured by T-cell and Antibody Responses to the Tumor|All patients receiving at least one week of treatment and have at least two time points available for assessment of immune parameters will be include in the evaluation of immune status.|monthly for 5 months||||||
174937|NCT00085436|Primary|Clinical Response as Measured by RECIST Monthly and Then Every 2-3 Months|A total of 18 evaluable patients will be accrued in the first stage. If 4 or fewer responses are observed in the first stage, the trial will be stopped early, otherwise an additional 15 evaluable patients will be accrued for a total of 33 evaluable patients. If 11 or more responses are observed among the 33 patients, the experimental regimen will be considered for further study, otherwise it will be rejected. The trial will not proceed to the second stage unless at least 5 responses are observed in the first stage.|If 4 or fewer responses are observed in the first stage, the trial will be stopped|Clinical response as measured by RECIST monthly and then every 2-3 months||participants|Participants||Number
174938|NCT00085423|Secondary|Time to Progression as Measured by RECIST|Clinical outcome used the National Cancer Institute’s Response Evaluation Criteria in Solid Tumors (RECIST)1.0.|From date of randomization until the first date of documented progression or date of death from any cause, which ever came first, assessed up till 100 months|||years||95% Confidence Interval|Mean
174941|NCT00085293|Secondary|Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0|Summary of Adverse Events (AEs) by Maximum Grade where Grade 1 AEs >20%, Grade 2 AEs >10%, all Grade 3, Grade 4 and Grade 5 reported.|Up to 6 months|||percentage of participants|||Number
174943|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of CR/PR/SD of Any Radiographic Disease|Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|6 months||||||
174944|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) of Any Radiographic Disease|Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|3 months||||||
174945|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level||6 months||||||
174946|NCT00085293|Secondary|Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level||3 months||||||
174947|NCT00085293|Primary|Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration|"Number of participants with restoration of radioiodine responsiveness as determined by visible uptake on radioiodine scan in radiographically detectable metastatic foci of papillary or follicular thyroid carcinoma. Response to Decitabine defined as demonstration of radioiodine uptake determined by centralized blinded review of diagnostic scan. All who demonstrated radioiodine uptake in metastatic foci following decitabine therapy would then undergo thyroid hormone withdrawal and a second course of decitabine in preparation for therapeutic administration of radioiodine.~Diagnostic radioiodine scans following decitabine therapy (week 3) with a radioiodine scan following thyrotropin alfa stimulation, 0.9 mg intramuscular (IM) injection 24 and 48 hours before administration of the 131I for imaging. Whole body scans (WBS) performed using a gamma camera."|Week 3 following 2 weeks of Decitabine therapy|Per protocol, 1 participant interpreted by local treating investigator as responsive (increased radioiodine uptake on diagnostic scan after therapy), entered second decitabine treatment receiving radioiodine therapeutic dose. Subsequent central review of both scans for formal protocol response interpreted scans as negative for radioiodine uptake.||participants|||Number
174948|NCT00085254|Primary|Overall Survival (Phase II)|The overall survival is calculated from time of histological diagnosis to death occurance - median based on all 112 patients, all dose levels|up to 36 months|||months||95% Confidence Interval|Median
174949|NCT00085254|Secondary|Frequency of Hematologic and Nonhematologic Adverse Events|The proportion of patients with grade 3 and grade 4 hematologic and non hematologic adverse events per CTCAE 4.0|Up to 1 year|||Number of grade 3 or 4 events|||Number
174950|NCT00085254|Secondary|Overall Survival Based on Dose Level - Phase 2|survival calculated from date of initial histologic diagnosis and occurence of death. Pts at 500mg dose compared against Pts treated at 2000mg dose. Calculated using median|Up to 3 years|Phase 2 subjects only - does not include the 18 subjects from the safety run-in portion of study||months||95% Confidence Interval|Median
174951|NCT00085254|Primary|Maximum Tolerated or Tolerable Dose (MTD) - 3 Pre-defined Doses|"pts will be evaluated from first dose through end of initiation cycle. (6 weeks of RT+TMZ +EMD and 4 weeks of EMD alone) to review any dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (safety run-in)~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~cohorts at these 3 defined doses: 500mg, 1000mg and 2000mg MTD defined as: dose producing DLT in 2 out of 6 patients or dose level below the dose which produced DLT in >/= 2 out of 3 patients, or in >/= 3 out of 6 patients If no MTD (maximum tolerable dose) was defined through 3 steps of dose escalation, phase 2 will proceed with a randomized treatment allocation of the two pre-specified dosage arms: low dose; 500mg and high dose; 2000mg"|10 weeks|at least 3 pts per cohort will be used to review MTD rate for dose escalation in stepwise fashion of 3 defined doses: 500, 1000 and 2000mg. We will enroll 6 pts to ensure that 3 pts are evaluable due to high drop out rate.||mg|||Number
174952|NCT00085254|Primary|Dose Limiting Toxicities of EMD + RT and TMZ|"pts will be evaluated from first dose through end of initiation cycle. (6 weeks of RT+TMZ +EMD and 4 weeks of EMD alone) to review dose limiting toxicity (DLT) using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"|10 weeks|at least 3 pts per cohort will be used to review DLT rate for dose escalation in stepwise fashion. we will enroll 6 pts to ensure that 3 pts are evaluable due to high drop out rate.||participants|||Number
174953|NCT00085202|Primary|Frequency of Mutations Associated With SHH and WNT Tumors|"To estimate the frequency of mutations associated with SHH and WNT tumors via targeted sequencing.~This outcome was initially expected to be completed by September 2014. Technologic advancements have improved sequencing on formalin fixed paraffin embedded material using smaller quantities of nucleic acids. However, given that this technology is new, we had to thoroughly evaluate it on samples with abundant material first so as not to use up precious patient samples that are available in small quantities. The project has been delayed since extra time and care has gone into evaluating this technology to ensure that the data yield is accurate. We are now proceeding with a methodology that meets our quality controls."|within 3.5 years following completion of accrual||||||
174954|NCT00085202|Secondary|Mean RT Dose to Specified Target Tissue Volume by Rate and Pattern of Failure, e.g. Local Failure, Distant Failure, Etc.|To correlate radiation dosimetry of target and normal tissues with rate and patterns of failure and longitudinal measures of audiometric, endocrine and cognitive effects.|Once all patients have been followed for 2 years||||||
174955|NCT00085202|Secondary|Number of Average Risk Patients Whose Treatment Failure Included the Posterior Fossa|To monitor for treatment failure in the posterior fossa of patients whose tumor bed receives a reduced volume of radiation.|Annually for 6 years post irradiation||||||
174956|NCT00085202|Secondary|Reading Decoding Composite Scores in the Intervention and Standard of Care Groups|To compare the effects of a computer-based training system specifically targeting language, reading, and learning skills (Fast ForWord, Scientific Learning Corporation) with the current standard of care on reading decoding skills as measured by individual academic testing.|Measurements will be made at time of randomization, at 3 months from initiation of treatment, and yearly thereafter for 5 years||||||
174957|NCT00085202|Primary|Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.|122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.|2 years after tumor cell analysis in 122 participants|Analysis was completed for the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.||percentage of participants||Standard Error|Mean
174958|NCT00085202|Primary|Progression-Free Survival (PFS) in ERBB2-Negative Tumors Compared to ERBB2-Positive Tumors|The relationship between ERBB2 protein expression in tumors and progression-free survival was assessed in 122 participants with a diagnosis of medulloblastoma and with ERBB2 protein assessments. If the ERBB2 value was greater than zero, the ERBB2 was defined as positive for the participant. If the ERBB2 value was zero, the ERBB2 was defined as negative. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.|2 years after tumor cell analysis in 122 participants|Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.||probability of PFS at 2 years||Standard Error|Mean
174959|NCT00085098|Secondary|Quality of Life (QOL) and Neurocognitive Assessment (NP)|The primary endpoints for QOL and NP assessments will be the global scale value from each of these instruments at the two-year time point. Analyses of subscales (if they exist) and of assessments at other times will be of secondary interest. It is assumed that scale values are standardized to a reference normal population. Comparisons of each treatment group with the standard population mean, using a two-sided test with Type I error 0.025 (an adjustment for multiple comparison) will be able to detect differences from the standard mean that are 20% smaller.|Up to 2 years||||||
174960|NCT00085098|Secondary|Toxicity and Safety as Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0|The analysis of toxicity will focus on estimating the rates of key acute and subacute toxicity occurring during the first induction chemotherapy. Estimates will be obtained using life-table methods with an event defined as the first occurrence of a key acute or sub-acute toxicity. Patients who have progression or recurrence of disease will be censored in these analyses. The precision of the estimates of toxicity rate can be approximated by an analysis of binomial proportions.|From the beginning of treatment, assessed up to 5 years||||||
174961|NCT00085098|Secondary|Response||Up to 5 years||||||
174962|NCT00085098|Primary|Event-free Survival|"Data will be summarized as number of patients in the following categories at the time of data cutoff for analyses of 3-year EFS: 1)Experienced a qualifying event (QE) (see below);2)Event-free through 3 years of follow-up;3)Event-free until data cutoff (if less than 3 years of follow-up);4)Withdrew from study;5)Lost to follow-up.~QEs: 1)disease progression, defined as increase >= 40% in tumor volume or >= 25% in tumor area of target lesions;2)development of new lesions;3)occurrence of a second malignant neoplasm, defined as a malignancy with different histological type from trial-qualifying diagnosis;4)death from any cause.~Stat. analyses will be based on time from enrollment to the earliest of: 1)occurrence of any of the QEs;2)withdrawal from study or lost to follow-up;3)completion of three years of follow-up event-free;4)data cutoff for completion of the statistical analyses for the protocol’s primary objective.~NOTE: Reported data are through May 2009 (see Caveats section)."|Study enrollment until date of earliest qualifying event (QE), date last known to be QE-free if the patient is followed for less than three years and is QE-free at the time of analysis, or 3 years if the patient is QE-free at 3 years|By protocol design, all eligible patients were considered in the evaluation of primary study aim. Two (2) patients were considered ineligible. All other patients (10 enrolled to regimen A and 12 enrolled to regimen B) are included in the evaluation for the primary outcome measure.||participants|||Number
174963|NCT00084838|Other Pre-specified|Grade 3-4 Allergy/Immunology|All Grade 3-4 Allergy/Immunology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174964|NCT00084838|Other Pre-specified|Grade 3-4 Hemorrhage Events|All Grade 3-4 Hemorrhage events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174965|NCT00084838|Other Pre-specified|Grade 3-4 Dermatology Events|All Grade 3-4 Dermatology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174966|NCT00084838|Other Pre-specified|Grade 3-4 Renal/Genitourinary Events|All Grade 3-4 Renal/Genitourinary events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174967|NCT00084838|Other Pre-specified|Grade 3-4 Pulmonary Events|All Grade 3-4 Pulmonary events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174968|NCT00084838|Other Pre-specified|Grade 3-4 Cardiovascular Events|All Grade 3-4 Cardiovascular events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174972|NCT00084838|Other Pre-specified|Grade 3-4 Pain Events|All Grade 3-4 Pain events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174973|NCT00084838|Other Pre-specified|Grade 3-4 Neurology Events|All Grade 3-4 Neurology events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174974|NCT00084838|Other Pre-specified|Grade 3-4 Infection/Febrile Neutropenia Events|All Grade 3-4 Infection/Febrile Neutropenia events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174975|NCT00084838|Other Pre-specified|Grade 3-4 Metabolic/Laboratory Events|All Grade 3-4 Metabolic/Laboratory events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174976|NCT00084838|Other Pre-specified|Grade 3-4 Gastrointestinal Events|All Grade 3-4 Gastrointestinal events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174977|NCT00084838|Other Pre-specified|Grade 3-4 Blood/Bone Marrow Events|"All Grade 3-4 Blood/Bone Marrow events based on CTCAEv2 as reported on case report forms.~Arm Name"|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174978|NCT00084838|Other Pre-specified|Grade 3-4 Auditory/Hearing Events|All Grade 3-4 Auditory/Hearing events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174979|NCT00084838|Other Pre-specified|Grade 3/4 Events|All Grade 3-4 events based on CTCAEv2 as reported on case report forms.|Assessed during therapy up to 30 days post-therapy completion which is approximately 55 weeks for patients who completed therapy.|The analysis population excludes 1 patient who withdrew before treatment.||adverse events|||Number
174980|NCT00084838|Secondary|Pre-Radiation Therapy Chemotherapeutic Response|"Response pre-RT/post-CT was defined as follows with overall response defined as achieving PR or CR.~Complete Response (CR): Complete resolution of all initially demonstrable tumor on MRI or CT evaluation w/o appearance of any new areas of disease; negative CSF cytology. Partial Response (PR): >/= 50% decrease in the sum of the products of the maximum perpendicular diameters of the tumor (sum LD) relative to baseline w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Stable Disease (SD): <50% decrease in the sum LD w/o appearance of any new areas of disease; CSF cytology unchanged from that at diagnosis or clearing after being initially positive Progressive Disease (PD): >/= 25% increase in the sum LD relative to baseline, or the appearance of any new areas of disease or appearance of positive cytology after two consecutive negative samples."|Assessed at study entry and pre-RT/post-CT at week 7.|The pre-RT CT response evaluable population is defined as patients who completed chemotherapy per protocol.||proportion of evaluable patients||90% Confidence Interval|Number
174981|NCT00084838|Primary|2-yr Overall Survival|Overall survival is defined as the time from date of diagnosis to death or date of last follow-up. 2-year overall survival is the probability of patients remaining alive at 2-years from study entry estimated using Kaplan-Meier (KM) methods which censors patients at date of last follow-up. Precision of this conditional probability estimate was measured in terms of standard error. Median OS, the original primary endpoint, was not estimable based on the Kaplan-Meier method because of insufficient follow-up.|Patients are followed for survival up to 5 yrs post-therapy completion or death; As of this analysis, median follow-up among survivors was 31 months with the longest follow-up being 40 months.|The analysis dataset is comprised of all eligible and treated patients.||probability|||Number
174982|NCT00084747|Secondary|Overall Survival||up to 5 years from time of consent|||months||Full Range|Median
174983|NCT00084747|Primary|Progression-free Survival|Disease Progression: The day when bone marrow recurrence and/or new lytic bone marrow lesions on radiograph and/or progressive M-component paraprotein (~ 25% increase) were detected. Paraprotein progression will be confirmed labs on the consecutive month.|signed consent to progression or end of trial. Up to 5 years.|||months||Full Range|Median
174984|NCT00084682|Secondary|Overall Survival|All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates. One and two-year survival and median survival time (if attained) will be estimated and reported with 95% confidence limits. If the sample sizes are sufficient, subgroup analysis based on baseline factors will be performed using the log rank test to compare survival curves.|Up to 2 years||||||
174985|NCT00084682|Secondary|Time to Progression|All time to event endpoints will be evaluated using Kaplan Meier estimates and survival curves will be generated based on these estimates.|Up to 2 years||||||
174986|NCT00084682|Secondary|Duration of Response||Up to 2 years||||||
174987|NCT00084682|Primary|Disease Control (i.e., Achievement of Complete Response, Partial Response, or Stable Disease)|Tumor response was assessed every eight weeks by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria|Up to 2 years|||participation||95% Confidence Interval|Number
174988|NCT00084617|Secondary|Overall Survival|Length of time patients survived after treatment|at 40 months from study activation|All patients enrolled in study||months||95% Confidence Interval|Median
174989|NCT00084617|Secondary|Complete Response (CR) and Partial Response (PR) Duration|The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).|at 40 months from study activation|Patients that achieved either a CR or PR.||months||95% Confidence Interval|Median
174990|NCT00084617|Primary|Response Rates (RR) in Metastatic Gastric/GE Junction Tumors|Response is defined as the number of patients with a CR (Complete Response) or PR (Partial Response) per Response Evaluation Criteria in Solid Tumor (RECIST criteria). Possible evaluations include: CR: Disappearance of all target lesions. PR: At least a 30% decrease in the size of target lesions. Progressive Disease (PD): At least a 20% increase in the size of the target lesions or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage or increase of target lesions.|at 12 weeks (after 2 cycles of treatment)|Patients that completed at least 2 cycles of treatment||participants|||Number
174991|NCT00084487|Secondary|Overall Survival|Percentage of patients alive at 1 year|1 year|Intent to treat||percentage of participants||95% Confidence Interval|Number
174992|NCT00084487|Secondary|Progression Free Survival|Percentage of patients that are progression free at 6 months.|6 months|Intent to treat||percentage of participants||95% Confidence Interval|Number
174993|NCT00084487|Primary|Overall Survival|Median time of patient survival. Duration of survival will be analyzed using Kaplan-Meier curves.|Up to 4 years|Intent to treat||months||95% Confidence Interval|Median
174994|NCT00084487|Primary|Progression Free Survival|Median time of patients without Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Duration of remission will be analyzed using Kaplan-Meier curves.|Up to 4 years|Intent to treat||months||95% Confidence Interval|Median
174995|NCT00084487|Primary|Objective Response Rate Estimated as the Proportion of Responders|"Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.~An exact binomial 95% confidence interval will be calculated for this proportion."|Up to 4 years|Intent to treat||participants|||Number
174996|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.~From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.||Percentage points||Standard Deviation|Mean
174997|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.~From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.~From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.~The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.||WHO Units||Standard Deviation|Mean
174998|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Baseline Non-Normal Pairs|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies. Any pair for which the baseline WHO score was 1 (i.e. normal tissue) was excluded from the analysis.~From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years|The analysis was restricted to the 107 subjects (52 in the iloprost group, 55 in the placebo group) with at least 1 non-normal biopsy at baseline, thereby excluding the 18 subjects (8 in the iloprost group and 10 in the placebo group) who had only normal biopsy tissue at baseline.||WHO Units||Standard Deviation|Mean
174999|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies.~From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years|||Percentage points||Standard Deviation|Mean
175000|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies.~From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.~From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.~The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years|||WHO Units||Standard Deviation|Mean
175894|NCT00069823|Secondary|Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity|Pulmonary function measured by mean change in Prebronchodilator forced vital capacity from baseline to 24 weeks|Baseline to 24 Weeks|||liters||95% Confidence Interval|Mean
175001|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Matched Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are restricted to biopsies from anatomical sites that were biopsies during both the baseline and follow-up bronchoscopies, thus creating pairs of biopsies.~From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years|||WHO Units||Standard Deviation|Mean
175002|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6.~From these biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From these biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years|||Percentage points||Standard Deviation|Mean
175003|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL, RML, RB6, LUL, LUDB, and LB6.~From these biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.~From these biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.~The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years|||WHO Units||Standard Deviation|Mean
175004|NCT00084409|Secondary|Change in Average (Follow-up - Baseline) Using Reference Sites|"This outcome measure is created for each subject as follows:~The biopsies used in this analysis are those from the following 6 anatomical sites pre-specified in the protocol to be biopsied: RUL (Right upper lobe: the superior region of the right lung), RML (Right middle lobe: an anatomic portion of the right lung), RB6 (The carina in the right lower lobe at the entrance to the superior segment), LUL (Left upper lobe: the superior portion of the lung), LUDB (Left upper division bronchus: the carina between the lingular orifice and the left upper lobe), and LB6 (The carina in the left lower lobe at the entrance to the superior segment).~From these biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From these biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|9 Years|||WHO Units||Standard Deviation|Mean
175005|NCT00084409|Secondary|Change in Dysplasia Index (Follow-up - Baseline) Using All Biopsies|"This outcome measure is created for each subject as follows:~From all biopsies scored at the baseline bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated (this is the definition of Dysplasia Index (DI)).~From all biopsies scored at the follow-up bronchoscopy, the percentage with a WHO score greater than or equal to 4 is calculated.~The difference (follow-up DI - baseline DI) is used as the outcome measure for each subject."|9 Years|||Percentage points||Standard Deviation|Mean
175006|NCT00084409|Secondary|Change in Maximum (Follow-up - Baseline) Using All Biopsies|"This outcome measure is created for each subject as follows:~From all biopsies scored at the baseline bronchoscopy, the maximum WHO score is used.~From all biopsies scored at the follow-up bronchoscopy, the maximum WHO score is used.~The difference (follow-up maximum - baseline maximum) is used as the outcome measure for each subject."|9 Years|||WHO Units||Standard Deviation|Mean
175007|NCT00084409|Other Pre-specified|Define the Genes Whose Expression is Altered by Iloprost Treatment by Gene Expression Arrays and Quantitative PCR.||Nine Years||||||
175008|NCT00084409|Other Pre-specified|To Determine the Toxicity Profile of Iloprost in Patients at High Risk to Develop Lung Cancer.||Nine Years||||||
175009|NCT00084409|Other Pre-specified|To Determine Whether Iloprost Affects Prostaglandin Metabolism by Examining 4 Markers, PGIS, COX-2, PPAR and PPAR.|PGIS (Prostacyclin synthase: an enzyme in the eicosanoid pathway that catalyzes the conversion of prostaglandin H2 to prostaglandin I2 (prostacyclin). PPAR (Peroxisome proliferator-activated receptor: a group of nuclear receptor proteins that act as transcription factors regulating gene expression),|Nine years||||||
175010|NCT00084409|Other Pre-specified|To Determine if Iloprost Can Modulate K-67 Proliferation Index in Patients at High Risk to Develop Lung Cancer||nine years||||||
175011|NCT00084409|Secondary|To Determine Whether Iloprost Can Modulate a Panel of Biomarkers Including MCM-1 EGFR Mutations in Egfr Expression or Activity Can Result in Cancer), Her-2/Neu, RAR, p53 FHIT, Apoptotic Index, and Microvessel Density.|MCM (Minichromosome maintenance protein: forms DNA helicase), EGFR (Epidermal growth factor receptor: cell surface receptor for the epidermal growth factor family of proteins. Mutations in egfr expression or activity can result in cancer). RAR (Retinoic Acid Receptor Beta is a nuclear transcription regulator and a member of the thyroid-steroid hormone receptor superfamily).FHIT (Fragile histidine triad protein is an enzyme involved in purine metabolism and had been demonstrated to be a tumor suppressor).|Nine years||||||
175012|NCT00084409|Primary|Change in Average (Follow-up - Baseline) From All Biopsies|"This outcome measure is created for each subject as follows:~From all biopsies scored at the baseline bronchoscopy, the mean WHO score is calculated.~From all biopsies scored at the follow-up bronchoscopy, the mean WHO score is calculated.Histology on bronchial biopsies pre-treatment and post-treatment will be compared. All biopsies will be graded according to the WHO classification for bronchial epithelium for this outcome, and all the following outcomes.~WHO Classification Grade Normal 1.0 Reserve Cell Hyperplasia 2.0 Metaplasia 3.0 Mild Dysplasia 4.0 Moderate Dysplasia 5.0 Severe Dysplasia 6.0 Carcinoma in Situ 7.0 Carcinoma 8.0~The difference (follow-up mean - baseline mean) is used as the outcome measure for each subject."|Nine years|||WHO Units||Standard Deviation|Mean
175013|NCT00084383|Primary|Disease-free Survival|Disease-free Survival in Patients Treated With Adjuvant Chemoradiotherapy in Sequence With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines. DFS is defined as time from surgery until clinical evidence of disease (eg, CT scan) or death due to any cause.|Participants were followed for the duration of the study, an average of 2 years|||Months||95% Confidence Interval|Median
175201|NCT00081328|Secondary|Body Composition -- BMI|Body mass index (BMI) measured in kg per meters squared. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Cohort measured at 24 months and had not experienced treatment failure.||kg per meters squared||Standard Deviation|Mean
175014|NCT00084383|Secondary|Estimate the Association of Specific in Vivo Parameters of Immune Response With Clinical Responses in Patients Treated With Combination Chemoradiotherapy Together With the Irradiated Allogeneic GM-CSF Transfected Pancreatic Tumor Cell Lines.|The specific immune parameters include: post-vaccination delayed type hypersensitivity reactions to autologous tumor and the degree of local eosinophil, macrophage, and T cell infiltration at the vaccine site, and mesothelin-specific T cell responses.|Continuous||||||
175015|NCT00084383|Secondary|To Further Identify and Characterize Toxicities Associated With Intradermal Injections of the Vaccine That Were Initially Reported in the Phase 1 Trial.||4 years||||||
175016|NCT00084383|Primary|Overall Survival|Overall survival in patients treated with adjuvant chemoradiotherapy in sequence with the irradiated allogeneic GM-CSF transfected pancreatic tumor cell lines. Overall survival is defined as time from surgery until death, regardless of cause.|Participants were followed for the duration of the study, an average of 2 years|||Months||95% Confidence Interval|Median
175017|NCT00084318|Secondary|Correlation of EGFR (Total and Phosphorylated) pMAPK, pAKT, Stat-3, KI-67, COX-2, and Cyclin B1 Expression With Local-regional Control, and Overall and Disease-free Survival|Biomarker data has not yet been obtained and therefore this outcome measure cannot yet be reported.|From randomization to two years||||||
175018|NCT00084318|Secondary|Local-regional Control|Two-year rate is shown (cumulative incidence estimate). Local-regional failure is defined as the time from randomization to local-regional recurrence (event), death (competing risk), or last follow-up (censored).|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
175019|NCT00084318|Secondary|Frequency of Other Acute and Late Toxicity|Maximum grade toxicity that is definitely, probably, or possibly related to protocol treatment.|From start of treatment to last follow-up. Analysis occurs at the time of the primary endpoint analysis.|Eligible patients who started protocol treatment and did not withdraw consent||percentage of participants|||Number
175020|NCT00084318|Secondary|Frequency of Toxicity (Grade 5 and Acute Non-hematologic Grade 4)|Each regimen was monitored for excessive acute toxicity (defined as nonhematologic grade 4 toxicity within 90 days of the start of radiation or any grade 5 toxicity). The target rate was based on the observed rate from RTOG-9501/NCT00002670 of 15%. The unacceptable rate was >30%. [RTOG = Radiation Therapy Oncology Group]|From start of treatment to last follow-up. Analysis occurs at the time of the primary analysis.|Eligible patients who started protocol treatment and did not withdraw consent||percentage of participants||95% Confidence Interval|Number
175021|NCT00084318|Secondary|Treatment Tolerance|Tolerability was defined as having received 90% of the radiation dose, 95% of the cetuximab loading dose, and at least 4 weeks of cetuximab and cisplatin or docetaxel at doses 95% of the protocol prescription. The percentage of patients determined to be tolerant of treatment are shown.|From start of treatment to end of treatment (protocol treatment lasts seven weeks).|Eligible patients who started protocol treatment and did not withdraw consent||percentage of participants||95% Confidence Interval|Number
175022|NCT00084318|Secondary|Overall Survival|Two-year rates are shown (Kaplan-Meier estimates). Overall survival is defined as the time from randomization to death (event) or last follow-up (censored).|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent||percentage of participants||95% Confidence Interval|Number
175023|NCT00084318|Primary|Disease-free Survival|Two-year rates are shown (Kaplan-Meier estimates). Disease-free survival is defined as the time from randomization to local, regional, or distant progression, second primary, or death (event) or last follow-up (censored). Response criteria as follows: No evidence of disease (NED): All patients must have no measurable tumor following surgery; Local-Regional Relapse: Recurrent cancer in the tumor bed and/or neck not clearly attributable to a second primary neoplasm; biopsy confirmation is necessary; Distant Relapse: Clear evidence of distant metastases (lung, bone, brain, etc.); Biopsy is recommended where possible. A solitary lung mass/nodule is considered a second primary neoplasm unless proven otherwise.|From randomization to 2 years|Eligible patients who started protocol treatment and did not withdraw consent.||percentage of participants||95% Confidence Interval|Number
175024|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for ITT Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|ITT population included all participants who received at least one dose of study medication.||Days||Standard Error|Mean
175025|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for mITT Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA.||Days||Standard Error|Median
175026|NCT00084266|Secondary|Survival Status Estimated by Kaplan-Meier Analysis for PP Population|For each participant, time to death was estimated from baseline to date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose. The distribution of survival was estimated for the treatment groups using the Kaplan-Meier, product-limit method and compared between the treatment groups using the log rank statistic.|From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 days after last dose.|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Days||Standard Error|Mean
175027|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT for mITT Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOT (within 72 hours of last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
175028|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOT for PP Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
175029|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOS for mITT Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOS (7-30 days after last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
175030|NCT00084266|Secondary|Number of Participants With Clinical Signs and Symptoms at EOS for PP Population|Participant’s clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms (mild to severe) of nosocomial pneumonia included cough; production of purulent sputum or change in character of sputum;auscultatory findings on pulmonary examination of rales and/or pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony); and dyspnea, tachypnea, or hypoxemia with PaO2 <60 mmHg or worsening gas exchange or increased oxygen requirements; pleuritic chest pain; chills/rigors; and decreased breath sounds.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
175031|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOT (within 72 hours of last dose)|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
175032|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
175033|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOS (7-30 days after last dose)|mITT population included all ITT participants (who received at least 1 dose of drug) with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
175120|NCT00083122|Secondary|Overall Survival|Will be estimated using the method of Kaplan-Meier.|Time from registration to date of last follow-up or death due to any cause, assessed up to 3 years|All 40 participants in Group 1 were analyzed for this primary endpoint. However, due to the low accrual and early group 2 closure, Group 2 was not statistically evaluated for this endpoint.||months||95% Confidence Interval|Median
175034|NCT00084266|Secondary|Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population|Microbiological response assessed at participant level.Eradication:baseline isolate not present in repeat culture from original infection site;Presumed Eradication:clinical response of cure precluded availability of specimen for culture;Persistence:baseline isolate present in repeat culture;Presumed Persistence:culture data not available for participant with clinical response of failure;Superinfection:culture from primary infection site had new pathogen not identified as baseline isolate and clinical response was failure;Indeterminate:any participant who cannot be classified into any of above.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
175035|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population|Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.|EOT (within 72 hours of last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
175036|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population|Clinical response evaluated at EOT visit as Cure:resolution of clinical sign/symptoms of pneumonia when compared with baseline;Improvement: in 2 or more clinical sign/symptoms of pneumonia when compared with baseline,improvement/lack of progression of all chest X-ray abnormalities,Failure: persistence/ progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection;Unknown: extenuating circumstances precluding classification to 1 of above.|EOT (within 72 hours of last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure)and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
175037|NCT00084266|Secondary|Clinical Outcome in Participants With Baseline MRSA at EOS for mITT Population|Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.|EOS (7-30 days after last dose)|mITT population included all ITT participants who received at least 1 dose of drug with a diagnosis of nosocomial pneumonia caused by proven MRSA and had an observed outcome for that visit unless already declared a failure prior to that visit.||Participants|||Number
175038|NCT00084266|Primary|Clinical Outcome in Participants With Baseline Methicillin Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for PP Population|Clinical response was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation timepoint. Clinical response was evaluated at EOS Visit as Cure: resolution of clinical signs/symptoms of pneumonia when compared with baseline; Failure: persistence/progression of baseline signs/symptoms of pneumonia or baseline radiographic abnormalities after atleast 2 days of treatment; development of new pulmonary/extrapulmonary clinical findings consistent with active infection; Unknown:extenuating circumstances precluding classification to 1 of the above.|EOS (7-30 days after last dose)|PP population included all mITT participants who satisfied all critical inclusion/exclusion criteria,had adequate dosing of drug (defined as 5 full days for success or 2 full days of treatment for participants whose clinical outcome was considered failure) and had observed outcome for that visit unless already declared failure prior to that visit.||Participants|||Number
175039|NCT00084136|Secondary|Time to First Dose Modification or Grade 3 or 4 Adverse Event (NRTI Comparison)|Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study follow-up until study closure (May 31, 2010)|Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.||weeks||95% Confidence Interval|Number
175040|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)|Time to any of the following events occurring prior to week 96: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 96 using follow-up through study closure on May 31,2010|||weeks||95% Confidence Interval|Number
175041|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 using follow-up through study closure on May 31,2010|||weeks||95% Confidence Interval|Number
175447|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
175042|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 96 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 96: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 96 (using follow-up through to study closure on May 31,2010)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.||weeks||95% Confidence Interval|Number
175043|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(NRTI Comparison)|Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up through study closure on May 31,2010)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.||weeks||95% Confidence Interval|Number
175044|NCT00084136|Secondary|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (NRTI Comparison)|Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored.|At Weeks 24 and 48 (including follow-up through to study closure on May 31, 2010)|ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.||participants|||Number
175045|NCT00084136|Secondary|Change in CD4 Count From Screening to Weeks 24, 48, 96 (NRTI Comparison)|Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).|weeks 24, 48 and 96 (including all follow-up through to study closure on May 31, 2010)|ITT - ignoring both current treatment status and treatment history.||cells/mm^3||Inter-Quartile Range|Median
175046|NCT00084136|Secondary|Time to Immunologic Failure (NRTI Comparison)|Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.|At or after Week 48 (including all follow-up through study closure - May 31,2010)|||weeks||95% Confidence Interval|Number
175047|NCT00084136|Secondary|Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (NRTI Comparison)|Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).|Throughout follow-up until study closed (May 31,2010)|Participants not starting study treatment excluded.||weeks||95% Confidence Interval|Number
175048|NCT00084136|Secondary|Time to Loss of Virologic Response at Week 48 (Defined by FDA TLOVR Algorithm - Including All ARV Substitutions)(PI Comparison)|Time from randomization to any of the following events occurring prior to week 48: changed any ARV medication (including permanent discontinuation of all medications); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)|||weeks||95% Confidence Interval|Number
175049|NCT00084136|Secondary|Time to Loss of Virologic Response by Week 48 (Defined by FDA TLOVR Algorithm - Excluding Study Allowed ARV Substitutions)(PI Comparison)|Time from randomization to any of the following events occurring prior to week 48: discontinued ARV regimen (see time to discontinuation of initial ARV therapy above); discontinued study follow-up or died; absence of virologic suppression defined as 2 consecutive plasma HIV-1 RNA values < 400 copies/mL; two consecutive plasma HIV-1 RNA values > 400 copies/mL following virologic suppression.|Week 48 (using follow-up only until closing of ddI+FTV+ATV arm on May 22,2008)|Substitutions not triggering TLOVR event included the following: stavudine or tenofovir-DF for zidovudine; nevirapine for efavirenz; or didanosine for tenofovir-DF.||weeks||95% Confidence Interval|Number
175050|NCT00084136|Secondary|Plasma HIV-1 Viral Load Fewer Than 400 Copies/ml (PI Comparison)|Number of participants with plasma HIV-1 Viral load fewer than 400 copies/mL at study visit weeks 24 and 48. Closest observed result between 20 and up to 28 weeks (for week 24), and between 44 and up to 52 (for week 48) used if multiple results available. Missing values excluded, and both study treatment status and history ignored.|At Weeks 24 and 48 (including only follow-up until ddI+FTC+ARV arm closed - May 22, 2008)|ITT (ignoring current treatment status or past treatment history); closest value to week 24 (48) used if multiple values available; missing values ignored.||participants|||Number
175051|NCT00084136|Secondary|Time to First Dose Modification or Grade 3 or 4 Adverse Event (PI Comparison)|Time from treatment dispensation to the first occurring of the following: week of first ARV medication change; week of first grade 3 or higher sign/symptom or laboratory abnormality (total bilirubin was excluded) that was at least one grade higher than baseline. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.|Throughout study follow-up until ddI+FTC+ATV arm closed (May 22, 2008)|Participants never starting meds excluded. Censoring time is scheduled study week of last clinic visit.||weeks||95% Confidence Interval|Number
175052|NCT00084136|Secondary|Change in CD4 Count From Screening to Weeks 24, 48, 96 (PI Comparison)|Available pre-randomization CD4 cell counts were limited to the single CD4 cell count used for study eligibility (and therefore must have been fewer than 300 cells/mm3).|weeks 24, 48 and 96 (including follow-up until ddI+FTC+ARV arm closed - May 22, 2008)|ITT - ignoring both current treatment status and treatment history.||cells/mm^3||Inter-Quartile Range|Median
175053|NCT00084136|Secondary|Time to Immunologic Failure (PI Comparison)|Time from randomization to the first scheduled study visit (week 48 or later) with a CD4+ cell count fewer than 100 cells/mm3.|At or after Week 48 (including only follow-up until ddI+FTV+ATV arm closed - May 22,2008)|ITT (ignoring current study treatment status or history)||weeks||95% Confidence Interval|Number
175054|NCT00084136|Secondary|Time to Discontinuation of Initial Antiretroviral (ARV) Therapy (PI Comparison)|Time is measured from date of treatment initiation to earliest of the following: date of last participant contact (premature discontinuation of study follow-up); date all ARV medications were held (if all medications held for at least 8 weeks, for any reason); date that any ARV medication was changed (excluding the following single ARV substitutions: stavudine or tenofovir for zidovudine, nevirapine for efavirenz, or didanosine for tenofovir).|Throughout follow-up until ddI+FTC+ATV arm closed (May 22,2008)|Participants not starting study treatment excluded.||weeks||95% Confidence Interval|Number
175055|NCT00084136|Primary|Time to Treatment Failure (NRTI Comparison)|Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005) plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).|Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up through study closure (May 31, 2010).|ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.||weeks||95% Confidence Interval|Number
175056|NCT00084136|Primary|Time to Treatment Failure (PI Comparison)|Time from randomization to the earliest of: scheduled week of first plasma sample meeting virologic failure (two consecutive plasma HIV-1 RNA values 1,000 copies/mL or higher, regardless of whether ARV medications being taken at the time); scheduled week of first AIDS defining diagnosis (WHO Stage 4 (2005), plus microsporidiosis, cyclospora gastroenteritis and Chaga's disease), not attributed to Immune Reconstitution Inflammatory Syndrome (reviewed by chairs); date of death (due to any cause). Plasma drawn every 8 weeks (except confirmation samples could be drawn earlier).|Virologic failure starting 14 weeks following randomization; disease progression starting 12 weeks following randomization; and death occurring at any time following randomization. Follow-up until ddI+FTC+ATV arm closed (May 22, 2008).|ITT (study treatment status and history ignored); censoring time was latest study visit week where plasma HIV-1 RNA was measured.||weeks||95% Confidence Interval|Number
175057|NCT00084084|Secondary|Pharmacokinetics - Maximum Observed Serum Concentration (Cmax)|Cmax is the peak plasma concentration of a drug after administration.|341 weeks|||U/mL||Standard Deviation|Mean
175058|NCT00084084|Other Pre-specified|Heart Rate Variability - Change From Baseline at Week 185 in SDNN|Heart rate variability was assessed by 2-hour Holter monitoring. Standard deviation of all filtered RR intervals over the length of the analysis (SDNN) was measured.|Week 185|Number of participants present at Visit Week 185 included for analysis.||msec||Standard Deviation|Mean
175059|NCT00084084|Secondary|Pharmacokinetics - Area Under the Serum Concentration-Time Curve (AUC0-∞)|AUC0-∞ is a measure of the total exposure to a drug.|341 weeks|PK Population: All patients who received at least 1 dose of Replagal (RB or AF) and had at least 1 PK sample drawn.||min·U/mL||Standard Deviation|Mean
175060|NCT00084084|Primary|Patients Who Experienced At Least One Adverse Event (AE)||362 weeks|Safety Population: Patients in Cohort 1 who received at least one dose of Replagal RB in Phase 1.||participants|||Number
175061|NCT00083915|Secondary|Side Effects With DT PACE-Melphalan vs Side Effects With Melphalan Alone|Compare side effects with the new regimen of DT PACE-Melphalan, compared to melphalan alone|3 years depending on start date||||||
175062|NCT00083915|Primary|Transplant With DT PACE-Melphalan Regimen of Chemotherapy vs. Transplant With Melphalan Alone.|Compare a new regimen of chemotherapy called DT PACE-Melphalan (new experimental therapy) is better than transplant with Melphalan alone (standard therapy)|3 years depending on start date|only 2 participants in HD melphalan group completed the study and only 8 from the Mel-DT Pace group completed the study. No analysis done.||participant|||Number
175063|NCT00083889|Secondary|Ctrough Concentrations of SU011248 and Active Metabolite SU012662|Subject observed Ctrough (trough drug) concentrations of total drug (SU011248 and its active metabolite SU012662) per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples at observation.||ng/mL||Standard Deviation|Mean
175064|NCT00083889|Secondary|Ctrough Concentrations of Metabolite SU012662|Subject observed Ctrough (trough drug) concentrations of active metabolite SU012662 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples||ng/mL||Standard Deviation|Mean
175065|NCT00083889|Secondary|Ctrough Concentrations of SU011248|Subject observed Ctrough (trough drug) concentrations of SU011248 per cycle and study day determined by plasma trough samples collected from a subset of patients. Steady-state observed trough concentrations were dose corrected to the starting dose (reference dose) where appropriate. Concentrations below the limits of quantitation (BLQ) were set to 0. Ctrough = minimum (trough) plasma concentration (nanograms per milliliter [ng/mL]).|Day 28 of Cycle 1 to Cycle 4|As treated (AT) population: all patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received. Pharmacokinetic (PK) analyses were performed on the AT population who had at least one PK sample. n=number of subjects with evaluable trough samples.||ng/mL||Standard Deviation|Mean
176503|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 24|Percentage of participants with Viral Load < 400 copies/mL|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
175066|NCT00083889|Secondary|Incremental Cost Effectiveness Ratio (ICER)|Incremental cost effectiveness ratio (ICER) of sunitinib compared to IFN-a as first-line treatment for MRCC, defined as the ratio of the incremental cost of treatment over the incremental effectiveness; effectiveness measured as quality adjusted life year (QALY) gain. This objective was not addressed in the clinical study report, but an interim analysis of cost-effectiveness was presented separately. These results were not available for inclusion at the time of this posting.|post study measurement|||ratio|||Number
175067|NCT00083889|Secondary|Plasma Concentrations of Soluble Proteins: Plasma Basic Fibroblast Growth Factor (bFGF) That May be Associated With Tumor Proliferation or Angiogenesis|Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Day 1 & Day 28, Cycle 1 to Cycle 4|Pharmacodynamic analyses performed at selected sites on AT population who had at least one PK (pharmacokinetic) sample; n = subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively. Abbreviations: C = Cycle, D = Day, bFGF: basic fibroblast growth factor.||pg/ml and ratio to Baseline||Standard Deviation|Mean
175068|NCT00083889|Secondary|Plasma Concentrations of Soluble Proteins: Plasma VEGF-A, Plasma VEGF-C, Plasma sVEGFR-3, PLASMA IL-8, and PLASMA bFGF That May be Associated With Tumor Proliferation or Angiogenesis|Plasma concentrations of soluble proteins that may be associated with tumor proliferation or angiogenesis collected from a subset of patients were analyzed by enzyme-linked immunosorbent assay (ELISA) analysis. Soluble protein values: Baseline concentration (pM) and ratio to Baseline at each timepoint; ratio = plasma concentration of soluble protein (picograms per milliliter [pg/ml]) at timepoint / concentration of soluble protein (pg/ml) at baseline. Samples below the limit of quantitation and samples with insufficient volume available were excluded.|Day 1 & Day 28, Cycle 1 to Cycle 4|Pharmacodynamic analyses performed at selected sites on AT population who had at least one pharmacokinetic sample; n= SU011248, INF-α; Abbreviations: C: Cycle, D: Day, VEGF: vascular endothelial growth factor, sVEGFR-3: soluble vascular endothelial growth factor Receptor-3, IL-8: interleukin-8, bFGF: basic fibroblast growth factor.||pg/ml and ratio to Baseline||Standard Deviation|Mean
175069|NCT00083889|Secondary|Euro-QoL Visual Analog Scale (EQ-VAS)|EQ-VAS: overall self-rating rating of the patient’s current health state using a 20 cm Visual Analog Scale (EQ-VAS), also called the health state thermometer) is a metric measurement (in 2 mm interval) from the visual analog scale which ranges between 0 (worse imaginable health state) and 100 (best imaginable health state).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
175070|NCT00083889|Secondary|EuroQoL Five Dimension (EQ-5D) Health State Index|EQ-5D Health State Index: a brief, self-administered generic health status instrument. Respondents were asked to describe their current health state on each of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety or depression) on a three-level scale (1=no problem, 2=some problem, and 3=extreme problem). A maximum score of 1 can be derived from these 5 dimensions by score conversion; range: –0.39 (worst health state)to 1.00 (best health state). This descriptive system classifies respondents into one of 243 possible distinct health states (EQ-5D descriptive system).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
175071|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Functional Well Being (FWB) Subscale|Functional well-being (FWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; higher score indicates greater functional well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT||scores on scale||Standard Deviation|Mean
175072|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Emotional Well Being (EWB) Subscale|Emotional well-being (EWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 24; lower score indicates better emotional well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
175073|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Social/Family Well Being (SWB) Subscale|Social/family well-being (SWB)subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates less social/family well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
175074|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G): Physical Well Being (PWB) Subscale|Physical well-being (PWB) subscale of the Functional Assessment of Cancer Therapy-General (FACT-G). Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = the sum score of the item scores in the subscale; range: 0 to 28; lower score indicates better physical well-being.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
175121|NCT00083122|Primary|Proportion of Confirmed Tumor Responses Defined to be Either a Complete Response (CR) or Partial Response (PR)|"A Complete Response (CR) is defined as the disappearance of all target lesions and normalization of tumor biomarkers.~A Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.~A confirmed tumor response is defined to be either a CR or PR noted as the objective status on 2 consecutive evaluations at least 4-6 weeks apart."|24 weeks|All 45 participants were analyzed.||Percentage of Participants|||Number
175075|NCT00083889|Secondary|Functional Assessment of Cancer Therapy-General (FACT-G)|Functional Assessment of Cancer Therapy-General (FACT-G): core questionnaire of the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system that has been validated in a variety of cancer populations. 27 questions grouped into 4 domains that measure a patient’s physical, functional, social and family, and emotional well-being. Five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Score = sum score of item scores in the subscale; total range: 0 to 108 with higher score indicating better quality of life.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
175076|NCT00083889|Primary|Progression-Free Survival (PFS), Investigator's Assessment|Progression-free survival = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. PFS = first event date minus the date of randomization + 1). On study included treatment plus 28-day follow-up periods.|Day 28 of each 6-week cycle: duration of treatment phase|ITT||weeks||95% Confidence Interval|Median
175077|NCT00083889|Secondary|FACT-Kidney Symptom Index (FKSI) Subscale|FACT-Kidney Symptom Index (FKSI) subscale designed to be a stand-alone instrument to measure symptoms and quality of life in patients with advanced kidney cancer. Contains 15 questions; some questions overlap with the FACT-G questions. Each question was answered on a five-point Likert-type scale ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Total FKSI score = sum score of the 15 item scores; total range: 0 - 60; 0 (most severe symptoms and concerns) to 60 (no symptoms or concerns).|Day 1 & 28 of each cycle: duration of treatment phase|ITT; N=number of subjects with evaluable data; n=number of subjects with evaluable data at observation.||scores on scale||Standard Deviation|Mean
175078|NCT00083889|Secondary|FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Subscale|FACT-Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) subscale of the FKSI to measure advanced kidney cancer disease related symptoms. Includes 9 items: lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria. Each question was answered on a five-point Likert-type scale ranging from 0 (not at all) to 4 (very much). Score = the sum score of the item scores in the subscale; total range: 0 to 36. A score greater than 0 indicates the difference favored sunitinib.|Day 1 & 28 of each cycle: duration of treatment phase|ITT; summary of FKSI-DRS questionnaire results by treatment; N=number of subjects with evaluable data; n = number of subjects with evaluable data at observation, SU011248 and INF-α treatment groups, respectively.||scores on scale||Standard Deviation|Mean
175079|NCT00083889|Secondary|Duration of Response (DR), Investigator's Assessment|Duration of response (DR) = time from the first documentation of objective tumor response to the first documentaion of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.|Day 28 of each cycle: duration of treatment phase|ITT||weeks||95% Confidence Interval|Median
175080|NCT00083889|Secondary|Duration of Response (DR), Core Radiology Assessement|Duration of response (DR) = time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause. DR data were censored on the day following the date of the last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects without objective tumor progression who did not die due to any cause while on treatment or who were given anti-tumor treatment other than study treatment prior to observing tumor progression.|Day 28 of each cycle: duraton of treatment phase|ITT||weeks||95% Confidence Interval|Median
175081|NCT00083889|Secondary|Time to Tumor Progression (TTP), Investigator's Assessment|TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than the study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.|Randomization to first documentation of tumor progression: duration of treatment phase|ITT||weeks||95% Confidence Interval|Median
175082|NCT00083889|Secondary|Time to Tumor Progression (TTP), Core Radiology Assessment|TTP = time from randomization to first documentation of objective tumor progression. TTP data were censored on the day following the date of last on treatment (including 28 day follow-up period) tumor assessment documenting absence of progressive disease for subjects who did not have objective tumor progression while on treatment or who were given anti-tumor treatment other than study treatment prior to documentation of objective tumor progression. Subjects with no tumor assessments after randomization had TTP censored on the date of randomization with a duration of 1 day.|Randomization to first documentation of tumor progression: duration of treatment phase|ITT||weeks||95% Confidence Interval|Median
175083|NCT00083889|Secondary|Overall Survival (OS)|Overall survival (OS) = time from date of randomization to date of death due to any cause. For patients not expiring, survival time was censored at the last date they were known to be alive. Patients lacking data beyond randomization had their survival times censored at the date of randomization with a duration of 1 day.|Clinic visit or telephone contact every 2 months until death|ITT||weeks||95% Confidence Interval|Median
175084|NCT00083889|Secondary|Objective Response, Investigator's Assessment|Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses = those that persist on repeat imaging study >= 4 weeks after initial documentation of response.|Day 28 of each 6-week cycle: duration of treatment phase|ITT||participants|||Number
175122|NCT00082888|Secondary|Toxicity|Number of patients that experienced a grade 3 or 4 toxicity (adverse events considered at least possibly related to Tipifarnib) as measured by NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) v3.0|3/26/2004 - 2/1/2011||||||
175085|NCT00083889|Secondary|Objective Response, Core Radiology Assessment|Objective response (OR) = the number of patients with confirmed complete response (CR) and confirmed partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, relative to all randomized patients. CR was defined as the disappearance of all target lesions. PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. Confirmed responses (CR or PR) = those that persisted on repeat imaging study >= 4 weeks after initial documentation of response.|Day 28 of each 6-week cycle: duration of treatment phase|ITT||participants|||Number
175086|NCT00083889|Primary|Progression-Free Survival (PFS), Core Radiology Assessment|Progression-free survival (PFS) = time from randomization to first documentation of objective tumor progression or to death due to any cause, whichever occured first. If tumor progression data included more than 1 date, the first date was used. PFS = first event date minus the date of randomization + 1. On study included treatment plus 28-day follow-up periods.|Day 28 of each 6-week cycle: duration of treatment phase|Intent to treat (ITT) population: all patients who were randomized, with study drug assignment designated according to initial randomization, regardless of whether patients received study drug or received a different drug from that to which they were randomized.||weeks||95% Confidence Interval|Median
175087|NCT00083759|Secondary|American College of Rheumatology (ACR)70|≥70% reduction from baseline in painful/tender joint count and swollen joint count and ≥70% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6|||participants|||Number
175088|NCT00083759|Secondary|American College of Rheumatology (ACR)50|≥50% reduction from baseline in painful/tender joint count and swollen joint count and ≥50% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6|||participants|||Number
175089|NCT00083759|Primary|American College of Rheumatology (ACR)20.|≥20% reduction from baseline in painful/tender joint count and swollen joint count and ≥20% improvement in at least three of five secondary clinical parameters (e.g., subject global assessment, physician global assessment, pain scale, disability score, and an acute phase reactant)|Month 6|||participants|||Number
175090|NCT00083720|Primary|Number of Participants With Serious Adverse Events|Reported SAEs per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities. The NCI-CTCAE Version 3.0 was used to grade all SAEs. An SAE was any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, was life threatening, required inpatient hospitalization or caused prolongation of existing hospitalization,congenital anomaly/birth defect, or any important medical event.|A serious adverse event (SAE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses.||Participants|||Number
175091|NCT00083720|Primary|Number of Participants With Adverse Events|Reported adverse events (AEs) per patient were coded according to the corresponding preferred term and system organ class in the Medical Dictionary for Regulatory Activities dictionary. The National Cancer Insititute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0 was used to grade all AEs. The collection of AEs began at the time the patient received the first cetuximab dose and continued during the study until 30 days after the last dose of cetuximab. All patients who were enrolled and treated with cetuximab were assessed for safety (mITT population, as treated).|An adverse event (AE) was included in the safety analysis if its onset date occurred anytime during cetuximab treatment or up to 30 days after the last dose of cetuximab.|Patients who were enrolled and treated with any quantity of cetuximab constitute the mITT population. Since this trial was a single arm trial, the mITT population used for the efficacy analyses was also used for the safety analyses.||Participants|||Number
175092|NCT00083720|Secondary|Overall Survival|This measure is defined as the time from the first day of therapy to the date of death. Survival of living patients or those lost to follow-up were censored on the last date the patients were known to be alive.|Survival information was collected every 3 months after completion of therapy and/or follow-up up to 24 months.|Overall survival was calculated from the time of the first day of therapy to the date of death for the mITT population.||Months||95% Confidence Interval|Median
175093|NCT00083720|Secondary|Time to Progression|This measure was defined as the time from the first day of treatment until the date of PD. Deaths without objective progression were censored. Patients who did not progress were censored at their last day of tumor assessment.|Patients with PD after receiving at least one standard chemotherapeutic regimen that included a fluoropyrimidine (range: 1-3 months).|This measure was calculated for the mITT population.||Months||95% Confidence Interval|Median
175094|NCT00083720|Secondary|Duration of Response|In patients with a best overall response of CR or PR, the duration of response is measured from the date criteria are first met for CR or PR, until the first date that Progressive Disease (PD) is objectively documented or death occurs. Duration of response of living patients with no evidence of PD was censored on the date of their last tumor assessment.|The duration of response was measured from the date of response to the first date of PD (range 2 to 7 months).|The duration of response was calculated for the subgroup of the mITT population who demonstrated a response.||Months||95% Confidence Interval|Median
175095|NCT00083720|Secondary|Percentage of Participants With Disease Control (CR, PR, or SD)|This is the total number of patients with a best overall response of CR, PR, and stable disease (SD) divided by the total number of patients treated.|Tumor evaluations were performed at a minimum of every 6 weeks while on cetuximab therapy. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation demonstrating a response.|Disease control rate was the total number of patients with best overall response of CR, PR and SD divided by the total number of patients treated.||Percentage of participants||95% Confidence Interval|Mean
175123|NCT00082888|Secondary|Duration of Response|Duration of response is defined for all evaluable patients that have achieved an objective response as the date at which the patient's objective status is first noted to be either a complete response or partial response to the date progression is documented.|up to 2 years||||||
175096|NCT00083720|Primary|Percentage of Participants With an Overall Resonse|Determine the response rate (complete response [CR] and partial response [PR]) in patients with epidermal growth factor receptor (EGFR)-negative metastatic colorectal carcinoma treated with cetuximab, as classified by the investigator according to the World Health Organization (WHO) criteria. The calculation was the total number of patients with CR or PR divided by the total number of patients treated.|Tumor evaluations were performed at a minimum every 6 weeks while on cetuximab therapy until progressive disease (PD) or recurrence. Patients with a PR or CR had a confirmatory tumor assessment no less than 4 weeks after the initial evaluation.|The overall response rate was calculated for the modified Intent to Treat (mITT) population.||percentage of participants||95% Confidence Interval|Mean
175097|NCT00083616|Secondary|Overall Survival|Kaplan-Meier estimate of median time from enrollment to death from any cause. Deaths were recorded during treatment, safety follow-up and long term follow-up.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||months||95% Confidence Interval|Median
175098|NCT00083616|Secondary|Duration of Stable Disease|Kaplan-Meier estimates of the median time from enrollment to the date of first observed disease progression or death due to disease progression among those participants with a best outcome of stable disease. Stable disease (SD): Neither sufficient shrinkage of Index lesions to qualify for partial response nor sufficient increase to qualify for progressive disease (PD) taking as reference the nadir sum of the products of the longest diameters (SPD) since the treatment started and the disappearance of or persistence of one or more non-index lesions not qualifying for PD.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), with a best outcome of stable disease||Weeks||95% Confidence Interval|Median
175099|NCT00083616|Secondary|Time to Treatment Failure|Kaplan-Meier estimate of median time from enrollment to treatment failure, defined as the date the decision was made to end treatment. Participants remaining in the treatment phase at the time of the analysis were censored on their last visit date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||Weeks||95% Confidence Interval|Median
175100|NCT00083616|Secondary|Time to Disease Progression|Kaplan-Meier estimate of the median time from enrollment to first observed disease progression or death if death was due to disease progression (whichever comes first). Participants who did not progress while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||Weeks||95% Confidence Interval|Median
175101|NCT00083616|Secondary|Progression-free Survival Time|Kaplan-Meier estimate of median time from enrollment to death or first observed disease progression (whichever comes first). Participants who did not progress while on study and did not die while on study were censored at the last evaluable disease assessment date.|Until the data cut-off date of 22 December 2006. Maximum follow-up time was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||Weeks||95% Confidence Interval|Median
175102|NCT00083616|Secondary|Time to Response|Median time from enrollment to objective tumor response for participants who responded.|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Subset of Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed objective tumor response||Weeks||Inter-Quartile Range|Median
175103|NCT00083616|Secondary|Number of Participants With Objective Tumor Response Throughout Study|Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, throughout the duration of the study Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no “unequivocal progression” of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||Participants|||Number
175104|NCT00083616|Primary|Duration of Response|The time from first objective response to first observed progression of disease or death if the death was due to disease progression (whichever comes first); participants who respond and have not progressed while on study or died for reasons other than disease progression while on study were censored at their last evaluable disease assessment date. Response (complete or partial response) was assessed per modified WHO criteria by the central IRC. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no “unequivocal progression” of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.|Until the data cut-off date of 22 December 2006. Maximum time of follow-up was 128 weeks.|Subset of the Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC), who had a confirmed obective tumor response||Weeks||95% Confidence Interval|Median
175124|NCT00082888|Secondary|Time to Progression|Time to progression was defined as the number of months from registration to the date of disease progression with patients being progression-free being censored on the date of their last evaluation.|up to 2 years||||||
175125|NCT00082888|Secondary|Overall Survival|Overall survival time was defined as the time from registration to the date of death or last follow-up.|Up to 2 years||||||
176504|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 16|Percentage of participants with Viral Load < 400 copies/mL|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
175105|NCT00083616|Primary|Number of Participants With Objective Tumor Response Through Week 16|Confirmed objective tumor response (complete or partial response) based on modified World Health Organization (WHO) criteria, through week 16. Tumor response was assessed by a central Independent Review Committee (IRC) and confirmation 4 weeks after initial assessment was required. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the sum of the product of the longest diameters (SPD) of index lesions taking as reference the Baseline SPD, and no new non-index lesions and no “unequivocal progression” of non-index lesions, or, the disappearance of all index lesions and persistence of one or more non-index lesions not qualifying for either CR or Progressive Disease.|16 weeks|Adjudicated Prior Failures Set, composed of participants confirmed to be eligible by the Independent Eligibility Review Committee (IERC)||Participants|||Number
175106|NCT00083551|Primary|Overall Survival|Overall Survival at six years after initiating protocol therapy|6 Years|||percentage of participants|||Number
175107|NCT00083382|Primary|Best Response|"Best response to study treatment as defined by protocol-specific response criteria:~Complete Response (CR) = absence of urine and serum M-components by immunofixation; bone marrow should be adequately cellular (>20%) with <1% monoclonal plasma cells by DNA-clg flow cytometry; serum calcium level must be normal; no new bone lesions nor enlargement of existing lesions; Normalization of serum concentrations of normal immunoglobulins is not required for CR. Partial Response (PR) = Reduction by > 75% in serum myeloma protein production; Decrease in monoclonal marrow plasmacytosis to <5%; Decrease in Bence-Jones proteinuria by >90%; No new lytic bone lesions or soft tissue plasmacytoma.~Treatment Failures/Progressive Disease (PD) = Such patients do not fulfill the above criteria and/or have new lytic lesions (but not compression fractures), hypercalcemia, or other new manifestations of disease."|2 years|||participants|||Number
175108|NCT00083226|Secondary|Progression Free Survival|Time from registration to disease progression or death, whichever occurred earlier. Patients alive and progression-free were censored at last follow up. 36 eligible and treated patients were included in the analysis. The other 2 eligible and treated patients had no disease status information.|assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year.|eligible and treated patients with progression status information||months||95% Confidence Interval|Median
175109|NCT00083226|Secondary|Overall Survival|Overall survival is defined as time from registration to death from any cause. Patients alive were censored at follow up. Analysis was conducted in the 38 eligible and treated patients.|assessed every 3 months for 2 years and then every 6 months for 1 year|eligible and treated||months||95% Confidence Interval|Median
175110|NCT00083226|Primary|Objective Response Rate Measured by Response Evaluation Criteria In Solid Tumors (RECIST)|Tumor response was measured by Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Objective response rate included complete response (disappearance of all tumor lesions) and partial response (At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter.).|assessed every 3 cycles while on treatment. After discontinuing treatment, assessed every 3 months for 2 years and then every 6 months for 1 year|eligible and treated patients||percentage of participants||90% Confidence Interval|Number
175111|NCT00083174|Secondary|Incidences of Other Malignancies|Other malignancies includes any other malignancy which is not in breast.|Over study (median follow-up 35 months)|Women who have received treatment||participants|||Number
175112|NCT00083174|Secondary|Incidence of Clinically Relevant Cardiac Events|Events including myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes and all vascular deaths|During protocol treatment (up to 5 years)|Women who received treatment||participants|||Number
175113|NCT00083174|Secondary|Incidence of All Clinical Fractures||During protocol treatment (up to 5 years)|Women who have received treatment||participants|||Number
175114|NCT00083174|Secondary|Number of Clinical Breast Biopsies||Over study (median follow-up 35 months)|Women who had at least one clinical breast biopsy||number of clinical breast biopsies||Full Range|Median
175115|NCT00083174|Secondary|Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events||Over study (median follow-up 35 months)|Intent-to-treat (ITT)||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
175116|NCT00083174|Secondary|Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer|It was estimated from the Total Breast Cancer-Free Survival (TBCFS), which was calculated for women who developed invasive or non-invasive (DCIS) breast cancer as the time from the date of randomization to the earliest date of diagnosis for invasive or non-invasive (DCIS) breast cancer. Women who died from other causes were censored at the time of death. Women who had breast cancer before entry were censored at the time of randomization. If a woman did not develop an invasive or non-invasive (DCIS) breast cancer, or died, TBCFS will be censored on the date of last known alive.|Over study (median follow-up 35 months)|Intent-to-treat (ITT)||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
175117|NCT00083174|Primary|Invasive Breast Cancer Incidence (Breast Cancer-Free Survival)|Invasive breast cancer incidence was estimated from the breast cancer-free survival (BCFS) which was calculated for all women from the day of the randomization to the earliest date of diagnosis for invasive breast cancer. Women who died from other causes were censored at the time of death. If a woman did not develop an invasive breast cancer, or died, BCFS was censored on the date of the last day the woman was known alive (LKA), which was the latest of the date of assessment. Women who had breast cancer before study entry were also censored at the time of randomization.|Over study (median follow-up 35 months)|intention to treat (ITT)||percentage of cases/follow-up person-yr||95% Confidence Interval|Number
175118|NCT00083174|Primary|Frequency of Serious Adverse Events|Frequency of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.|5 years||||||
175119|NCT00083122|Secondary|Time to Progression|Time to progression will be estimated using the method of Kaplan-Meier. Progression is defined as having at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.|Time from registration to the date of progression or last follow-up, assessed up to 3 years|All 40 participants from Group 1 were analyzed. However, due to slow accrual and early closure, Group 2 was not statistically analyzed for this endpoint.||months||95% Confidence Interval|Median
175126|NCT00082888|Primary|Proportion of Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment|Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.|During the first 6 cycles of treatment|||Proportion of confirmed responses||95% Confidence Interval|Number
175127|NCT00082810|Secondary|Median Overall Survival|The 95% confidence intervals will be used.|From randomization until death or censored at the date of last follow-up, assessed up to 4 years|||months||95% Confidence Interval|Median
175128|NCT00082810|Secondary|Toxicity as Assessed by NCI CTCAE Version 3.0|The frequency of serious (grade 3) or life-threatening (grade 4) adverse events in this study will be compared to published data of fulvestrant and tipifarnib alone.|Up to 4 years||||||
175129|NCT00082810|Secondary|Duration of Response|DOR was defined for responders as the time from the onset of first response to disease progression and for non-responders as zero|Up to 4 years|||months||95% Confidence Interval|Median
175130|NCT00082810|Secondary|Time to Progression (TTP)|TTP was estimated using the Kaplan–Meier method.|From randomization until progression of the disease, assessed up to 4 years|||months||95% Confidence Interval|Median
175131|NCT00082810|Primary|Clinical Benefit Rate (CBR) (CR Rate, PR Rate, and SD)|Number of participants met the definition of Clinical Benefit Rate.Tumor response was assessed every three cycles by CT using RECIST (Response Evaluation Criteria In Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.|Up to 24 weeks|||participants|||Number
175132|NCT00082758|Primary|Number of Responders (Response Rate)|Response rate to hu14.18-Interleukin-2 in 3 separate strata of patients with recurrent or refractory neuroblastoma. Patients will have radiologic (CT/MRI) tumor and urine homovanillic acid (HVA)/vanillylmandelic acid (VMA) measurements. Patients with prior marrow involvement will have marrow assessments. Patients with MIBG+ (iodine-131-meta-iodobenzylguanidine) prior disease will have MIBG scans performed. For CT/MRI lesions, measureable disease is measured by the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute. RECIST (v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions.|Up to 30 weeks|Patients were evaluable for inclusion in the analysis of response if eligible, had an event (relapse, PD, death or secondary malignancy) any time after enrollment, or completed at least 2 courses of Irinotecan/Temozolomide therapy. Patients off therapy before completion of 2 courses by choice or toxicity were not evaluable for response analysis.||participants|||Number
175133|NCT00082433|Primary|Overall Survival (OS)|Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.|from date of randomization until death|Analysis was conducted on all randomized patients on an intent to treat basis. This study required at least 846 events (deaths) to ensure the 2-sided, α = 0.05 level, log-rank test to have 90% power to show a statistically significant difference in OS between treatment groups when the hazard ratio (HR) is 0.8.||months||95% Confidence Interval|Median
175134|NCT00082433|Secondary|Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)|Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.|Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment|Analysis was conducted on all randomized participants on an intent to treat basis. (Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)||units on a scale||95% Confidence Interval|Mean
175135|NCT00082433|Secondary|Treatment-Related Safety Summary|Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTC) Version 3.0|safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.|All patients who received at least 1 dose of ixabepilone and/or capecitabine. Participants with baseline hepatic impairment (combination arm, n = 50; capecitabine arm, n = 37), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths observed in study CA163-046.||Participants|||Number
175136|NCT00082433|Secondary|Time to Response|"Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for partial or complete (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure)."|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)||weeks||Full Range|Median
175137|NCT00082433|Secondary|Duration of Response|"Measured from the time RECIST criteria (described in previous outcome measure) were first met for complete or partial response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method."|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated patients with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline)||Months||95% Confidence Interval|Median
175138|NCT00082433|Secondary|Response Rate (RR)|"RR=number of patients in that group whose best response is partial(30% decrease in the sum of the longest diameter of target lesions) or complete (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants"|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|Response-evaluable participants (all treated participants with the correct diagnosis of adenocarcinoma originating in the breast who had measurable disease as determined at baseline).||percentage of participants||95% Confidence Interval|Mean
175139|NCT00082433|Secondary|Progression-Free Survival (PFS)|PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.|every 6 weeks (± 3 days) from randomization while on treatment until documented progression|All randomized patients with measurable disease as stratified at the time of randomization; n=480 and n=480 for the 2 treatment groups, respectively. Analysis was conducted once 903 progressions or deaths were observed in 960 participants.||months||95% Confidence Interval|Median
175140|NCT00082407|Secondary|Change in Rate of Hypoglycemic Events|Change in rate of hypoglycemic events per 30 days per patient from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat||events per 30 days per patient||Standard Error|Least Squares Mean
175141|NCT00082407|Secondary|Percentage of Patients With Hypoglycemic Events|Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 52 week Parent Study divided by the total number of patients who particiapted in the 52 week Parent Study|52 weeks|Intent to Treat||percentage of participants|||Number
175142|NCT00082407|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, after breakfast, pre-lunch, after lunch, pre-dinner, after dinner, 0300 hours) SMBG profile from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat||mmol/L||Standard Deviation|Mean
175143|NCT00082407|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline to week 52|baseline, week 52|Intent to Treat, computed from the patients having both baseline and week 52 data.||mmol/L||Standard Error|Least Squares Mean
175144|NCT00082407|Secondary|Change in Body Weight|Change in body weight from baseline to week 52.|baseline, week 52|Intent to Treat, computed from the patients having both baseline and week 52 data.||kg||Standard Error|Least Squares Mean
175145|NCT00082407|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 52 (percentage = [number of subjects with HbA1c <=7% at week 52 divided by number of subjects with HbA1c >7% at baseline] * 100%).|52 weeks|Last Observation Carried Forward; Intent to Treat||percentage of participants|||Number
175146|NCT00082407|Primary|Change in Glcosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to week 52|baseline, week 52|Last Observation Carried Forward; Intent to Treat, computed from the patients having both baseline and post-baseline data.||percentage||Standard Error|Least Squares Mean
175147|NCT00082381|Secondary|Change in Rate of Hypoglycemic Events|Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26|Baseline, week 26|Intent to Treat||events per 30 days per patient||Standard Error|Least Squares Mean
175148|NCT00082381|Secondary|Percentage of Patients With Hypoglycemic Events|Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study|26 weeks|Intent to Treat||percentage of participants|||Number
175149|NCT00082381|Secondary|Change in 7-point Self-monitored Blood Glucose (SMBG) Profile|Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat||mmol/L||Standard Error|Least Squares Mean
175150|NCT00082381|Secondary|Change in Fasting Serum Glucose|Change in fasting serum glucose from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat||mmol/L||Standard Error|Least Squares Mean
175151|NCT00082381|Secondary|Change in Body Weight|Change in body weight from baseline to week 26|Baseline, week 26|Intent to Treat||kg||Standard Error|Least Squares Mean
175152|NCT00082381|Secondary|Percentage of Patients Achieving HbA1c <=7%|Percentage of patients in each arm who had HbA1c >7% at baseline and had HbA1c <=7% at week 26 (percentage = [number of subjects with HbA1c <=7% at week 26 divided by number of subjects with HbA1c >7% at baseline] * 100%).|26 weeks|Last Observation Carried Forward; Intent to Treat||percentage of participants|||Number
175153|NCT00082381|Primary|Change in Glycosylated Hemoglobin (HbA1c)|Change in HbA1c from baseline to week 26|Baseline, week 26|Last Observation Carried Forward; Intent to Treat, computed from the patients having both baseline and post baseline data||percentage||Standard Error|Least Squares Mean
175154|NCT00082368|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|69 months|||participants|||Number
175155|NCT00082368|Primary|Percent Change in Tc-94m Sestamibi Body Weight Standardized Uptake Value (SUV) Maximum in Tumor Tissue Before and After Administration of Tariquidar, a P-glycoprotein Antagonist.|Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. Significant increase in the SUV in tumor is +25% over baseline.|3 days|||% change in Tc-94m Sestamibi SUVmax||Full Range|Mean
175156|NCT00082355|Secondary|Number of Participants That Developed Hemorrhage|The outcome measures the number of participants who developed hemorrhage after receiving up to 4 days of Alteplase treatment for DVT.|5 days|The number of participants analyzed is an Intent-to-Treat (ITT) population. The accrual target was to analyze outcomes(immediate, at 6 weeks, and at 6months) after treatment of DVT with alteplase in 25 patients. 30 patients were treated but two participants did not complete the study for 6 week and 6 month outcome assessments.||participants|||Number
175448|NCT00076999|Secondary|Number Patients With at Least 1 log10 Viral Load Reduction From Baseline at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
175157|NCT00082355|Primary|Number of Participants With Restored Venous Function|The outcome measures the ability of Alteplase to lyse acute and subacute deep venous thrombosis (DVT) of the lower extremities and/or pelvis and restore venous function, or blood flow, to these areas. Restored venous function is also known as patency. Patency is measured by venography and ultrasound exams.|6 months|The number of participants analyzed is an Intent-to-Treat (ITT) population. The initial goal was to be able to evaluate outcomes of treatment of DVT with alteplase over a 6 month period in 25 patients. 30 patients were treated but two participants did not complete the study before being assessed for this outcome measure.||participants|||Number
175158|NCT00082342|Secondary|Bradykinesia Measure Before and After Real and Sham tDCS.|Bradykinesia refers to the slowness in executing a movement. Bradykinesia was assessed by measuring the time in seconds it takes to do the following sequence, 10 times: 1) hand closing and opening while squeezing a ball 2) elbow flexion 3) hand closing and opening, and 4) elbow extension. Subjects were allowed to practice these hand and arm movements until performance appeared not to get faster, and then were abstained from further practice to minimize learning effects. The time it takes subjects to execute the entire sequence 10 times with either the left or right arm/hand was measured. Means are reported for each group.|baseline, 1 day post, 1 month post, 3 months post tDCS|||seconds||Standard Deviation|Mean
175159|NCT00082342|Secondary|UPDRS Motor Scores Before and After Real tDCS Course and After Sham tDCS Course.|The Motor Unified Parkinson's Disease Rating Scale (UPDRS) includes only the motor assessment of the UPDRS (Part III) and examines speech, facial expression, tremor at rest, action tremor, rigidity, finger taps, hand movements, hand pronation and supination, leg agility, arising from chair, posture, gait, postural stability and body bradykinesia. The scores range from 0 (no motor impairment) to 108 (severe motor impairment). The Motor UPDRS was administred at baseline and at 1 day post, 1 month post, and 3 months post tDCS or sham. Subjects were assessed on medication and off medication.|baseline, 1 day post, 1 month post, and 3 months post real and sham tDCS|||units on a scale||Standard Deviation|Mean
175160|NCT00082342|Secondary|UPDRS Total Scores Before and After Real tDCS Course and After Sham tDCS Course.|The Total Unified Parkinson's Disease Rating Scale (UPDRS) is an overall clinical rating scale that quantifies the signs and symptoms of Parkinson's disease. The total UPDRS score was obtained from subject examination, subject interviews and questionnaires. The UPDRS encompasses measurement of mentation, behavior, mood, activities of daily living and motor skills. The total UPDRS scores ranges from 0 (not affected) to 176 (most severely affected). The UPDRS was administred at baseline and at 1 day post, 1 month post, and 3 months post tDCS or sham, while on medication and off medication.|baseline, 1 day post, 1 month post, 3 months post-tDCS|||units on a scale||Standard Deviation|Mean
175161|NCT00082342|Primary|Gait Speed Before and After Real and Sham tDCS.|Gait speed was measured by the time it took the subject to walk 10m. Subjects were instructed to walk at a fast pace without taking the risk of falling, wearing the same shoes and using assistive devices consistently if needed. Gait speed was measured at baseline and post-tDCS.|baseline, 1 day post, 1 month post, 3 months post-tDCS|Intent to treat||Seconds||Standard Deviation|Mean
175162|NCT00082329|Secondary|To Examine 1) the Cellular Content and Other Immune Properties of Mobilized Cells; 2) Yields of Hematopoietic Progenitor Cells, Immune Cells, and Other Cellular Subsets Collected by Apheresis; and 3) Safety Profile of AMD3100.||Through day 7||||||
175163|NCT00082329|Primary|To Determine the Cytokine Polarization Status of Cluster of Differentiation 4 (CD4)+ T-cells Collected by Apheresis Following Combination of AMD3100 and G-CSF Compared to G-CSF Mobilization.|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization. The successful treatment responders will complete study treatment with cell mobilization and cell collection. Non-responders will have completed the study treatment and have cell mobilization without cell collection."|Day 1 (cells are counted 24 hours after AMD3100)|||participants|||Number
175164|NCT00082173|Secondary|Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications|Proportion of patients with Grade 3 or 4 adverse reactions attributable to study medications|8 weeks|DAIDS Table of Adverse Events||Participants|||Number
175165|NCT00082173|Primary|Proportion of Patients With Sterile Sputum Cultures|Proportion of patients with sterile sputum cultures|8 weeks|Proportion of patients with sterile sputum cultures at week 8||Participants|||Number
175166|NCT00082017|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|76 months|||Participants|||Number
175167|NCT00082017|Primary|Clinical Response Rate|Clinical Response Rate is the percentage of participants with a response assessed by the International Workshop to Standardize Response Criteria. Complete response (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (CRu) is per CR criteria except that if a residual node is >1.5cm, it must have regressed by >75%. Partial response (PR) is no increase in size of nodes, liver or spleen. Progressive disease (PD) is a greater than or equal to 50% increase from nadir. Details re: response criteria, see the protocol link module|74.5 months|||Percentage of participants|||Number
175168|NCT00081939|Primary|Progression-Free Survival (PFS) at 3 Years From Initiation of Study Treatment.|In patients with no confirmed Partial Response, Near Complete Response, or Complete Response, progression was defined as a >25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc. PFS was measured as the time from initial registration to progression/relapse of disease or death from any cause.|3 years|||percentage of participants|||Number
175169|NCT00081861|Primary|Number of Participants With Response (Complete Response or Progressive Disease)|Response criteria according to the International Working Group Recommendations for lymphoma where Complete Response (CR) defined as “complete disappearance” of clinically detectable disease and Progressive Disease defined by disease appearance by complete blood count (CBC), clinical and radiologic findings, and/or sizes of lymph nodes, spleen, and liver. Response measured from first documentation of response to first detection of progression.|After 8 weeks of therapy (4 doses of Avastin and 8 doses of Rituximab),|Two participants received first treatment dose but were not eligible for response.||Participants|||Number
175449|NCT00076804|Primary|Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 24 Months by Study Arm||24 months|||cells/uL||Inter-Quartile Range|Median
175170|NCT00081770|Secondary|Mean Change From Baseline in the Log Viral Load at Treatment Week 2|The difference between viral load levels in the blood at the start of the study and Treatment Week 2, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.|Assessed at Baseline and Treatment Week 2|ITT Population defined as subjects who received at least one dose of study medication||Log10 IU/mL||Standard Deviation|Mean
175171|NCT00081770|Secondary|Virologic Response Rate at Treatment Week 12|Percentage of participants with undetectable hepatitis C RNA (HCV-RNA) at Treatment Week 12|Assessed at Treatment Week 12|ITT Population defined as subjects who received at least one dose of study medication||Percentage of participants|||Number
175172|NCT00081770|Secondary|Mean Change From Baseline in the Log Viral Load at Treatment Week 4|The difference between viral load levels in the blood at the start of the study and Treatment Week 4, expressed in terms of a logarithmic scale with base 10, and averaged for all the participants in each treatment group.|Assessed at Baseline and Treatment Week 4|ITT Population defined as subjects who received at least one dose of study medication||Log10 IU/mL||Standard Deviation|Mean
175173|NCT00081770|Primary|Sustained Virologic Response (SVR) Rate|SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.|Assessed at the end of a 24-week post-treatment follow-up|Intent-to-Treat [ITT] Population defined as subjects who received at least one dose of study medication||Percentage of participants|||Number
175174|NCT00081731|Primary|Need for Renal Replacement Therapy||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
175175|NCT00081731|Primary|30% Reduction of eGFR From Baseline, Persisting for Greater Than or Equal to 60 Days||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
175176|NCT00081731|Primary|Stroke||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
175177|NCT00081731|Primary|Hospitalization for Congestive Heart Failure||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
175178|NCT00081731|Primary|Myocardial Infarction||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
175179|NCT00081731|Primary|Cardiovascular or Renal Death||Measured at every 3 months for the first year and annually thereafter|||participants|||Number
175180|NCT00081731|Primary|Composite Endpoint: Death From Cardiovascular or Renal Causes, Stroke, Myocardial Infarction, Hospitalization for CHF, Progressive Renal Insufficiency, or Permanent Renal Replacement Therapy|Only the first event per participant is included in the composite|Measured at every 3 months for the first year and annually thereafter|||participants|||Number
175181|NCT00081653|Secondary|Relative Percent Change From Baseline of Trough Serum CTX|CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.|Baseline, 6,12, 24 and 36 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||percent change||Standard Deviation|Mean
175182|NCT00081653|Primary|Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)|BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).|Baseline and Months 12, 24 and 36|ITT population: n = number of participants analyzed for the given parameter at the specified visit.||percent change||Standard Deviation|Mean
175183|NCT00081653|Primary|Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD|Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).|Baseline and Months 12, 24 and 36|ITT population; number (n) equals (=) number of participants analyzed at the specified visit.||g/cm^2||Standard Deviation|Mean
175184|NCT00081653|Secondary|Absolute Change From Baseline of Trough Serum CTX|CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.|Baseline, 6, 12, 24 and 36 months|ITT population; n = number of participants analyzed for the given parameter at the specified visit.||ng/mL||Standard Deviation|Mean
175185|NCT00081653|Secondary|Relative Percent Change From Baseline in Mean Total Hip BMD|BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).|Baseline, 12, 24 and 36 months|ITT Population; n = number of participants analyzed for the given parameter at the specified visit.||percent change in BMD||Standard Deviation|Mean
175186|NCT00081653|Secondary|Absolute Change From Baseline in Mean Total Hip BMD|BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).|Baseline and 12, 24 and 36 months|ITT Population; n = number of participants analyzed for the given parameter at the specified visit.||g/cm^2||Standard Deviation|Mean
175187|NCT00081497|Secondary|Proteinuria at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-008-00 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme and 6, 12, and 18 months|ITT population–62 patients had assessments at 6 months, 61 patients had assessments at 12 months, and 54 patients had assessments at 18 months in the open-label extension study.||urine protein(mg/dL) / creatinine(mg/dL)||Standard Deviation|Mean
175188|NCT00081497|Secondary|Plasma Globotriaosylceramide (GL-3) (Normal Plasma GL-3 Level is ≤ 7.03 µg/mL) at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL00800 for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL00800; assessment prior to first Fabrazyme infusion in AGAL02503 for placebo patients who did not transition to Fabrazyme in AGAL00800.|Pre-Fabrazyme and 6, 12, and 18 months|ITT population–64 patients had assessments at 6 and 18 months while 65 patients had assessments at 12 months in the open-label extension study.||µg/mL||Standard Deviation|Mean
175189|NCT00081497|Secondary|Estimated Glomerular Filtration Rate (eGFR) at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-00-800 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme, 6, 12, and 18 months|ITT population–67 patients had assessments at 6 and 12 months while 65 patients had assessments at 18 months in the open-label extension study.||ml/min/1.73m^2||Standard Deviation|Mean
175190|NCT00081497|Secondary|Serum Creatinine at Pre-Fabrazyme and 6, 12, and 18 Months|Pre-Fabrazyme=baseline visit of AGAL-008-00 (NCT00074984) for Fabrazyme patients; assessment prior to open-label for placebo patients who transitioned to Fabrazyme in AGAL-008-00 (NCT00074984); assessment prior to first Fabrazyme infusion in AGAL02503 (NCT00081497) for placebo patients who did not transition to Fabrazyme in AGAL-008-00 (NCT00074984).|Pre-Fabrazyme, 6, 12, and 18 months|ITT population–67 patients had assessments at 6 and 12 months while 65 patients had assessments at 18 months in the open-label extension study.||mg/dL||Standard Deviation|Mean
175191|NCT00081497|Post-Hoc|Differences in Slopes of Estimated Glomerular Filtration Rate (eGFR) Comparing Randomized Placebo vs Fabrazyme Patients (Based on the Original Randomization in AGAL-008-00 (NCT00074984)) by Baseline eGFR Subgroups of >60 and ≤60 mL/Min/1.73 m^2.|Summary of differences in slopes of eGFR comparing randomized placebo vs Fabrazyme patients by baseline eGFR subgroups. Differences in slopes are the placebo slope minus the Fabrazyme slope. Therefore, a negative difference indicates a greater decline in the placebo patients relative to the Fabrazyme patients.|Throughout study; 18 months|ITT population. For subgroup Estimated Glomerular Filtration Rate (eGFR) >60, there were 9 placebo patients and 15 Fabrazyme patients. For subgroup eGFR ≤60, there were 19 placebo patients and 24 Fabrazyme patients. For randomized Fabrazyme patients, both the double-blind and open-label data was used.||mL/min/1.73m^2/year||Standard Error|Least Squares Mean
175192|NCT00081497|Primary|Difference in Inverse Serum Creatinine Within Patients' Slopes Between the Placebo AGAL-008-00 (NCT00074984) and Fabrazyme AGAL02503 (NCT00081497) Periods|The primary efficacy analysis was the summary of change in slope of inverse serum creatinine for Placebo/Fabrazyme patients in the Intent to Treat (ITT) Population. It compared the placebo period slope with the Fabrazyme period slope.|Placebo period AGAL-008-00 (up to 35 months) through Fabrazyme period AGAL02503 (18 months)|ITT Population - Analysis compares results during the placebo period with those during the Fabrazyme period and includes only the 28 patients who were randomized to placebo in the AGAL-008-00 (NCT00074984) study; as such no formal sample size calculations were performed.||dL/mg/year||Standard Error|Least Squares Mean
175193|NCT00081458|Secondary|Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24|An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.|6 months of treatment|||participants|||Number
175194|NCT00081458|Primary|A Graded Response Score in Parenteral Nutrition (PN) Reduction|"The intensity of the response relied on a reduction from Baseline in weekly parenteral nutrition (PN) volume (minimum reduction of 20% and a maximum of 100%). Duration of the response incorporated responses at Weeks(Wk) 16-20 and at Wk20-24.~Zero (0 - lowest) assigned if <20% reduction at Wk20-24 and reduction at Wk16-20 of < 20%, 20-39%, or >=40%.~One (1) assigned if reduction of 20-39% at Wk20-24 but < 20% at Wk16-20. Two(2) assigned if reductions of 40-99% at Wk20-24 AND <20% at Wk16-20 OR 20-39% at Wk20-24 AND 20-39% at Wk16-20.~Three (3) assigned if reductions of 100% at Wk20-24 AND <20% at Wk16-20 OR 40-99% at Wk20-24 AND 20-39% at Wk16-20 OR 20-39% at Wk20-24 AND >=40% at Wk16-20.~Four (4) assigned if reductions of 100% at Wk20-24 AND 20-39% at Wk16-20 OR 40-99% at Wk20-24 AND >=40% at Wk16-20."|6 months|Intent to Treat (ITT) analysis using a stepdown procedure that was stopped if the 0.10 mg/kg dose was not significantly better than placebo.||participants|||Number
175195|NCT00081328|Secondary|Comorbidity -- Triglycerides Dyslipidemia|A diagnosis was made by an out-of-range value >=150 mg/dL sustained over 6 months or on appropriate lipid lowering medication.|Data collected at baseline and during follow-up.|Entire cohort.||participants|||Number
175196|NCT00081328|Secondary|Comorbidity -- LDL Dyslipidemia|A diagnosis was made from out-of-range value >= 130 mg/dL sustained over 6 months or put on lipid lowering medication.|Data collected at baseline and during follow-up.|Entire cohort.||participants|||Number
175197|NCT00081328|Secondary|Comorbidity -- Hypertension|A diagnosis was made by an out-of-range value >=95th percentile or systolic >=130 or diastolic >=80 sustained over 6 months or on an anti-hypertensive medication.|Data collected at baseline and during follow-up.|Entire cohort.||participants|||Number
175198|NCT00081328|Secondary|Body Composition -- Fat Mass|Determined by DXA whole body scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.|24 months|Members of the cohort measured at 24 months who did not experience treatment failure.||kg||Standard Deviation|Mean
175199|NCT00081328|Secondary|Body Composition -- Bone Density|Measured by DXA, both whole body scan and AP-spine scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.|24 months|Members of the cohort measured at 24 months who did not experience treatment failure.||g/cm squared||Standard Deviation|Mean
175200|NCT00081328|Secondary|Body Composition -- Waist Circumference|Waist circumference (cm) measured at the iliac crest at its outermost point with the measuring tape placed around the participant in a horizontal plane parallel to the floor at the mark and the measurement teken at the end of normal expiration without the tape compressing the skin. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Members of cohort measured at 24 months who had not experience treatment failure.||cm||Standard Deviation|Mean
175450|NCT00076804|Primary|Immunological Response: Median CD4 (IQR) Cell Count Increase From Baseline at 12 Months by Study Arm||12 months|||cells/uL||Inter-Quartile Range|Median
175202|NCT00081328|Secondary|Insulin Secretion|Insulinogenic index determined from OGTT as difference in insulin at 30 minutes minus 0 minutes divided by difference in glucose at 30 minutes minus 0 minutes. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Participants who were measured at 24 months and had not experience treatment failure.||uU/mL divided by mg/dL||Inter-Quartile Range|Median
175203|NCT00081328|Secondary|Safety|Number of serious adverse events reported during the trial. Participant could have multiple episodes reported.|Reported as occurred during study follow-up.|Entire cohort.||episodes of serious adverse event|||Number
175204|NCT00081328|Secondary|Insulin Sensitivity|All participants were followed to 24 months. Insulin sensitivity is measured from OGTT as inverse of fasting insulin (mL/uU). The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.|24 months|Participants who were measured at 24 months and had not experienced treatment failure.||mL/uU||Inter-Quartile Range|Median
175205|NCT00081328|Primary|Treatment Failure (Loss of Glycemic Control)|Defined as A1c persistently >=8% over a 6-month period or persistent metabolic decompensation (inability to wean insulin within 3 months of initiation or the occurrence of a second episode within three months of discontinuing insulin)|6 months|The entire cohort of 699 participants was included in the analysis.||participants|||Number
175206|NCT00081289|Secondary|Quality of Life as Assessed After Completion of Chemoradiotherapy and Adjuvant Chemotherapy and Then at 2 Years||From randomization to 3 timepoints: 1) completion of chemoradiation, 2) completion of post-operative chemotherapy (approximately 1 year), and 3) two years||||||
175207|NCT00081289|Secondary|Tumor Marker Evaluation Using Preoperative Tissue Biopsy Specimens and Surgically Resected Tissue Specimens||End of study||||||
175208|NCT00081289|Secondary|Incidence of Hematologic and Non-hematologic Grade 3-4 Toxicity (Preoperatively, Postoperatively, and Overall)||Three time frames: start of treatment to surgery, surgery to end of follow-up, and combined.||||||
175209|NCT00081289|Secondary|Time to Treatment Failure and Patterns of Failure||From randomization to date of local failure, regional failure, distant failure, death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.||||||
175210|NCT00081289|Primary|Pathologic Complete Response Rate|"A pathologic complete response (pCR) was defined as no evidence of residual cancer histologically; disease progression or death before surgery was considered less than pCR (even without surgical specimen). All cases were reviewed by the study’s surgical oncology co-chair for the determination of pCR.~Each arm was first analyzed alone. If the arm had 9 or more pCRs in 48 evaluable pts, then the null hypothesis (H0) of 10% pCR rate would be rejected in favor of the alternative hypothesis of 25%, providing 90% power with a two-sided 10% type I error rate. If both arms reject H0, then statistical selection theory would be used to choose the arm for further study in a phase III trial. If only one arm has acceptable pCR rate, then that arm would be pursued in a phase III trial."|After protocol surgery|For each arm the first 48 eligible enrolled after the protocol amendment.||percentage of participants||95% Confidence Interval|Number
175211|NCT00081159|Other Pre-specified|Overall Survival (OS)|Overall Survival defined as the length of time from the start of treatment till time that participants are still alive.|Up to 90 months|Intent to treat population analysis.||Months||95% Confidence Interval|Median
175212|NCT00081159|Secondary|Major Bone Scan Response|Bone scan performed at baseline and at Week 13 provided if baseline scan was positive for metastases. A major bone scan response was considered with a substantial resolution of participant bone metastases on the bone scans, i.e. complete resolution of the osseous metastases on the bone scan.|Week 13|Five participants in the non-Strontium arm were not evaluable for this outcome, four withdrew prior to treatment, and one had disease progression that precluded inclusion. Two participants in the Strontium arm were lost to follow up therefore excluded from analysis as well.||participants|||Number
175213|NCT00081159|Primary|Progression Free Survival (PFS)|Study’s primary endpoint of PFS duration/time to progression was defined as the time from the date of randomization to the date of first evidence of disease progression or patient death. Prostate-specific antigen (PSA) progression is usually the first evidence of progression. PSA progression is defined as a 25% increase over the baseline or the nadir provided that the increase is a minimum of 1 ng/ml.|Up to 90 months with evaulation in 4 week intervals for up to 6 months of treatment, then follow up until disease progression|Intent to treat population analysis.||Months||95% Confidence Interval|Median
175214|NCT00080938|Secondary|Overall Survival Time|Overall survival (months) was calculated from time of protocol entry to time of death from any cause. Patients alive at last follow-up were censored. The 21 eligible and treated patients were included in the analysis.|assessed every 3 months for 2 years|Eligible and treated patients||months||95% Confidence Interval|Median
175215|NCT00080938|Secondary|Time to Non-CNS (Systemic) Progression|Time to non-CNS progression was calculated from time of protocol entry to time of first systemic progressive disease or death. Patients alive and non-CNS progression-free at last follow-up were censored. Disease progression was defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter (per RECIST criteria). Development of new lesions in non-CNS sites also constituted non-CNS progression. The 21 eligible and treated patients were included in the analysis.|assessed every 3 months for 2 years|Eligible and treated patients||months||95% Confidence Interval|Median
175216|NCT00080938|Secondary|1-year Neurologic (Central Nervous System, CNS) Progression Free Rate|1-year CNS progression free rate is the percentage of patients who had no CNS progression after being followed for 1 year . Progressive disease (CNS) was defined as a 25% or greater increase in the sum of the product(s) of the maximal cross-sections on MRI scan, reappearance of any lesion that has disappeared, development of any new lesion(s), stable disease with a deterioration of neurologic exam, or clear worsening of any evaluable disease.|assessed every 3 months for 2 years|Eligible, treated patients||percentage of participants||95% Confidence Interval|Number
175233|NCT00080301|Secondary|Duration of Response Per IRRC|"Computed for all patients with a best response of Partial or Complete per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death."|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|Results for duration of response apply to only those subjects with a response (defined as complete or partial response).||months||95% Confidence Interval|Median
175217|NCT00080938|Primary|Number of Patients With Intracranial Response|Response was assessed per Response Evaluation Criteria in Solid Tumor (RECIST) by brain MRI in the 21 eligible and treated patients.Complete response (CR): complete disappearance of the clinically detectable malignant brain metastasis(es) being followed on MRI scan off corticosteroids and a stable or improving neurologic exam. Partial response (PR): greater than or equal to a 50% reduction in the sum of the product(s) of the maximal cross-sections on MRI scan with a stable or decreasing dose of corticosteroids and a stable or improving neurologic exam. Response = CR + PR|assessed every cycle while on treatment, then every 3 months for 2 years|Eligible and treated patients||participants|||Number
175218|NCT00080912|Primary|Pain Relief Measured by the Brief Pain Inventory at 2 Months After Treatment|The primary endpoint of this study is Overall Response Rate (complete response and partial response) at two months after the first fraction of re-irradiation; patients with a third radiation treatment (the second re-irradiation) before month two will not have response attributed to the study treatment.|2 months|Intend to treat (ITT) population||percentage of response||95% Confidence Interval|Number
175219|NCT00080899|Secondary|Time to PSA Progression|Was summarized using the product-limit (Kaplan-Meier) method. In patients whose PSA levels initially decreased, PSA progression was defined as a 25% increase over the nadir (postenrollment PSA value up to that point), and an increase in the absolute value in the PSA value of 5 ng/mL, relative to the lowest postenrollment PSA value up to that point, including the baseline PSA level – and which was confirmed by second value 3-4 weeks later. A best response of PSA-PD was recorded for those patients who did not achieve a confirmed PSA-N or PSA-PR and who experienced PSA progression within 3 months of start of treatment.|From the start of treatment until the date of the first documentation of PSA progression, assessed up to 5 years|||months||95% Confidence Interval|Mean
175220|NCT00080899|Primary|PSA Response|PSA normalization (PSA-N) was recorded as the best PSA response when a PSA level was undetectable (< 0.1 ng/ml), and was then subsequently confirmed by a second measurement ≥ 4 weeks later. PSA partial response (PSA-PR) was recorded if the PSA decreased by ≥ 50% from pre-treatment or baseline values and was confirmed by a second measurement made ≥ 4 weeks later. Response = PSA-N + PSA-PR.|Baseline to 5 years|||participants|||Number
175221|NCT00080535|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|12/31/2004 - 8/17/2011|||Participants|||Number
175222|NCT00080535|Primary|Response Rate|Response is assessed by the International Workshop's Response Criteria (IWRC) for Non-Hodgkin's Lymphomas which favors the sum of the bidimensional products for tumor measurements. Complete response is no evidence of disease. Complete response unconfirmed (CRu) is a complete response in every category except CRu in lymph nodes. Partial response is a partial response in every measurable category with non-progressive disease elsewhere. Progressive disease is progressive disease in every category. Stable disease is neither partial response nor progressive disease. For additional details about the IWRC see the protocol link module.|Patients were followed for at least 30 days after last treatment. Because the protocol allows 6 treatment cycles, this can be up to 7 months.|||Participants|||Number
175223|NCT00080483|Other Pre-specified|Increased Cortical Thickness and Cortical Density, as Determined by Peripheral Quantitative Computed Tomography of the Tibial Metaphysis||2 years||||||
175224|NCT00080483|Other Pre-specified|Improved Architectural Parameters of Trabecular Bone Reflecting Connectivity, as Determined by Magnetic Resonance Imaging||2 years||||||
175225|NCT00080483|Other Pre-specified|Increased Trabecular Thickness, as Determined by Magnetic Resonance of the Distal Tibia||2 years||||||
175226|NCT00080483|Primary|MicroMRI-derived Structural (Bone Volume Fraction-BVF) of the Distal Tibia at Baseline and After One and Two Years of Treatment.|Increased bone volume fraction (the fraction of bone that is bone, as opposed to the fraction that is marrow), as determined by magnetic resonance of the distal tibia|baseline, one year, two years|All subjects who had both baseline and one year evaluations||unitless||Standard Error|Mean
175227|NCT00080470|Primary|Freedom From Major Complications||5 years|||Number of Adverse Events|||Number
175228|NCT00080470|Primary|Number of Leaks Per Day||12 months|||Number of Leaks Per Day||Standard Deviation|Mean
175229|NCT00080301|Secondary|Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)|Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.|Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.|Analysis was conducted on all randomized participants on an intent to treat basis.(Note: while table only reports data up to 24 wks, which represents most results, statistical analysis includes ALL assessments through study and follow-up; a few participants were assessed after more than 100 weeks.)||units on a scale||95% Confidence Interval|Mean
175230|NCT00080301|Secondary|Treatment-related Safety Summary|Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0|safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.|All treated participants; all participants who received at least 1 dose of study therapy.Participants with baseline hepatic impairment (combination arm, n = 29; capecitabine arm, n = 35), defined as Grade ≥2 AST, ALT or Grade ≥1 total bilirubin, were contraindicated due to disproportionate number of toxic deaths.||Participants|||Number
175231|NCT00080301|Secondary|Overall Survival (OS)|OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.|from date of randomization until death|Overall survival was analyzed on all randomized patients on an intent to treat basis.||Months||95% Confidence Interval|Median
175232|NCT00080301|Secondary|Time to Response Per IRRC|Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|Results for time to response apply to only those subjects with a response (defined as complete or partial response)||weeks||Full Range|Median
175234|NCT00080301|Secondary|Overall Response Rate (ORR) Per IRRC|"Participants with best response of Complete or Partial according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions"|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|The analysis of ORR was conducted on all randomized patients on an intent to treat basis.||percent||95% Confidence Interval|Mean
175235|NCT00080301|Primary|Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)|PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn’t progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.|based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity|PFS was analyzed on all randomized patients on an intention to treat basis.||Months||95% Confidence Interval|Median
175236|NCT00080288|Primary|Clinical Global Impression of Change (CGI-C)|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|up to 12 weeks|"Safety Analysis set of 245 total patients: 9 participants withdrew after randomization but prior to receiving study drug~Full Analysis set of 216 total patients: 29 patients that had withdrawn from the study were non-evaluable for efficacy."||Participants|||Number
175237|NCT00080288|Primary|Multiple Sleep Latency Test (MSLT)|The Multiple Sleep Latency Test (MSLT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. Mean sleep latency from MSLT was measured for five 20-minute (maximum) MSLT naps performed at scheduled visits (2400 [midnight], 0200, 0400, 0600, and 0800).The MSLT was administered at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MSLT sleep latency as assessed at week 12 (or last postbaseline visit).|up to 12 weeks|"Safety Analysis set of 245 total patients: 9 participants withdrew after randomization but prior to receiving study drug~Full Analysis set of 216 total patients: 29 patients that had withdrawn from the study were non-evaluable for efficacy."||Minutes||Standard Deviation|Mean
175238|NCT00080223|Secondary|Overall Survival|Survival was analyzed as time from first study dose to death (all-cause mortality) with surviving participants censored at their last available assessment.|First dosing of study treatment until death (up to 604 weeks)|All treated participants||weeks||95% Confidence Interval|Median
175239|NCT00080223|Secondary|Resting Oxygen Saturation by Pulse Oximetry (SpO2)|SpO2 is the percentage of oxygen saturation in the blood. Oxygen level (oxygen saturation) of the blood was measured using pulse oximetry on room air.|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.||percentage of oxygen saturation||Standard Deviation|Mean
175240|NCT00080223|Secondary|Hemoglobin (Hgb)-Corrected Percent-Predicted Carbon Monoxide Diffusing Capacity (DLco)|DLco is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. Predicted DLco is based on a formula using sex, age and height of a person. Predicted DLco = [Hbg-corrected DLco value (in milliliters per minute per millimeter mercury [mL/min/mmHg])/predicted DLco] * 100%|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.||percent predicted DLco||Standard Deviation|Mean
175241|NCT00080223|Secondary|Percent Predicted Forced Vital Capacity (FVC)|FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out from the lungs after full inspiration in the upright position, measured in liters. Predicted FVC is based on a formula using sex, age and height of a person, and is an estimate of healthy lung capacity. Percent of predicted FVC = (actual FVC value in liter)/(predicted FVC) * 100%|Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432, 456, 480|All treated participants. “n” = participants who were evaluable for specified time point.||percent predicted FVC||Standard Deviation|Mean
175242|NCT00080223|Primary|Percentage of Participants With a Treatment-Emergent Adverse Event (AE), Serious AE (SAE), Severe AE, Life-threatening AE, Death or Discontinuation Because of an AE|An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified as severe (Grade 3) in following cases: marked limitation in activity; some assistance usually required; medical intervention/ therapy required, hospitalization possible. Treatment-emergent AEs were those occurring on or after the first dosing day and up to 28 days after discontinuation of study treatment, and those occurring before treatment that worsened after the first study dose. AE included serious as well as non-serious AEs.|Baseline to 28 days after the last dose of study treatment (maximum duration of treatment in study was 604 weeks)|All treated participants||percentage of participants|||Number
175243|NCT00080119|Secondary|Time From Randomization to First New Grade 3 or Worse Adverse Event Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Signs, symptoms and laboratory values were graded according to the Division of AIDS Adverse Event Grading System. Any event of grade 3 or higher not present at entry that occurred after randomization was classified as a new event. Results report percent of participants with a new event by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting treatment. Time from randomization to first new adverse event (AE) calculated. For lab toxicities, censored at visit following permanent discontinuation of study drugs. For signs/symptoms, participants in follow-up at 96 wks (+12) with no new grade >=3 AE censored at 96 wks. Participants LTF <96 wks censored at LTF.||Percent of participants|||Number
175244|NCT00080119|Secondary|Time From Randomization to Death Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Deaths from any cause were included. Results report percent of participants dying by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to death was calculated. Participants LTF <96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks (+12 wks) censored at 96 weeks. HIVpos on study when study was discontinued were censored at their discontinuation visit.||Percent of participants|||Number
175245|NCT00080119|Secondary|Time From Randomization to Development of TB Infection Among HIV-infected and Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to development of TB infection was calculated. Participants LTF <96 weeks (+12 wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB infection were censored at 96 wks. HIVpos on study when study discontinued censored at their discontinuation visit.||Percent of participants|||Number
175246|NCT00080119|Secondary|Time From Randomization to Development of TB Disease Among HIV Infected and Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB disease were: Definite-isolation of M.tb or positive stain on CSF; Probable-positive AFB stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of PTB and either a +ve TST or minimum score on algorithm to diagnose clinical TB. All records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB disease. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes all starting study treatment. Time from randomization to development of TB disease was calculated. Participants LTF <96 wks (+12 wks) censored at time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. HIVpos on study when study discontinued were censored at their discontinuation visit.||Percent of participants|||Number
175247|NCT00080119|Secondary|Time From Randomization to Development of TB Disease or Death Among Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB disease were: Definite-isolation of M.tb or positive stain on CSF; Probable-positive AFB stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of PTB and either a +ve TST or minimum score on algorithm to diagnose clinical TB. All records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB disease. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVneg who started study treatment. Time from randomization to the first of TB disease/death was calculated. Participants lost-to-follow-up before 96 weeks (+12 week window)were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks who were free of TB disease were censored at 96 weeks (+12 week window).||Percent of participants|||Number
175248|NCT00080119|Secondary|Time From Randomization to HIV Disease Progression or Death Among HIV-infected Children|HIV disease progression was defined as any advancement in Centers for Disease Control (CDC) disease category from entry or death. If a participant was CDC disease category C at entry progression was defined as death. Results report percent of participants with HIV progression or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVpos starting study treatment. Time from randomization to first of disease progression/death calculated. Censored if LTF <96 wks, at 96 wks (if on study) or at discontinuation visit. Participants found to be HIVneg upon repeat testing could only progress by meeting a death endpoint.||Percent of participants|||Number
175249|NCT00080119|Secondary|Time From Randomization to Development of TB Infection or Death Among HIV-infected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive TST based on a PPD performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|HIVpos starting study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants LTF <96 weeks (+12 wk) censored at the time LTF. Participants in follow-up at 96 wks free of TB infection censored at 96 wks. Participants on study when study discontinued were censored at discontinuation visit.||Percent of participants|||Number
175250|NCT00080119|Primary|Time From Randomization to Development of TB Infection or Death Among Perinatally Exposed, HIV-uninfected Children|Criteria for diagnosis with TB infection were outlined in the protocol. TB infection included TB disease (see primary outcome measure 1 for definition) and latent TB infection. Latent TB infection was diagnosed by a positive tuberculin skin test (TST) based on a purified protein derivative (PPD) performed at week 96. Participant records were reviewed by an Endpoint Review Group to verify that participants had met the criteria for TB infection. Results report percent of participants reaching TB infection or death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|HIVneg who started study treatment were included. Time from randomization to first of TB infection/death was calculated. Participants lost-to-follow-up before 96 wks were censored at the time of loss-to-follow-up. Participants in follow-up at 96 weeks (+12 week window) who were free of TB infection were censored at 96 weeks (+12 week window).||Percent of participants|||Number
175259|NCT00079781|Primary|Short-term Chronic SAE Rate|"The RNS® System Short-term Chronic SAE rate = the percentage of implanted subjects having a serious adverse event (SAE) for the surgical implant procedure and the following 3 months (84 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Short-term Chronic SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the historical short-term chronic SAE rate for deep brain stimulation for movement disorders from the published literature (rate = 36%; upper CI = 46%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.~The primary safety outcome measure was met."|Initial implant through 3 months post-implant|||percentage of participants||95% Confidence Interval|Number
175251|NCT00080119|Primary|Time to Development of Tuberculosis (TB) Disease or Death Among HIV-infected Children|Criteria for diagnosis with TB disease: Definite-isolation of Mycobacterium TB (M.tb) or +ve stain on cerebrospinal fluid (CSF); Probable- +ve acid fast bacilli (AFB) stain on fluids/tissues other than CSF and sufficient clinical criteria/radiographic evidence suggestive of TB; Possible-abnormal chest radiograph suggestive of pulmonary TB (PTB) and either a +ve tuberculin skin test (TST) or minimum score on algorithm for clinical TB. Records reviewed by Endpoint Review Group. Results report percent of participants reaching TB disease/death by week 96 calculated using the Kaplan-Meier method.|Through to week 96|Includes HIVpos who started study treatment. Time from randomization to TB disease/death was calculated. Participants lost-to-follow-up (LTF) <96 wks (+12wks) censored at the time of LTF. Participants in follow-up at 96 wks free of TB disease censored at 96 wks. Participants on study when study discontinued censored at discontinuation visit.||Percent of participants|||Number
175252|NCT00079937|Primary|Percentage of Participants With at Least 1 Adverse Event|See Adverse Events module for details.|Baseline to end of the study (Week 68)|Safety population: All patients who received any study drug and had at least 1 post-baseline safety assessment.||Percentage of participants|||Number
175253|NCT00079937|Secondary|Change in Pediatric Asthma Quality of Life Questionnaire (Standardized) [PAQLQ(S)] Scores From Baseline to the End of the 24-week Fixed-dose Steroid Treatment Period (Week 24)|PAQLQ measures functional problems that are most troublesome to children with asthma. PAQLQ has 23 questions in 3 domains (activity limitation=5, emotional function=8, symptoms=10). Patients responded to each question on a 7-point Likert scale. Overall PAQLQ score is mean of 23 questions; each domain score is mean of questions in that domain. Minimum possible value is 1 (maximum impairment); maximum possible value is 7 (no impairment). Positive change indicated improvement. The analysis included country, baseline PAQLQ value, and dosing schedule (2-weekly/4-weekly) as factors and covariates.|Baseline to the end of the 24-week fixed-dose steroid treatment period (Week 24)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.||Units on a scale||95% Confidence Interval|Least Squares Mean
175254|NCT00079937|Secondary|Change in Mean Daily Number of Puffs of Asthma Rescue Medication From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period|Patients were instructed to record the number of puffs of rescue medication they took twice daily in a diary. The mean daily number of puffs during the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean daily number of puffs indicated reduced use of rescue medication.|Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.||Puffs||Standard Deviation|Mean
175255|NCT00079937|Secondary|Rate of Clinically Significant Asthma Exacerbations Per Patient in the 52-week Treatment Period|A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient's person-days at risk was taken as the total amount of time (in days) he/she spent in the 52-week treatment period.|Baseline to end of the treatment period (Week 52)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.||Exacerbations per patient per year||95% Confidence Interval|Mean
175256|NCT00079937|Primary|Rate of Clinically Significant Asthma Exacerbations Per Patient in the 24-week Fixed-dose Steroid Treatment Period|A clinically significant asthma exacerbation was defined as a worsening of asthma symptoms, as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose and/or treatment with systemic rescue corticosteroids for at least 3 days. The exacerbations rate per patient was derived using Poisson model adjusted by time at risk and the following covariates: country, exacerbation history, and dose schedule. A patient’s person-days at risk was taken as the total amount of time (in days) he/she spent in the 24-week fixed-dose steroid treatment period.|Baseline to end of the fixed-dose steroid treatment period (Week 24)|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.||Exacerbations per patient per 24-weeks||95% Confidence Interval|Mean
175257|NCT00079937|Secondary|Change in Mean Nocturnal Asthma Symptom Score From Baseline to the End (Last 4 Weeks) of the 24-week Fixed-dose Steroid Treatment Period|Nocturnal asthma symptom was measured daily on a scale of 0 to 4 in response to the question “How did you sleep last night?”, with 0 as the best response and 4 as the worst response. The mean of the last 4 weeks of the 24-week fixed-dose steroid treatment period was calculated; for patients who discontinued prematurely, the mean of the last 28 days before discontinuation was calculated. A negative change in mean score indicated improvement.|Baseline to the end (last 4 weeks) of the 24-week fixed-dose steroid treatment period|Modified intent-to-treat population: All patients who were randomized, excluding patients from 2 sites due to Good Clinical Practice non-compliance. Excluded patients were replaced with patients at other sites to maintain statistical power.||Units on a scale||Standard Deviation|Mean
175258|NCT00079781|Primary|Responder Rate|"Percentage of subjects with a 50% or greater reduction in mean seizure frequency during the post-implant Evaluation Period (4 months or 112 days) compared to pre-implant baseline (collected during the Prospective Seizure Frequency study). The primary effectiveness endpoint would be met with an observed responder rate of 13% or more.~The effectiveness endpoint was only calculated for the Treatment Population. The endpoint was used to support a Pivotal Study, not to demonstrate efficacy when compared to a control/sham group.~The primary effectiveness endpoint was met."|Pre-implant baseline through 4 months post-implant|||Percent of participants|||Number
175302|NCT00078728|Primary|Child Anxiety Diagnosis|Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.|12 month||01/2009||||
175260|NCT00079781|Primary|Acute SAE Rate|"RNS® System Acute SAE Rate = the percentage of subjects having a serious adverse event (SAE) for the surgical implant procedure and the following month (28 days), whether reported as device-related or not.~This outcome measure is met when the upper limit of the one-sided 95% confidence interval of the observed RNS® System Acute SAE Rate does not exceed the upper limit of the one-sided 95% confidence interval of the literature-based acute SAE rate associated with the implantation of intracranial electrodes for localization procedures and epilepsy surgery combined as documented in the literature (rate = 19%; upper CI = 28%). The comparator was calculated based upon the literature, therefore the number of participants analyzed is unknown/not applicable.~The primary safety outcome measure was met."|Initial implant through 1 month post-implant|||percentage of participants||95% Confidence Interval|Number
175261|NCT00079677|Primary|Number of Participants Who Had at Least Minimal Improvement in CGI-C Ratings at Week 12 or Last Post-baseline Visit.|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|12 weeks or last post-baseline visit|"Safety Analysis set of 259 total patients: 4 participants withdrew after randomization but prior to receiving study drug.~Full Analysis set of 236 total patients: 23 patients that had withdrawn from the study were non-evaluable for efficacy."||Participants|||Number
175262|NCT00079677|Primary|Maintenance of Wakefulness Test (MWT)|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).|Change from baseline at 12 weeks or early termination|"Safety Analysis set of 259 total patients: 4 participants withdrew after randomization but prior to receiving study drug.~Full Analysis set of 236 total patients: 23 patients that had withdrawn from the study were non-evaluable for efficacy."||Minutes||Standard Deviation|Mean
175263|NCT00079417|Secondary|Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0||From the beginning of treatment, assessed up to 10 years||||||
175264|NCT00079417|Secondary|Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level|EFSR will be estimated for patients who respond to vincristine and carboplatin after an initial 1 cycle of chemoreduction|Up to 10 years||||||
175265|NCT00079417|Secondary|Response Rate (RR) at Patient and Eye Levels After the First Course|RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy.|Up to 10 years||||||
175266|NCT00079417|Secondary|Use of Nonprotocol Chemotherapy|Use of nonprotocol chemotherapy at the patient level and enucleation and EBRT will be descriptively summarized at the patient and eye levels.|Up to 10 years||||||
175267|NCT00079417|Primary|Event-free Survival|Proportion of patients with event free survival at 2 years. An event is defined as the need for non-protocol therapy, defined as additional on-protocol chemotherapy, enucleation or external beam radiation, among patients with Group B intraocular tumors with a schedule of neoadjuvant 2-agent (Vincristine/Carboplatin) chemotherapy (chemo-reduction) and standardized local ophthalmic therapy.|At 2 years|One patient was ineligible and was not included in the analysis.||Proportion||95% Confidence Interval|Number
175268|NCT00079391|Secondary|Acute GVHD Overall|Incidence of acute GVHD grades II-IV (before and after T cell add back) Modified Glucksberg grading|First 100 days|||participants|||Number
175269|NCT00079391|Secondary|Acute Graft Versus Host Disease (Before Day 60 T Cell Add Back)|"Incidence of acute Graft versus host disease (GVHD) grades II-IV (before day 60 T cell add back)~Modified Glucksberg grading"|First 60 days|Per protocol||participants|||Number
175270|NCT00079391|Secondary|Cumulative Incidence of Relapse|Kaplan Meier-estimate of relapse incidence|at 5 years post transplant|||percentage of participants|||Number
175271|NCT00079391|Secondary|Non Relapse Mortality.|"Non relapse mortality: death without relapse~Kaplan Meier estimate"|at 5 years post transplant|||percentage of participants|||Number
175272|NCT00079391|Secondary|Overall Survival|Kaplan Meier estimate of survival|at 5 years post transplant|||percentage of participants|||Number
175273|NCT00079391|Primary|The Proportion of Patients Who Develop Full Donor T Cell Chimerism at Day 30|"The proportion of patients who develop full donor CD3+ lymphocyte chimerism by day 30.~Full chimerism is defined as >95% donor alleles by molecular profiling (Short Tandem Repeat analysis)."|Day 30|Per protocol; only patients who survived to day 30 and were evaluable.||percentage of participants|||Number
175274|NCT00079339|Secondary|Mean Tumor to White Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal white matter to provide ratios of tumor/white matter. Each patient has a mean tumor to white matter ratio value and the median of these values across patients is reported.|Baseline|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan.||Ratio||Full Range|Median
175303|NCT00078715|Secondary|To Determine Whether Measures Previously Demonstrated to be Predictive of Response to Sleep Deprivation & Noradrenergically Mediated Will be Assoc With Response to Yohimbine When Administered During REM Sleep.||2-4 weeks||||||
175304|NCT00078715|Primary|Hamilton Depression Rating Scale (6 Items)|The 6 item Hamilton Depression Rating Scale is a measurement of the severity of depression with a range of scores from 0 to 24, where 24 indicates the most severe depression.|Once per day, where the primary comparison involves an average over the full study after controlling for baseline|||Units on a scale||Standard Error|Mean
175275|NCT00079339|Secondary|Mean Tumor to Gray Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal gray matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to gray matter ratio value and the median of these values across patients is reported.|Baseline|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline PET scan.||Ratio||Full Range|Median
175276|NCT00079339|Secondary|Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response, survival, etc.). Volume FLAIR is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain. Volume FLAIR was obtained at baseline and within two weeks after completion of radiation.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline volume FLAIR value and a second volume FLAIR value measured at approximately 8 weeks after starting treatment.||cubic centimeters||Full Range|Median
175277|NCT00079339|Secondary|Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation.|This study attempted to investigate in an exploratory manner the effect of treatment on changes in neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Diffusion values are obtained from magnetic resonance diffusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline diffusion ratio value and a second diffusion ratio value measured at approximately 8 weeks after starting treatment.||Ratio||Full Range|Median
175278|NCT00079339|Secondary|Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in neuroimaging meaurements. Neuroimaging changes may have some association with outcome (response, survival, etc.). Perfusion values are obtained from magnetic resonance perfusion imaging and were measured at baseline, every 8 weeks for the first 48 weeks, and then every 12 weeks until treatment is discontinued.|Baseline and two weeks post completion of radiation|The analysis population consists of participants, from both the phase I part and the phase II part, treated at any dose level who had a baseline perfusion ratio value and a second perfusion ratio value measured at approximately 8 weeks after starting treatment.||Ratio||Full Range|Median
175279|NCT00079339|Primary|Progression-free Survival (PFS)|PFS was defined as the interval from initiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurological status) or death for patients who failed, or to the last date of follow up for patients without failure.|Assessed before the first dose of tipifarnib, every 8 weeks for the first 48 weeks, and then every 12 weeks.|Per protocol 40 participants who received at least one dose of tipifarnib were needed for this objective. The analysis population consists of phase I participants treated at the maximum tolerated dose (MTD) and the participants enrolled to the phase II part.||Months||Full Range|Median
175280|NCT00079339|Primary|Number of Participants in the Phase I Component With Dose-limiting Toxicities (DLTs) Observed During the First 8 Weeks (Courses 1 and 2) of Tipifarnib Therapy|The dose limiting toxicity (DLT) analysis population consists of phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD.|Day 1 of tipifarnib therapy to week 8|Per protocol, participants included phase I participants who developed dose-limiting toxicities during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without dose-limiting toxicities.||Participants|||Number
175281|NCT00079326|Secondary|Time to Treatment Failure (TTF)|Time to Treatment Failure as determined by RECIST v.1.0 Criteria: is the time from the date of randomization or start of treatment to the earliest date of progression, date of death due to any cause, or date of discontinuation due to reasons of adverse events, abnormal laboratory values, abnormal test procedure results, subject withdraws consent, or date 'Lost to follow up'.|up to 6 years|||months||95% Confidence Interval|Median
175282|NCT00079326|Primary|Overall Response Rate|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography or magnetic resonance imaging scans: Complete response (CR) is defined as the disappearance of all target lesions; Partial Response is defined by at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response Rate (ORR) = CR + PR.|Up to 6 years|||percentage of participants||95% Confidence Interval|Number
175283|NCT00079274|Secondary|Toxicity|Number of grade 3+, grade 4, and grade 5 adverse events. Based on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0|Assessed up to 8 years||||||
175284|NCT00079274|Secondary|Overall Survival|The time from randomization until death. Estimated by the method of Kaplan and Meier.|Up to 8 years||01/2018||||
175285|NCT00079274|Secondary|Disease-free Survival|The time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier.|Up to 5 years||||||
175305|NCT00078559|Secondary|Change in Renal Function as Measured by Serum Creatinine, Stratified by Withdrawal Status|Mean change from transplantation to Month 48 in serum creatinine. Normal serum creatinine range is from 0.7 – 1.4 mg/dL. In a transplant population, starting serum creatinine is higher than normal range. A negative change indicates better renal function|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||mg/dL||Standard Deviation|Mean
175306|NCT00078559|Secondary|Number of Side Effects of Conventional Immunosuppression, Stratified by Withdrawal Status|Side effects of conventional immunosuppression include increased body weight and hypertension|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||side effects|||Number
175286|NCT00079274|Secondary|Disease-free Survival (Arms A and D: Mutant KRAS Patients)|"A secondary endpoint for this study was to investigate the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS mutant (or KRAS-nonevaluable) and randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint.~Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier."|At 3 years|The analysis was performed using intention to treat principles. All patients that were KRAS mutant (or not evaluable for KRAS) and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.||percentage of participants||95% Confidence Interval|Number
175287|NCT00079274|Primary|Disease-free Survival (Arms A and D: Wild-type KRAS Patients)|"The primary endpoint for this study was to compare the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint.~Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first. Estimated by the method of Kaplan and Meier."|At 3 years|The analysis was performed using intention to treat principles. All patients that were wild-type KRAS and received randomized treatment according to the Arm A or Arm D intervention schedule were evaluated for this endpoint. Any patient receiving irinotecan was not included in the evaluation of this endpoint.||percentage of participants||95% Confidence Interval|Number
175288|NCT00079040|Secondary|Best Objective Response|Number of patients with complete or partial response by RECIST criteria.|Assessed every 6 weeks|Per protocol, the analysis included all eligible, treated patients.||Patients Responding|||Number
175289|NCT00079040|Secondary|Overall Survival|Overall survival is defined as the time from registration to death or date last known alive. Patients alive at last follow-up are censored.|Assessed every 3 months for 2 years, then every 6 months for 1 year|Per protocol, the analysis included all eligible, treated patients||months||95% Confidence Interval|Median
175290|NCT00079040|Primary|Percentage of Participants Alive and Progression-free (PF) at 6 Months|Progression-free survival was defined to be the interval in months from the date of registration to the date of documented disease progression or to death without progression. Patients alive without progression at 6 months were included in the numerator when calculating the progression-free rate.|6 months|Per protocol, the analysis included all eligible, treated patients (n=63). The safety analysis included all treated patients, regardless of eligibility (n=64).||Percentage of Participants||95% Confidence Interval|Mean
175291|NCT00079001|Secondary|Progression-free Survival|"Progression Free Survival (PFS) was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method.~Progression is defined as one or more of the following: new bone metastases, biochemical progression of PSA, treatment with radiation therapy while on treatment."|Up to 10 years|||months||95% Confidence Interval|Median
175292|NCT00079001|Secondary|Overall Survival|Overall survival (OS) was defined as the time from randomization to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% CI was estimated using the Kaplan Meier method.|Up to 10 years|||months||95% Confidence Interval|Median
175293|NCT00079001|Primary|Time to First Skeletal Related Event|Time to first skeletal related event (SRE) was defined as the time from randomization to first skeletal event. Skeletal events are defined as radiation to bone, clinical fracture, surgery to bone and spinal cord compression and death due to prostate cancer. The median with 95% CI was estimated using the Kaplan Meier method.|Up to 10 years|||months||95% Confidence Interval|Median
175294|NCT00078949|Secondary|Toxicity Assessed by NCI CTC v2.0 for 2 Years in Patients on Treatment Arm II||10 years||||||
175295|NCT00078949|Secondary|Mobilization Rate of Patients on Treatment Arm I Assessed by CD34 Count After 2 Courses of Therapy and Stem Cell Harvesting||10 years||||||
175296|NCT00078949|Primary|Event-free Survival of Patients on Maintenance Randomization (Period 2)|Number of patients who develop EFS event during maintenance randomization (period 2)|during the period 2 (up to10 years)|ITT population||participants|||Number
175297|NCT00078949|Primary|Transplantation Rate of Patients After 2 Courses of Chemotherapy|Transplantation rate is defined as the number of patients who respond sufficiently to protocol salvage chemotherapy to be planned for transplantation minus those who do not meet the endpoint of successful transplantation, divided by the number of all randomized patients|During period 1 (salvage chemotherapy)|||percentage of transplantation|||Number
175298|NCT00078949|Primary|Response Rate of Patients After 2 Courses of Chemotherapy|The overall response rate by arm is calculated as total number of responders (CR + CRu + PR) / (all patients in the ITT analysis population).|After 2 cycle of treatment|ITT population||percentage of response|||Number
175299|NCT00078754|Secondary|Treatment Response, Assessed as a Function of the Severity of Lifetime Aggressiveness of the Participant and as a Function of the Pretreatment Status of the Central 5-HT Receptor System||Measured at Week 12||||||
175300|NCT00078754|Primary|Overt Aggression Scale-Modified (OAS-M)|OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week.|Measured at Week 12|||units on a scale||Standard Error|Mean
175301|NCT00078728|Primary|Child Anxiety Diagnoses|The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.|12 months|||participants|||Number
175310|NCT00078559|Secondary|Number of Participants Requiring Anti-lymphocyte Therapy for an Acute Rejection, Stratified by Sirolimus Withdrawal Status|"Participants who experienced acute rejection[1] during study which required anti-lymphocyte (OKT3, ATG) therapy~1] Acute rejection is defined as a biopsy-prove rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to four years post-transplantation)|Intent-to-treat||participants|||Number
175311|NCT00078559|Secondary|Number of Severe Acute Rejections Stratified by Sirolimus Withdrawal Status|"Participants who experienced severe acute rejections[1] during study~Severe acute rejection is defined as that which requires treatment with anti-lymphocyte antibody or is histologically evaluated as Type IIA or greater using the Banff 1997 criteria[2]~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to severe acute rejection (up to four years post-transplantation)|Intent-to-treat||Rejection Events|||Number
175312|NCT00078559|Secondary|Number of Participants Who Experienced Graft Loss Stratified by Sirolimus Withdrawal Status|"Participants who experienced graft loss[1] during study~[1]Graft loss is defined as the institution of chronic dialysis (at least 6 consecutive weeks, excluding participants with delayed graft function), transplant nephrectomy, or retransplantation"|Transplantation to Graft Loss (up to four years post-transplantation)|Intent-to-treat||participants|||Number
175313|NCT00078559|Secondary|Number of Deaths Stratified by Sirolimus Withdrawal Status|Participants who died during the study, all cause(s)|Transplantation to Death (up to four years post-transplant)|Intent-to-treat||deaths|||Number
175314|NCT00078559|Secondary|Time From Transplantation to Acute Rejection in Participants for Whom Acute Rejection Occurred During the 1 Year Post-transplant Period|"Time (days) to acute rejection[1] for participants occurring during the year following transplantation~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to one year post-transplant)|Participants with acute rejections for whom sirolimus withdrawal was not initiated||Days|||Number
175315|NCT00078559|Secondary|Time From Transplantation to Acute Rejection in Participants for Whom Sirolimus Withdrawal Was Not Initiated|"Time (days) to acute rejection[1] for participants where sirolimus was not initiated~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to acute rejection (up to four years post-transplantation)|Participants for whom sirolimus withdrawal was not initiated||Days|||Number
175316|NCT00078559|Secondary|Number of Acute Rejections Between Initiation of Sirolimus Withdrawal and End of Study|"Acute rejections[1] between initiation of sirolimus withdrawal and end of study~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Initiation of sirolimus to end of study (up to four years post-transplant)|Sirolimus withdrawal initiation participant sample||Rejection Events|||Number
175317|NCT00078559|Secondary|Number of Acute Rejections in All Enrolled Participants Following Sirolimus Withdrawal|"Following sirolimus withdrawal, the number of acute rejections[1] in all enrolled participants~1] Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~[2] Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Transplantation to end of study (up to four years post-transplant)|Intent-to-treat||Rejection Events|||Number
175318|NCT00078559|Primary|Number of Acute Rejections in All Enrolled Participants|"Number of acute rejections[1] in all enrolled subjects from the time of transplantation to the end of the trial (four years post-transplant)~Acute rejection is defined as a biopsy-proven rejection: a renal biopsy demonstrates acute cellular or humoral rejection of Banff[2] Grade 1B or greater; or presumed rejection in the absence of biopsy-proven rejection, the participant is treated for an unexplained 20% increase in serum creatinine.~Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713-723, 1999"|Four years post-transplant|Intent-to-treat||Rejection Events|||Number
175319|NCT00078403|Secondary|Weight|Participant weight in kilograms.|Arms A and B: at entry and weeks 4, 8, 12, 16, 24, 32, 40, 48, 56, 64 and 72; Arm C: at entry and weeks 4, 8, 12, 16, 24, 36, 48, 72, 84 and 96.|All Arm A, B and C participants who had weight available. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.||kilograms||Inter-Quartile Range|Median
175320|NCT00078403|Secondary|Number of Participants With Prescription as Needed of Erythropoietin (EPO), Granulocyte Colony-stimulating Factor (GCSF), and Granulocyte-monocyte Colony-stimulating Factor (GM-CSF)|Prescription as needed of hematologic adjuvant therapies: erythropoietin (EPO), granulocyte colony-stimulating factor (GCSF), and granulocyte-monocyte colony-stimulating factor (GM-CSF) any time after pre-assignment|At any time after pre-assignment|All Arm A, B and C participants||Participant|||Number
175321|NCT00078403|Secondary|Number of Participants Who Used Antianorexia Agents, Such as Megestrol and Dronabinol|Use of antianorexia agents, such as megestrol and dronabinol at any time after pre-assignment.|Up to 96 weeks|All Arm A, B and C participants||Participant|||Number
175322|NCT00078403|Secondary|Sustained Virologic Response|Sustained Virologic Response (SVR) was defined as undetectable HCV viral load (<60 IU/ml) 24 weeks after treatment discontinuation.|24 weeks after end of treatment|All Arm A, B and C participants||Participant|||Number
175323|NCT00078403|Secondary|Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)|Insulin resistance was evaluated by HOMA-IR, calculated as [fasting glucose (mg/dL) x fasting insulin (uIU/mL)]/405. Study protocol required fasting for at least 8 hours (nothing by mouth except medications and water) prior to specimen collection for fasting insulin and fasting glucose testing.|Arms A and B: at entry and weeks 24, 48 and 72; Arm C: at entry and at weeks 12, 24, 36, 48, 72, 84 and 96.|All Arm A, B and C participants who had HOMA-IR result available. In Arm C, metabolic testing was only performed on participants who enrolled under protocol version 1.0. The number of participants with results available at time points listed in the Time Frame are shown in the Data Table Row Titles below.||mg/dL x uIU/mL||Inter-Quartile Range|Median
175324|NCT00078403|Secondary|Number of Participants With Undetectable HIV Viral Load (<50 Copies/mL)|A blood sample was drawn to determine the HIV-1 viral load. HIV-1 viral load was categorized as <50 copies/mL (undetectable) or >=50 copies/mL (detectable). 50 is the lower limit of detection of the assay.|Arms A and B: Weeks 0, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 48, 60, 72, 84|All Arm A, B, and C participants||Participant|||Number
175325|NCT00078403|Secondary|HCV-specific Immune Response in Intrahepatic Lymphocytes|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.|Entry and week 72 (Arms A and B only).|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.|||||
175326|NCT00078403|Secondary|HCV Polymorphisms|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued.|Entry and week 72 (Arms A and B only).|Due to premature closure of Arms A and B with insufficient number of participants for analysis, this outcome measure was not pursued. No participants were analyzed.|||||
175327|NCT00078403|Secondary|Number of Participants Adherent to Study Medications|A categorical variable with levels adherent and non-adherent based on participants' self report. For Arm A, adherence was defined as not missing PEG within 2 weeks of visit. For Arm C, adherence was defined as not missing any PEG within 2 weeks of visit and not missing RBV within 4 days of visit.|Arm A: at weeks 12, 24, 48 and 72. Arm C: at entry and weeks 12, 24, 48, 60.|All Arm A and Arm C participants. Arm B participants did not receive treatment.||Participant|||Number
175328|NCT00078403|Secondary|Number of Participants With Dose Modifications, Temporary Stops, and Premature Treatment Discontinuations|3-level categorical of the worst of 1) premature treatment discontinuation, 2) temporary stop or 3) dose reduction. For Arm C, the worst for either PEG-IFN or RBV is summarized.|Up to 96 Weeks|All Arm A and C participants. Arm B participants did not receive treatment.||Participant|||Number
175329|NCT00078403|Secondary|Number of Participants With High-grade Signs and Symptoms or Laboratory Values|Number of participants with high-grade (Grade 3 or higher) signs and symptoms or laboratory values. DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = transient/mild discomfort, no limitation in activity, no medical intervention; Grade 2 = mild/moderate limitation in activity, some assistance, no/minimal medical intervention; Grade 3 = marked limitation in activity, some assistance, medical intervention required); Grade 4 = extreme limitation in activity, significant medical intervention, assistance, hospitalization.|Up to 96 Weeks|All Arm A, B and C participants||Participant|||Number
175330|NCT00078403|Secondary|Number of Participants With Depression and/or Other Psychological Events|Depression and other psychological events. DAIDS Toxicity Grading Table (1992) was used for grading. The protocol required reporting of depression and other psychological events of Grade 3 or higher or if led to a change in treatment, regardless of grade.|Up to 96 weeks|All Arm A, B and C participants||Participant|||Number
175331|NCT00078403|Secondary|Number of Participants With Thrombocytopenia|Number of participants with thrombocytopenia by grade (defined by platelet count per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = platelets of 75,000 to 99,000 /mm^3; Grade 2 = 50,000 to 74,999 /mm^3; Grade 3 = 20,000 to 49,999 /mm^3; Grade 4 = below 20,000 /mm^3.|Up to 96 weeks|All Arm A, B and C participants||Participant|||Number
175332|NCT00078403|Secondary|Number of Participants With Neutropenia|Number of participants with neutropenia by grade (defined by absolute neutrophil count [ANC] per cubic millimeter; mm^3). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = ANC of 1000 to 1500 /mm^3; Grade 2 = 750 to 999 /mm^3; Grade 3 = 500 to 749 /mm^3; Grade 4 = below 500 /mm^3.|Up to 96 weeks|All Arm A, B and C participants||Participant|||Number
175333|NCT00078403|Secondary|Number of Participants With Anemia|Number of participants with anemia by grade (defined by hemoglobin level in grams per deciliter; g/dL). DAIDS Toxicity Grading Table (1992) was used for grading where Grade 1 = hemoglobin of 8 to 9.4 g/dl; Grade 2 = 7 to 7.9 g/dl; Grade 3 = 6.5 to 6.9 g/dl; Grade 4 = below 6.5 g/dl.|Up to 96 weeks|All Arm A, B and C participants||Participant|||Number
175334|NCT00078403|Secondary|Time-scaled Change in Ishak Liver Inflammation Score (SCIIS)|Liver biopsies were performed within 42 days prior to randomization between Arms A and B while the participant remained on PEG-IFN plus RBV (=entry biopsy) and again at week 72 or premature study discontinuation (=exit biopsy). SCIIS was defined as the difference between the Ishak inflammation score of the exit biopsy and the Ishak inflammation score of the entry biopsy, where the difference is scaled to one year.|Baseline and at week 72 or premature discontinuation|All participants with SCIIS available (Complete Cases)||Ishak units per one year (52 weeks)||Inter-Quartile Range|Median
175335|NCT00078403|Secondary|Number of Participants With Detectable HCV Viral Load (>= 60 IU/mL)|Qualitative plasma HCV viral load was categorized as less than 60 IU/mL vs greater than or equal to 60 IU/mL where 60 IU/mL is the lower limit of qualitative assay used in Steps 2 and 3.|Arms A and B: Weeks 0, 12, 24, 48 and 72; Arm C: Weeks 0, 12, 24, 36, 60, 72, 84|All Arm A, B and C participants||Participant|||Number
175336|NCT00078403|Primary|Time-scaled Change in Metavir Liver Fibrosis Score (SCMFS)|SCMFS is the difference between the Metavir fibrosis scores of the study exit and study entry liver biopsies where the difference is scaled to one year. The SCMFS assesses the annualized change in the severity of liver fibrosis on a continuous scale from -4.0 Metavir units per year (reduced fibrosis over time, a positive study outcome) to +4.0 Metavir units per year (increased fibrosis over time).|Baseline and at week 72 or premature discontinuation|62 Arm A and B participants who had follow-up liver biopsy performed or those who had Week 72 potential as of May 2, 2007 but no follow-up liver biopsy. In the unadjusted ITT analysis, the participants without SCMFS available were assigned the highest SCMFS (+2).||Metavir units per one year (52 weeks)||Inter-Quartile Range|Median
175337|NCT00078377|Primary|Change From Baseline in Clinical Global Impression of Change (CGI-C) Score at 12 Weeks|Number of participants who had at least minimal improvement in CGI-C ratings at Week 12 or last post-baseline visit. The CGI-C uses the following categories and scoring assignments: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness was assessed at baseline by the CGI-S, which consists of the following categories: 1=Normal (shows no signs of illness); 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|change from baseline at 12 weeks|"Safety Analysis set of 194 total patients (received at least 1 dose of study drug): 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up).~Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy analysis."||Participants|||Number
175338|NCT00078377|Primary|Change From Baseline in Maintenance of Wakefullness Test (MWT) Score at 12 Weeks|The Maintenance of Wakefulness Test (MWT) is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. The change from baseline in the mean sleep latency from the MWT (average of 4 tests at 0900, 1100, 1300, and 1500) was analyzed at weeks 4, 8, and 12. The primary efficacy variable was the mean change from the baseline assessment in MWT sleep latency as assessed at week 12 (or last post-baseline visit).|change from baseline at 12 weeks|"Safety Analysis set of 194 total patients: 2 patients withdrew after randomization but prior to receiving study drug (1 withdrew consent and 1 was lost to follow-up).~Full Analysis set of 176 total patients: 18 patients that had withdrawn from the study were non-evaluable for efficacy."||Minutes||Standard Deviation|Mean
175339|NCT00078325|Primary|Clinical Global Impression of Change (CGI-C)|The CGI-C represents a subjective measure of the patient’s global health (clinician’s rating of disease severity as compared with a pretreatment evaluation as assessed by the CGI-S). The CGI-C scale (change from baseline)categories include:1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse. Severity of illness (CGI-S) was assessed at baseline includes categories: 1=Normal; 2=Borderline ill; 3=Mildly (Slightly) ill; 4=Moderately ill; 5=Markedly ill; 6=Severely ill; and 7=Among the most extremely ill patients.|change from baseline at 12 weeks|Safety Analysis set of 392 total patients (ITT): 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)||Participants|||Number
175340|NCT00078325|Primary|Maintenance of Wakefulness Test (MWT)|The MWT is an objective assessment of sleepiness that measures the ability of a subject to remain awake. Long latencies to sleep are indicative of a patient’s ability to remain awake. The primary variable was the 30 minute MWT (average of 4 naps at 0900, 1100, 1300, and 1500) assessed at the last postbaseline observation.|change from baseline at 12 weeks|"Safety Analysis set of 392 total patients: 3 patients withdrew after randomization but prior to receiving study drug (1 had a protocol violation and 2 were lost to follow-up)~Full Analysis set of 365 total patients: 27 patients that had withdrawn from the study were non-evaluable for efficacy."||Minutes||Standard Deviation|Mean
175341|NCT00078312|Primary|Safety and Tolerability as Measured by Number of Participants With Adverse Events|Serious and Non-serious Adverse Events (SAEs). Serious adverse event is any adverse event occurring at any dose that results in any of the following outcomes: death, life-threatening, inpatient hospitalization, persistent or significant disability, congenital anomaly, or an important medical event. An adverse event that does not meet any of the criteria for seriousness listed previously will be regarded as a nonserious adverse event.|Screening/Baseline and months 1, 3, 6, 9, and 12 and every 3 months thereafter|Safety Analysis set of 323 total patients: 5 participants withdrew after enrollment but prior to receiving study drug (1 withdrew consent, 3 were lost to follow-up, and 1 was noncompliant)||Participants|||Number
175342|NCT00078286|Secondary|Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.|Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups.|Measured at Week 12|Analysis was based on intent to treat (ITT).||percentage of participants|||Number
175343|NCT00078286|Primary|Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo|"Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo.~The 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period."|Measured at Week 12|Analysis was based on intent to treat (ITT), using random coefficient modeling.||HDRS Change Score||Standard Deviation|Mean
175344|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
175345|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662). Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
175451|NCT00076804|Primary|Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 24 Months of Treatment|Proportion of Patients with HIV RNA Levels of <400 Copies/mL at 24 Months [Intention-to-treat (ITT)|24 months|||participants|||Number
175346|NCT00077974|Secondary|Dose Corrected Plasma Trough Concentrations of Sunitinib|Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib. Dose—corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
175347|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite|Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
175348|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib Metabolite|Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
175349|NCT00077974|Secondary|Observed Plasma Trough Concentrations of Sunitinib|Observed plasma trough (predose) (Cmin) concentrations of sunitinib|Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater|Pharmacokinetic analysis population||nanograms per milliliter||Standard Deviation|Mean
175350|NCT00077974|Secondary|Percent Chance of Patient Survival|Probability of survival 1 year and 2 years after the first dose of study treatment|From start of study treatment until death|ITT||percent chance of survival|||Number
175351|NCT00077974|Secondary|Progression-free Survival (PFS)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was “Death”).|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death|ITT||weeks||95% Confidence Interval|Median
175352|NCT00077974|Secondary|Overall Survival (OS)|Time in weeks from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).|From start of study treatment until death|ITT||weeks||95% Confidence Interval|Median
175353|NCT00077974|Secondary|Duration of Response (DR)|"Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.~DR was calculated for the subgroup of patients with a confirmed objective tumor response."|Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer|ITT subgroup of patients with a confirmed objective tumor response||weeks||95% Confidence Interval|Median
175354|NCT00077974|Secondary|Time to Tumor Progression (TTP)|Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter|ITT||weeks||95% Confidence Interval|Median
175355|NCT00077974|Primary|Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)|Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST. CR defined as disappearance of all target lesions. PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter|The intent-to-treat (ITT) population included all subjects who enrolled in the study that received at least 1 dose of study medication. This was the primary population for all efficacy analyses and safety analyses.||participants|||Number
175356|NCT00077922|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|54 months|||Participants|||Number
175357|NCT00077922|Primary|Response Rate|Response is measured by the 1996 National Cancer Institute (NCI) Working Group Criteria (NCIWG). Complete response is defined as no hepatomegaly, splenomegaly, or lymphadenopathy by physical examination and appropriate radiographic techniques. Lymph nodes must resolve to <1.0cm of 1-1.5cm at baseline, or <1.5cm if >1.5cm at baseline. Partial response is >=50% decrease in peripheral blood lymphocytes count from the pretreatment baseline value. Progressive disease is >=50% increase in the sum of the products of the greatest perpendicular dimensions of a t least 2 lymph nodes on two consecutive examinations 2 weeks apart (at least 1 node must be >=2cm) or appearance of new palpable lymph nodes. Stable disease is characterized by not meeting the above criteria. For additional details about the NCIWG, see the protocol link module.|Patients were followed for at least 30 days after last treatment. Because the study allows 6 treatment cycles, this can be up to 7 months.|||Participants|||Number
175358|NCT00077857|Secondary|Number of Participants With Adverse Events and Serious Adverse Events|"An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.~A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.~Additional information about Adverse Events can be found in the Adverse Event Section."|First study drug intake until last study drug intake plus 28 days|Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m^2 actual received an initial dose that ranged from 480 to 984 mg/m^2 so are included in the 825 mg/m^2 arm for safety.||Participants|||Number
175360|NCT00077857|Secondary|Time to Treatment Failure|"The time to treatment failure was the time from the date of randomization to the first occurrence of any of the following events:~adverse events~insufficient therapeutic response (disease progression)~death~failure to return~refusing treatment/being unwilling to cooperate~withdrawing consent."|Until premature withdrawal or end of primary study treatment (up to 16 cycles).|Safety Population included all randomized participants who received study drug. Note: 14 patients randomized to 1250 mg/m^2 actual received an initial dose that ranged from 480 to 984 mg/m^2 so are included in the 825 mg/m^2 arm for safety.||Months||95% Confidence Interval|Median
175361|NCT00077857|Secondary|Duration of Overall Response|Duration of overall response was measured from the time that measurement criteria were first met for Complete Response or Partial Response until the first date that progressive disease or death was documented.|Until PD or death. Median duration of response was approximately 7 months.|Intent to treat population included all randomized participants.||Months||95% Confidence Interval|Median
175362|NCT00077857|Secondary|Time to Overall Response|For patients with Best Overall Response being Complete Response (CR) or Partial Response (PR), time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR were met. The percentage of participants with overall response within the given time ranges in each of the categories: Weeks 1-6, 7-12, 13-18, 19-24, 25-30, 31-36, and 43-48 are reported.|Until PD or end of primary study treatment (up to 16 cycles) plus 28 days.|Intent to treat population included all randomized participants.||Percentage of participants|||Number
175363|NCT00077857|Secondary|Percentage of Participants With Best Overall Response Being Complete Response (CR) or Partial Response (PR)|According to Response Evaluation Criteria in Solid Tumors (RECIST) criteria: CR is defined as the disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the nadir sum LD.|Until Progressive Disease (PD) or end of primary study treatment (up to 16 cycles) plus 28 days.|Intent to treat population included all randomized participants.||Percentage of participants||95% Confidence Interval|Number
175364|NCT00077857|Primary|Time to Progression of Disease or Death|Progression Free Survival was defined as the time from the date of randomization to the day of documented disease progression or death due to any cause.|Event driven (after 350 events). Median observation time was approximately 16 months.|Per protocol population included all participants who received at least one dose of study and who did not have any major protocol deviations.||Months||95% Confidence Interval|Median
175365|NCT00077766|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Event, and Deaths|An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.|Up to Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not.||Participants|||Number
175366|NCT00077766|Secondary|Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52|Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline (BL) value and a value for specified time period.|Baseline, Week 36, and Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time point were included in the analysis (n).||beats per minute||Standard Deviation|Mean
175367|NCT00077766|Secondary|Mean Change in Blood Pressure From Baseline at Week 36 and Week 52|Blood pressure Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) was measured by manual assessment or automated reading throughout the study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic and diastolic blood pressures were recorded before dialysis (BD) and after dialysis (AD).|Baseline, Week 36, and Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time point were included in the analysis (n).||millimeters of mercury (mm Hg)||Standard Deviation|Mean
175368|NCT00077766|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0– 18.0 10^9/liter [L]), platelets (100 – 550 10^9/L), (alanine aminotransferase [(ALAT)] (0 – 110 units per liter [U/L]), alkaline phosphatase (ALP) (0 – 220 U/L), aspartate aminotransferase (ASAT) (0 – 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimole per liter [mmol/L]), potassium (2.9 – 5.8 mmol/L), glucose (2.80 – 11.10 mmol/L).|Up to Week 52|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Data from participants available at protocol specified assessment time points were included in the analysis (n).||Participants|||Number
175369|NCT00077766|Secondary|Number of Participants With Red Blood Cell Transfusions During the Dose Titration and Evaluation Periods|A combined data of the number of participants who received Red Blood Cell (RBC) transfusions during the titration and evaluation periods is reported. A period of 28 weeks after the first dose of the study drug was used for dose titration and stabilization of Hb concentration. The dose titration period was followed by an 8-week evaluation period (weeks 29 to 36).|Week 1 to Week 36|The safety population was defined as all participants who received at least one dose of RO0503821 or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not.||Participants|||Number
175452|NCT00076804|Primary|Impact of DOT Compared to Self-administered Treatment as Measured by HIV Viral Load at 12 Months of Treatment|Proportion of Patients with HIV RNA Levels of <400 at 12 Months - Intention-to-treat|at 12 and 24 months of treatment|||participants|||Number
175370|NCT00077766|Secondary|Number of Participants Maintaining Average Hemoglobin Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hemoglobin Concentration|The average Hb of all values recorded during the evaluation period was calculated, and this average was subtracted from the average baseline Hb values for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline Hb concentration is displayed. The evaluation period was defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)|The Intent-to-Treat (ITT) population was defined as all randomized participants. Participants with available data at the time of evaluation were analyzed.||Participants|||Number
175371|NCT00077766|Primary|Mean Change in Hemoglobin Concentration (g/dL) From Baseline to Evaluation Period|A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline (Week -4 to Week -1) and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. The analysis used the last observation carried forward (LOCF) for missing Hb values for correction of the impact of early drop outs. The baseline period was defined as Week -4 to Week -1. The evaluation period was defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation Period (Week 29 to Week 36)|The per protocol population was all randomized and treated participants, except those who had not met criteria for stable baseline Hb,and adequate iron levels or had hemoglobinopathies/hemolysis, RBC transfusion/blood loss, <5 recorded Hb values during evaluation or missed administrations of trial drugs in week 26 to 35.||gram per deciliter (g/dL)||Standard Deviation|Mean
175372|NCT00077675|Primary|Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|"Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.~Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to Test-of-Cure (TOC) visit~Indeterminate: Inability to determine outcome."|7 to 14 days following completion of antibiotic treatment|"The CE population was a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of cure or failure. The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population."||participants|||Number
175373|NCT00077649|Primary|Percentage of Participants With Predicted Sustained Virological Response|The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was <0.5. The percentage was calculated from the number of participant (N) analyzed under “Distribution of the predicted probability of an SVR.”|Week 4 and 12|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||percentage of participants|||Number
175374|NCT00077649|Primary|Percentage of Participants With Virological Response Over Time to Week 24|Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24.|72 hours post-dose, Weeks 1, 2, 4, 12, and 24|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||percentage of participants||95% Confidence Interval|Number
175375|NCT00077649|Secondary|Total BDI-II (Beck Depression Inventory) Scores|The BDI-II is a self-reported assessment of 21 items which included sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, loss of interest in sex that are summarized by treatment group. All except two items had four statements that were scored on a scale ranging from 0 to 3. The maximum total score was 63. The scores for each item were summed to obtain the total for that assessment. The participants neurological status could then be categorized as follows: minimal depression: 0 to 13; mild depression: 14 to 19; moderate depression: 20 to 28; and severe depression: 29 to 63. The BDI-II questionnaire was self-administered by the patient at each visit.|From Baseline (Day 1) to Week 72|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.||Units on a scale||Standard Deviation|Mean
175376|NCT00077649|Secondary|Percentage of Participants With Abnormal Vital Signs|Vital signs (Systolic blood pressure, Diastolic blood pressure, Pulse rate) were considered to be abnormal and of potential clinical relevance if the values measured for these parameters represented a change from baseline of greater than 20% in the direction of worsening. High diastolic blood pressure is defined as >110 mmhg and >20% increase from baseline. High systolic blood pressure is defined as >180 mmhg and >20% increase from baseline. Low systolic blood pressure is defined as <85 mmhg and >20% decrease from baseline. High heart rate is defined as >120 beats/minute and >20% increase from baseline. Low heart rate is defined as < 50 beats/minute and >20% decrease from baseline.|Up to Week 72|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.||percentage of participants|||Number
175386|NCT00077636|Secondary|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)|An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.||Percentage of participants|||Number
175377|NCT00077649|Secondary|Percentage of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities are the values outside the roche defined reference range.It is hemoglobin 11.0 – 20.0 (g/dL),platelets 100 – 700 (10^9/L), lymphocyte 1.00 – 6.30 (10^9/L),neutrophils 1.50 or more (10^9/L), white blood cells(WBC) 3.0 – 18.0 (10^9/L),serum glutamic-pyruvic transaminase (SGPT) 0 – 60 (U/L), serum glutamic oxaloacetic transaminase (SGOT) 0 – 50 (U/L), alkaline phosphatase 0 – 190 (U/L),albumin was 27.0 or more (g/L),gamma glutamyl transferases (GGT) 0 – 120 (U/L),Total protein 55 – 87 (g/L),total bilirubin 0 – 34.2 (μmol/L),BUN 0 – 14.3 (mmol/L),creatinine 0 – 154 (μmol/L),chloride 95 – 115 (mmol/L),potassium 3.0 – 6.0 (mmol/L), sodium 130 – 150 (mmol/L),thyroid stimulating hormone (TSH) 0.0 – 10.0 (mU/L),triglycerides 0.00 – 2.83 (mmol/L), calcium 2.00 – 2.90 (mmol/L),phosphate 0.75 – 1.60 (mmol/L),Blood Glucose 2.80 – 11.10 (mmol/L),Uric Acid 0 – 600 (μmol/L),proteinuria 0 – 1 (0 to 4+), glycosuria 0 – 1 (0 to 4+), hematuria 0 – 1 (0 to 4+).|Up to Week 60|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment where included in the analysis.||percentage of participants|||Number
175378|NCT00077649|Secondary|Percentage of Participants With Adverse Events and Serious Adverse Events|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is any adverse event (SAE) that can result in death or is Life-threatening or required in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above.|Up to Week 72|The safety population consisted of all participants who received at least one dose of either of the study drug and have at least one post-baseline safety assessment. Participants available at particular time point for assessment were included in the analysis.||percentage of participants|||Number
175379|NCT00077649|Secondary|Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period|Virological response at 12 weeks after the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at 12 weeks after completion of the treatment period.|Week 60|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||percentage of participants||95% Confidence Interval|Number
175380|NCT00077649|Secondary|Percentage of Participants With Virological Response at the End of the Treatment Period|Virological response at the end of the treatment period is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/mL) at the completion of the treatment period.|Week 48|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||percentage of participants||95% Confidence Interval|Number
175381|NCT00077649|Secondary|Percentage of Participants With Sustained Virological Response|SVR is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, v 2.0 (detection limit = 50 IU/ml) at the end of the 24-week untreated follow-up period.|Week 72|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||percentage of participants||95% Confidence Interval|Number
175382|NCT00077649|Primary|HCV RNA Profile During The First 24 Weeks|Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).|Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24|The ITT population consisted of all participants who were randomized and received at least one dose of either of the study medication.||log 10 copies/mL||Standard Deviation|Mean
175383|NCT00077636|Secondary|Number of Participants With Highest Triglyceride Level|Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed.|Up to Week 40 and Week 48|The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.||participants|||Number
175384|NCT00077636|Secondary|Participants With Marked Abnormal Vital Signs|Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.||participants|||Number
175385|NCT00077636|Secondary|Percentage of Participants With Marked Laboratory Abnormalities|Participants with changes in Hematocrit: Fraction 0.36 – 0.60 g/dL, Hemoglobin: 11.0 –20.0 g/dL, WBC 3.0 – 18.0 g/dL, Platelets 100 – 700 g/dL, Basophils 0.00 – 0.30 g/dL, Lymphocytes 1.00 – 6.30 g/dL, Monocytes 0.08 – 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 – 1.50 g/dL , PTT 0 – 50 seconds, Alkaline Phosphatase 0 – 190 and ASAT 0 – 50 U/L, ALAT 0 – 60 U/L, Gamma – GT 0 – 120 U/L, Total Protein 55 – 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 – 34.2 μmol/L, BUN 0 – 14.3 mmol/L, Creatinine 0 – 154 μmol/L, Free T3, T4 5 – 40 pmol/L, TSH 0.0 – 10.0 mU/L, Cholesterol 0.0 – 8.3 mmol/L; Triglycerides 0.00 – 2.83 mmol/L, Chloride 95 – 115 mmol/L; Potassium 3.0 – 6.0 mmol/L; Sodium 130 – 150 mmol/L, miscellaneous: Calcium 2.00 – 2.90 mmol/L; Phosphate 0.75 – 1.60 mmol/L; Blood Glucose (Random) 2.80 – 11.10 mmol/L, Uric Acid 0 – 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 – 1 were analysed for the laboratory abnormality.|Up to Week 40 and Week 48|Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment.||Percentage of participants|||Number
175419|NCT00077207|Secondary|Occurrence of Toxic Death|Primary safety endpoints are (1) the occurrence of toxic death, which is death during treatment that is not primarily attributable to disease progression, and (2) the occurrence of grade 4 allergy to carboplatin.|Up to 6 years||||||
175387|NCT00077636|Secondary|Percentage of Participants Virological Response 12 Weeks Post-Treatment|Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group.|Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)|Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.||Percentage of participants|||Number
175388|NCT00077636|Secondary|Percentage of Participants With Virological Response at The End of Study Treatment|Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group.|Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)|Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.||Percentage of participants|||Number
175389|NCT00077636|Primary|Percentage of Participants With Sustained Virological Response (SVR)|SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.|Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)|Standard population: The standard population includes all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations.||percentage of participants|||Number
175390|NCT00077623|Secondary|Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants|Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.||BpM||Standard Deviation|Mean
175391|NCT00077623|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study medication. Maximum number of participants available at the time of assessment were analysed and reported.||mm HG||Standard Deviation|Mean
175392|NCT00077623|Secondary|Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants|Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.||BpM||Standard Deviation|Mean
175393|NCT00077623|Secondary|Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants|Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.|From Baseline (Week -4 to Week -1) to Week 36 and Week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as ‘n’.||mmHG||Standard Deviation|Mean
175394|NCT00077623|Secondary|Number of Participants With Marked Laboratory Abnormalities|A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0– 18.0 10^9/L), platelets (100 – 550 10^9/L), alanine aminotransferase (ALAT) (0 – 110 units per liter [U/L]), alkaline phosphatase (ALP [0 – 220 U/L]), aspartate aminotransferase (ASAT) (0 – 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimoles per liter [mmol/L]), potassium (2.9 – 5.8 mmol/L), glucose (2.80 – 11.10 mmol/L).|Up to week 52|Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment were denoted as ‘n'.||participants|||Number
175395|NCT00077623|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths|An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.|Up to week 52|Safety population included all participants who received at least one dose of study drug.||participants|||Number
175396|NCT00077623|Secondary|Number of Participants With Red Blood Cell Transfusions|The number of participants who received RBC transfusions were reported.|Up to Week 36|Safety population included all participants who received at least one dose of study drug.||participants|||Number
175397|NCT00077623|Secondary|Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration|All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.|Evaluation period (Week 29 to Week 36)|The Intent-to-Treat (ITT) population included all randomized participants.||participants|||Number
175398|NCT00077623|Primary|Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods|A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.|Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)|The Per Protocol population included all randomized participants except those not meeting inclusion criterion related to stable baseline Hb values, inadequate iron status, hemoglobinopathies/hemolysis, RBC transfusion/blood loss, with <5 recorded Hb values during the evaluation period, with missing administrations of the study drug/ reference drug||g/dL||Standard Deviation|Mean
175399|NCT00077610|Secondary|Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) and Death|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. Overall deaths occurred in the study were reported.|Upto Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).||participants|||Number
175400|NCT00077610|Secondary|Mean Change in Pulse Rate (Sitting) From Baseline at Week 36 and Week 52|Change in pulse rate (beats per minute [bpm]) from baseline values includes only those participants with both a baseline value and a value for specified time period.|Baseline, Week 36 and Week 52|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).||beats per minute (bpm)||Standard Deviation|Mean
175401|NCT00077610|Secondary|Mean Change in Blood Pressure From Baseline at Week 36 and Week 52|Blood pressure was measured by manual assessment or automated reading throughout the entire study for every participant. Blood pressure was taken in the sitting position after at least 5 minutes rest. An appropriate -sized cuff was used and both systolic (SBP) and diastolic (DBP) blood pressures were recorded before dialysis (BD) and after dialysis (AD).|Baseline, Week 36 and Week 52|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).||millimeter of mercury (mmHg)||Standard Deviation|Mean
175402|NCT00077610|Secondary|Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes|Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for aspartate aminotransferase (AST) was 0-80 (unit per litre [U/L]), alanine aminotransferase (ALT) 0-110 U/L, alkaline phosphatase (ALP) 0-220 U/L, albumin >=30.0 gram/litre (g/L), glucose in non-diabetics 2.80-11.10 (millimol/litre [mmol/L]); potassium 2.90-5.80 mmol/L, and phosphorus 0.75-1.60 mmol/L|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).||participants|||Number
175403|NCT00077610|Secondary|Number of Participants With Marked Laboratory Abnormalities in Platelet, White Blood Cell Counts (WBC) and Red Blood Cells (RBC)|Marked laboratory abnormalities were defined as those values that were outside the Roche marked abnormality reference range. These abnormality laboratory values were flagged as Low or High if they were below the lower limit or above the upper limit of Roche marked abnormality reference range, respectively. The marked abnormality reference range for Platelet was 100-550x10^9/Litre [L], for WBC was 3.0-18.0.0x10^9/L, and for RBC was 3.80-6.10x10^12/L.|Up to Week 53|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not. Participants available at particular time point were included in the analysis (n).||participants|||Number
175404|NCT00077610|Secondary|The Incidence of Red Blood Cell (RBC) Transfusions During the Titration and Evaluation Periods|The number of participants who received RBC transfusions during the titration and evaluation periods were reported .|Week 1 to Week 36|The Safety Population was defined as all participants who received at least one dose of RO0503821 or Epoetin, and a safety follow-up, whether withdrawn prematurely or not.||participants|||Number
175405|NCT00077610|Secondary|Number of Participants Maintaining Average Hemoglobin Concentration During Evaluation Period Within +/- 1 Gram Per Deciliter (g/dl) of Average Baseline Hemoglobin Concentration.|The mean Hb of all values recorded during the evaluation period were calculated, and were subtracted from the mean baseline Hb for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given.|Baseline, Week 29 to Week 36|The intent-to-treat (ITT) population was defined as all randomized participants. At the end of Week 36, data allowing the evaluation of the therapeutic response was available for 196/221, 188/220, and 205/225 participants in RO0503821 (1x/2 Weeks), RO0503821 (1x/4 Weeks), and Epoetin (1 -3x/Weeks), respectively.||participants|||Number
175420|NCT00077207|Primary|Long Term Feasibility Success|"Success is defined as the completion of induction plus four cycles of maintenance within 60 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage.~If the participant completes all therapy within 60 weeks the patient is a long-term feasibility success. As such, a patient who experiences short term feasibility failure can be classified as a long-term feasibility success."|60 weeks|Fourteen (14) patients were considered not evaluable for long-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.||participants|||Number
175406|NCT00077610|Primary|Mean Change in Hemoglobin (Hb) Concentration From Baseline to Evaluation Period|A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.|Baseline, Week 29 to Week 36|The Per Protocol population included all randomized participants except those not meeting inclusion criterion related to Hb parameters and <5 recorded Hb values during the evaluation period with missing administrations of the study drug/ reference drug. Please refer to the outcome measure description section for more details.||gram per deciliter (g/dL)||Standard Deviation|Mean
175407|NCT00077376|Secondary|Kaplan-Meier Estimate of Overall Survival at 3 Years for All Treated Patients|Survival estimate from the Kaplan-Meier curve of the proportion of patients alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years|All treated patients||Percentage of Participants||95% Confidence Interval|Number
175408|NCT00077376|Secondary|Kaplan-Meier Estimate of Overall Survival at 3 Years for HER2+ Patients|Survival estimate from the Kaplan-Meier curve of the proportion of patients alive at 3 years.|Assessed every 3 months for 2 years, then every 6 months for 3 years|HER2+ patients||Percentage of Participants||95% Confidence Interval|Number
175409|NCT00077376|Secondary|Time to Treatment Failure for All Treated Patients|Time from study entry to the date at which a patient was removed from treatment due to progression, toxicity, refusal or death. If a patient was considered to be a major treatment violation or was taken off study as a non-protocol failure, the patient would be censored on the date he/she was removed from treatment.|Assessed every cycle until treatment discontinuation|All treated patients||Months||95% Confidence Interval|Median
175410|NCT00077376|Secondary|Time to Treatment Failure for HER2+ Patients|Time from study entry to the date at which a patient was removed from treatment due to progression, toxicity, refusal or death. If a patient was considered to be a major treatment violation or was taken off study as a non-protocol failure, the patient would be censored on the date he/she was removed from treatment.|Assessed every cycle until treatment discontinuation|HER2+ patients||Months||95% Confidence Interval|Median
175411|NCT00077376|Secondary|Time to Disease Progression for All Treated Patients|This interval will be measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression based on RECIST. Patients progression-free at last follow-up were censored.|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|All treated patients||Months||95% Confidence Interval|Median
175412|NCT00077376|Secondary|Time to Disease Progression for HER2+ Patients|This interval will be measured from the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression based on RECIST. Patients progression-free at last follow-up were censored.|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|HER2+ patients||Months||95% Confidence Interval|Median
175413|NCT00077376|Secondary|Objective Response for All Treated Patients (the Best Response a Patient Has Ever Experienced on Study)|"To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up.~The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks."|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|All treated patients||Participants|||Number
175414|NCT00077376|Primary|Objective Response for HER2+ Patients (Best Objective Response a Patient Has Ever Experienced on Study)|"To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up.~The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks."|Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years|HER2+ patients||Participants|||Number
175415|NCT00077207|Secondary|Response Rate Categorized as Complete Response, Partial Response, Stable Disease, or Progressive Disease|Response as complete response, partial response, stable disease, or progressive disease using three-dimensional imaging measurements (preferable) or two-dimensional imaging measurements, as well as the response in the context of multiple lesions or disseminated disease.|Up to 6 years||||||
175416|NCT00077207|Secondary|Event-free Survival (EFS)|Preliminary assessments of treatment efficacy will be based on response to induction therapy, 3-year event-free survival(EFS)|Up to 6 years||||||
175417|NCT00077207|Secondary|Progression-free Survival (PFS)|Preliminary assessments of treatment efficacy will be based on response to induction therapy, 3-year progression-free survival (PFS)|3 years||||||
175418|NCT00077207|Secondary|Grade 3 or 4 Thrombocytopenia and/or Neutropenia|Grade 3 or 4 thrombocytopenia and/or neutropenia that results in more than a 3 week delay in instituting the next cycle of chemotherapy despite protocol-directed reduction of up to 25% in Carboplatin and/or Temozolomide during the first 60 weeks of therapy|Up to 6 years||||||
175421|NCT00077207|Primary|Short Term Feasibility Success|"Success is defined as the completion of induction plus one cycle of maintenance within 24 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage.~Failure to complete the induction and one cycle of maintenance within 24 weeks counts as a short-term-feasibility failure."|24 weeks|Fourteen (14) patients were considered not evaluable for short-term toxicity because: ineligible - 1 patient; progression during induction - 9 patients; progression during maintenance 2 patients; parent preference - 1 patient and infection resulting in termination of protocol therapy - 1 patient.||participants|||Number
175422|NCT00076999|Primary|Number of Patients With Severe (DAIDS Grades 3 or 4) Laboratory Abnormalities by Age Group and Formulation|Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.|up to 288 weeks|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.||participants|||Number
175423|NCT00076999|Primary|Number of Severe (DAIDS Grades 3 or 4) Adverse Events Related to Drug for Treated Patients by Age Group and Formulation|Intensity of adverse events were graded by the investigator based on the DAIDS standardized table (Division of AIDS, National Institute of Health). DAIDS Grade 3 (Severe) and Grade 4 (Life Threatening) were identified.|up to 288 weeks|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment.||participants|||Number
175424|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 48||week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
175425|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 24||week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
175426|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 16||week 16|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
175427|NCT00076999|Secondary|Number Patients With Compliance With Tipranavir Treatment Between 95 and 120 Percent at Week 8||week 8|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
175428|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 100 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||percentage of cells||Inter-Quartile Range|Median
175429|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 48 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||percentage of cells||Inter-Quartile Range|Median
175430|NCT00076999|Secondary|Median Change From Baseline in CD4 Percent at Week 24 (Last Observation Carried Forward)|Percentage of lymphocytes that are CD4 cells|baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||percentage of cells||Inter-Quartile Range|Median
175431|NCT00076999|Secondary|Median Baseline CD4 Percent|Percentage of lymphocytes that are CD4 cells|baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||percentage of cells||Inter-Quartile Range|Median
175432|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 100 (Last Observation Carried Forward)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||cells/mm3||Inter-Quartile Range|Median
175433|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 48 (Last Observation Carried Forward)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||cells/mm3||Inter-Quartile Range|Median
175434|NCT00076999|Secondary|Median Change From Baseline in CD4+ Cell Count (Cells/mm3) at Week 24 (Last Observation Carried Forward)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||cells/mm3||Inter-Quartile Range|Median
175435|NCT00076999|Secondary|Baseline Median CD4+ Cell Count (Cells/mm3)||baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||cells/mm3||Inter-Quartile Range|Median
175436|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 100 (Last Observation Carried Forward)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||log10 copies/mL||Inter-Quartile Range|Median
175437|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 48 (Last Observation Carried Forward)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||log10 copies/mL||Inter-Quartile Range|Median
175438|NCT00076999|Secondary|Median Change From Baseline in Viral Load log10 Copies/mL at Week 24 (Last Observation Carried Forward)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||log10 copies/mL||Inter-Quartile Range|Median
175439|NCT00076999|Secondary|Baseline Median Viral Load log10 Copies/mL||baseline|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||log10 copies/mL||Inter-Quartile Range|Median
175440|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 100 (Non-completers Considered Failures)||baseline, week 100|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
175441|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 48 (Non-completers Considered Failures)||baseline, week 48|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
175442|NCT00076999|Secondary|Number Patients With HIV RNA <50 Copies/mL at Week 24 (Non-completers Considered Failures)||baseline, week 24|Full Analysis Set included all patients treated with study medication having at least one on-treatment efficacy assessment||participants|||Number
175455|NCT00076687|Secondary|Change From Baseline in Ashworth Scale|Change from Baseline in worst upper limb scores using the Ashworth Scale at Week 6 from Baseline. Upper limb includes finger, wrist, thumb, and elbow. Worst score was the highest value measured from the finger, wrist, thumb, or elbow at Baseline and Week 6 based on treated areas. The Ashworth Scale assesses the degree of muscle tone. It is a 5-point scale where 0 equals no increase in muscle tone and 4 equals very severe muscle rigidity. A low score indicates little or no stiffness. A high score indicates severe stiffness. A negative change from baseline score indicates improvement.|Baseline, Week 6|Intent to Treat||Number on a scale||Standard Deviation|Mean
175456|NCT00076687|Secondary|Change From Baseline in FEV1/FVC Ratio|Change from baseline in FEV1/FVC ratio. This ratio is calculated by dividing the FEV1 value by the FVC value. This represents that portion (or ratio) of FVC exhaled in one second.|Baseline, Week 6|Safety||Ratio||Standard Deviation|Mean
175457|NCT00076687|Primary|Change From Baseline in Forced Expiratory Volume (FEV1)|Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.|Baseline, Week 6|Safety||Liters of air||Standard Deviation|Mean
175458|NCT00076687|Primary|Change From Baseline in Forced Vital Capacity (FVC)|Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.|Baseline, Week 6|Safety||Liters of air||Standard Deviation|Mean
175459|NCT00076570|Secondary|The Rate of Significant Drug-associated Complications.||3 years|||participants|||Number
175460|NCT00076570|Primary|The Rate of Allograft Rejection||3 years|||participants|||Number
175461|NCT00075400|Secondary|p-AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue|Potential associations with clinical or PFS response will be assessed.|Baseline||||||
175462|NCT00075400|Secondary|AKT2 Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC|Potential associations with clinical or PFS response will be assessed.|Baseline||||||
175463|NCT00075400|Secondary|PDGFR Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by IHC|Potential associations with clinical or PFS response will be assessed.|Baseline||||||
175464|NCT00075400|Secondary|c-KIT Expression Levels in Archived, Formalin-fixed, Paraffin-embedded Primary Tumor Tissue by Immunohistochemistry (IHC)|Potential associations with clinical or PFS response will be assessed.|Baseline||||||
175465|NCT00075400|Secondary|Initial Histologic Grade|Assessed as a prognostic factor.|Baseline||||||
175466|NCT00075400|Secondary|Initial Performance Status|Assessed as a prognostic factor.|Baseline||||||
175467|NCT00075400|Secondary|Duration of PFS||Up to 5 years||||||
175468|NCT00075400|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact|From study entry to death or last contact, up to 5 years.|Eligible and treated patients||months||95% Confidence Interval|Median
175469|NCT00075400|Secondary|Tumor Response|Complete and Partial Tumor Response by RECIST 1.0|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter.|Eligible and treated patients||percentage of participants||90% Confidence Interval|Number
175470|NCT00075400|Primary|Incidence of Adverse Effects as Assessed by CTCAE v 3.0|The frequency and severity of all toxicities are tabulated from submitted case report forms and summarized for review.|Up to 5 years||||||
175471|NCT00075400|Primary|Progression-free Survival (PFS) > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow measurable disease every other cycle for the first 6 months; every 6 months thereafter.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
175472|NCT00075270|Secondary|Number of Participants With the Indicated Adverse Events (AEs) With a Maximum Toxicity Grade of 3 or 4|The severity of adverse events was graded per the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3. Grades 1 through 5 have unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1, Mild AE; Grade 2, Moderate AE; Grade 3, Severe AE; Grade 4, Life-threatening or disabling AE; Grade 5, death related to AE.|Baseline (Day 1) until 30 days after the last dose of randomized therapy (average of 26 weeks)|Safety Population: all randomized participants who received at least one dose of investigational product (based on the actual treatment received if this differed from that to which the participant was randomized). Two participants randomized to the placebo group actually received lapatinib.||participants|||Number
175473|NCT00075270|Secondary|Serum ErbB2 Concentration|The Quest Laboratory collected blood samples for quantitative determination of serum ErbB2. The results of serum monitoring were used to compare tumor response rates following randomized therapy.|Screening (Day-1) and Withdrawal (up to Study Week 129)|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.||ng/mL||Standard Deviation|Mean
175474|NCT00075270|Secondary|Serum ErbB1 Concentration|The Quest Laboratory collected blood samples for quantitative determination of serum ErbB1. The results of serum monitoring were used to compare tumor response rates following randomized therapy.|Screening (Day-1) and Withdrawal (up to Study Week 129)|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.||Nanograms per milliliter (ng/mL)||Standard Deviation|Mean
175475|NCT00075270|Secondary|Number of Participants With the Indicated ErbB2 Fluorescence in Situ Hybridization (FISH) Results|"The Press Laboratory tested participants who were 2+ (weak to moderate complete staining) or 3+ (strong complete staining) for ErbB2 overexpression by IHC for ErbB2 gene amplification using the FISH assay. The results of the FISH assay can be ErbB2 gene amplification (increased number of copies of the ErbB2 gene) or non-amplification (not many copies of the ErbB2 gene). A status of Assay not done was assigned to those participants with no available samples and to those with inconclusive results (e.g., due to hybridization or staining problems)."|Baseline|ITT Population||participants|||Number
175476|NCT00075270|Secondary|Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening|"The Press Laboratory tested tumor tissue samples (taken at Screening, prior to randomization to study treatment) to determine intra-tumoral expression levels of ErbB1, ErbB2, and other analytes associated with these pathways by IHC, the process of detecting antigens (e.g., proteins) in cells of a tissue section. The IHC assessment is expressed as: 0, no staining (no cancer cells); 1+, faint staining; 2+, weak to moderate complete staining; 3+, strong complete staining (many cancer cells). A status of Assay not done was assigned to participants with no available samples and to those with inconclusive results. If strong staining is observed, breast cancer that has high levels of HER2 expression (overexpression) is indicated. If moderate/weak staining is observed (IHC=2+), breast cancer that has low/moderate expression levels is indicated. When no staining is observed (IHC=0), breast cancer HER2 expression may be below the level of detection of the assay."|Screening (Day -1)|ITT Population||participants|||Number
175477|NCT00075270|Secondary|ErbB2 Ratio|The Press Laboratory collected tumor tissues of participants for biomarker testing. All samples were analyzed by the Press Laboratory. The ratio of ErbB2 gene signals to chromosome 17 signals, which indicates the progression of breast cancer, was calculated. Low levels of amplification (few copies) may have a ratio of 2-5, whereas high levels of amplification may have a ratio >10.|Baseline|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.||ratio of signals||Standard Deviation|Mean
175478|NCT00075270|Secondary|Number of Participants With the Indicated ErbB2 Status at Baseline|The Press Laboratory collected tumor tissues of participants for ErbB2 testing. ErbB2 testing is done to detect breast cancer and predict its likely outcome. All samples were analyzed by the Press Laboratory. Participants were categorized as ErbB2 positive (overexpression of the ErbB2 gene), ErbB2 negative, and assay not done (which included participants with no available samples and those with inconclusive results). ErbB2 status is determined by immunohistochemistry (ICH) assay and fluorescence in situ hybridization (FISH) testing. Negative ErbB2 status is defined as 0 or 1+ by IHC, or as 2+ by IHC and FISH.|Baseline|ITT Population||participants|||Number
175479|NCT00075270|Secondary|Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores|The TOI questionnaire was designed to measure multidimensional QOL in participants with cancer and includes subscales for physical, functional well-being, and additional cancer concerns. The physical and functional well-being subscale scores range from 0 to 28, based on 7 questions (each question scored from 0 [not at all] to 4 [very much]); the breast cancer unweighted subscale scores range from 0 to 36, based on 9 questions. The total TOI score (ranging from 0 [better QOL] to 92 [worse QOL]) is the sum of the TOI subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.||Scores on a scale||Standard Deviation|Mean
175480|NCT00075270|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores|The FACT-G questionnaire was designed to measure multidimensional QOL in participants with cancer and includes subscales for physical, social/family, emotional, and functional well-being. The physical, social/family, and functional well-being subscale scores range from 0 to 28, based on responses to 7 questions (each question scored from 0 [not at all] to 4 [very much]); the emotional well-being subscale score ranges from 0 to 24, based on responses to 6 questions. The FACT-G Total Score (ranging from 0 [better QOL] to 108 [worse QOL]) is the sum of the subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the LOCF method.||Scores on a scale||Standard Deviation|Mean
175481|NCT00075270|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores|The FACT-B questionnaire was designed to measure multidimensional quality of life (QOL) in participants with breast cancer. The physical and functional well-being subscale scores range from 0 to 28, based on 7 questions (each scored from 0 [not at all] to 4 [very much] for all subscales); the emotional and social/family well-being (1 question optional) subscale scores range from 0 to 24 (based on 6 questions), and the additional concerns subscale score ranges from 0 to 40, based on 10 questions. The FACT-B Total Score (0 [better QOL] to 144 [worse QOL]) is the sum of the subscale scores.|Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal|ITT Population. Only participants contributing data at the indicated time points were analyzed. Only observed data were collected, and score analyses were conducted using the last observation carried forward (LOCF) method: the last available on-therapy observation for a participant was used to estimate missing data points.||Scores on a scale||Standard Deviation|Mean
175482|NCT00075270|Secondary|Overall Survival|Overall survival is defined as the time from randomization until death due to any cause.|Randomization until the date of death due to any cause (average of 24 months)|ITT population. Overall survival was assessed in participants who died as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those still alive), the date of the last contact was used.||months||95% Confidence Interval|Median
175483|NCT00075270|Secondary|Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause, if sooner. Six months PFS is defined as PFS at six months from the time of randomization. Raw data for 6 months PFS are not available; thus, data are presented as the number of participants who progressed or died at or prior to 6 months. For TLs, progressive disease is defined asat least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. PFS was assessed in participants who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population||participants|||Number
175525|NCT00075829|Secondary|Incidences of Chronic GVHD|Incidence and severity of chronic GVHD will be scored according to the BMT clinical trials network Manual of Procedures.|Years 1 and 2|GVHD was only assessed on the Auto-Allo arm for standard risk patients that completed second transplant||percentage of patients||95% Confidence Interval|Number
175484|NCT00075270|Secondary|Progression-Free Survival (PFS)|PFS is defined as the interval between the date of randomization and the earliest date of progression disease (PD) or death due to any cause, if sooner. For TLs, progressive disease is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. par., participants.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population. PFS was assessed in par. who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored par. (those without a documented date of disease progression/death due to any cause), the date of the last radiographic assessment was used.||weeks||95% Confidence Interval|Median
175485|NCT00075270|Secondary|Duration of Response (DOR)|The investigator evaluated the DOR for the subset of participants who showed a CR (disappearance of all TLs and NTLs) or PR (TLs: a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; NTLs: persistence of >=1 lesion). DOR is defined as the time from the first documented evidence of PR or CR until the first documented sign of PD (TL: a >=20% increase in the sum of the LD of TLs or the appearance of >=1 new lesion; NTL: the appearance of >=1 new lesion and/or unequivocal progression of existing NTLs) or death due to breast cancer, if sooner.|From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks)|ITT Population. Only participants who had a CR or PR were evaluated.||weeks||Inter-Quartile Range|Median
175486|NCT00075270|Secondary|Number of Participants With a Response of CR or PR by the Indicated Study Week|Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR (disappearance of all TLs and NTLs) or PR (for TLs: a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; for NTLs: the persistence of >=1 lesion) (whichever status was recorded first). TTR data are displayed as the number of participants achieving a CR or PR by the indicated week. The investigator evaluated the TTR, and the analysis was based on responses confirmed at a repeat assessment, with the TTR taken as the first time the response was observed.|Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72|ITT Population||participants|||Number
175487|NCT00075270|Secondary|Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator|Percentage of participants. with CB is defined as the percentage of participants with evidence of CR (disappearance of all TLs and NTLs), PR (TLs: a >=30% decrease in the sum of the LD, taking as a reference the Baseline sum LD; NTLs: persistence of >=1 lesion), or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) for >=6 months based on RECIST criteria. PD for TL: a >=20% increase in the sum of the LD of TLs or the appearance of >=1 new lesion. PD for NTLs: the appearance of >=1 new lesion and/or unequivocal progression of existing NTLs.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population||Percentage of participants|||Number
175488|NCT00075270|Secondary|Number of Participants With Tumor Response as Evaluated by the Independent Review Committee|The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The RECIST criteria was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population||participants|||Number
175489|NCT00075270|Secondary|Number of Participants With Tumor Response as Evaluated by the Investigator|The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The Response Evaluation Criteria in Solid Tumors (RECIST) was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population||participants|||Number
175490|NCT00075270|Primary|Time to Progression as Evaluated by the Independent Review Committee (IRC)|Time to progression is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The IRC assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the independent reviewer, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|ITT Population||weeks||Inter-Quartile Range|Median
175491|NCT00075270|Primary|Time to Progression as Evaluated by the Investigator|Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.|Randomization until the date of disease progression or death (average of 26 weeks)|Intent-to-Treat (ITT) Population: all randomized participants who had received at least one dose of randomized therapy (lapatinib or placebo)||weeks||Inter-Quartile Range|Median
175641|NCT00074269|Primary|Incidence and Severity of Acute and Chronic Graft-versus-host Disease (GVHD)||post treatment||||||
175492|NCT00076336|Secondary|Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score|Modified CTP was calculated using the 3 biochemical-components (serum bilirubin, albumin, and prothrombin). Total scores range from 3-9; higher scores indicate more liver impairment. Improvement was defined as 2-point or greater reduction in score from baseline. Stabilization comprises a score change of 1-point or less from baseline. Worsening of CTP score was defined as a 2-point or greater increase from baseline. The rationale for assessing changes in this modified (3-component) CTP score is that this maneuver removed the two subjective components of CTP scoring (ascites and encephalopathy).|Baseline and Week 104|"The analysis was done on the intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as worsening CTP."||Participants|||Number
175493|NCT00076336|Secondary|Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104|Child-Turcotte-Pugh (CTP) uses 2 clinical variables, ascites and encephalopathy, and 3 laboratory parameters, serum bilirubin, albumin, and prothrombin time. Each variable is assigned a score from 1 to 3, with the combined score comprising the CTP score range of 5 to 15 points. Higher scores indicate more impaired liver function. “Worsening” of CTP score was defined as a 2-point or greater increase from baseline, “improvement” in CTP score was defined as a 2-point or greater reduction from baseline, and “stabilization” of CTP score was defined as a change of 1-point or less from baseline.|From Baseline to weeks 52 and 104|"The analysis was done per intention-to-treat (ITT) population. Last Observation Carried Forward (LOCF) was utilized for missing data, with the exception of missing observations due to treatment failure, death or AE, which were imputed as worsening CTP."||Participants|||Number
175494|NCT00076336|Secondary|Duration of Initial Clinical Response|Kaplan-Meier method was used. The duration was calculated as: date of last visit before initial loss of clinical response – date of initial clinical response occurred+1. If a patient did not lose clinical response, it was then censored at the efficacy overall censoring date.|Baseline to Week 104|The analysis was on intention-to-treat (ITT) population. Only patients who achieved clinical response were considered.||Days||Standard Error|Mean
175495|NCT00076336|Secondary|Time to Initial Clinical Response|Time to Clinical Response defined as the number of days elapsed from the baseline visit to achieving initial Clinical Response.|From Baseline to Week 104|The analysis was on intention-to-treat (ITT) population. Only the observed time to initial clinical response was summarized.||Days||Standard Deviation|Mean
175496|NCT00076336|Primary|Number of Participants With Clinical Response|Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA < 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT ≤ Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met.|From Baseline to Week 52|The analysis was on the intention-to-treat (ITT) population.||Participants|||Number
175497|NCT00076258|Primary|Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)|The primary outcome measure- percentage of participants with remission (score of 12 or less on Inventory for Depressive Symptomatology- Clinician-rated). The change over time in probability of remission (IDS-C30 score ≤ 12) was compared between groups using a generalized linear mixed model (GLMM)41 as implemented in SAS (Proc Glimmix; SAS Institute Inc, Cary, North Carolina).|12 weeks|||percentage of participants in remission|||Number
175498|NCT00076245|Primary|Remission Status on Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD)|Dichotomous Remission Status (remitted or not) at post-treatment|Post-treatment|||participants|||Number
175499|NCT00076245|Primary|Scores on the Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version|The Structured Interview Guide for the Hamilton Depression Rating Scale—Seasonal Affective Disorder Version (SIGH-SAD) measures depressive symptoms on a continuous scale. Higher scores indicate worse outcome. Range of scores is 0 to 73. Generally, a score of 20 or higher is the cutoff for clinical depression.|Post-treatment|||units on a scale||Standard Deviation|Mean
175500|NCT00076219|Primary|60-day All-cause Mortality|60-day all-cause mortality|60 days|Number of all-cause mortality by day 60||participants|||Number
175501|NCT00076102|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years|||Participants|||Number
175502|NCT00076102|Primary|Median Time to Disease Progression|Time to progression is defined as greater than or equal to 20% increase in plexiform neurofibromas (PN) volume on magnetic resonance imaging (MRI).|5 years|||Months||95% Confidence Interval|Median
175503|NCT00076050|Secondary|Change in Vaginal Maturation Value|The Vaginal Maturation Value (VMV) describes the proportion of the three vaginal epithelial cell types (parabasal, intermediate and superficial) obtained from a swab of the vaginal walls. The changes in the proportion of each type of cells reflects the degree of exposure to estrogen of the vaginal epithelium. The VMV lists the percentage of each type of cell appearing on the smear, with the total of all three values equaling 100%. The index is read from left to right; i.e. VMI of 5/40/55 represents 5% parabasal cells, 40% intermediate cells and 55% superficial cells. Exposure to estrogens results in some parabasal cells, a greater proportion of intermediate cells and few superficial cells.|baseline and 2 years|||score||Standard Error|Mean
175504|NCT00076050|Secondary|Changes in Women's Health Questionnaire Score|This self-administered questionnaire contains 23 items, distributed among 6 factors: anxiety and depressed mood (7 items), well-being (4 items), somatic symptoms (5 items), memory and concentration (3 items), vasomotor symptoms (2 items) and sleep problems (2 items). The instrument has a structured format and the response choices consist of 4-point Likert scales (‘yes definitely’ to ‘no, not at all’). Item scores are collapsed into a dichotomous scale, where higher scores indicate a greater level of symptomatology or difficulty; i.e., if the response is 1 or 2 (positive response), the score = 1; if the response is 3 or 4 (negative response), the score is 0. Results can be reported as a total score, where the range is 0-23, but also for each dimension. Thus, the ranges of the subscales are: for anxiety and mood 0-7, for well-being 0-4, somatic symptoms 0-5, memory and concentration 0-3, vasomotor symptoms 0-2 and sleep problems 0-2.|baseline and 2 years|||change in score||Standard Error|Mean
175506|NCT00076024|Other Pre-specified|Population Pharmacokinetics of Axitinib (AG-013736) for Phase 2 (Double-blind)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose), Day 22 and Day 43 and then every 9 weeks up to 129 weeks||||||
175507|NCT00076024|Secondary|Duration of Response (DR) for Phase 2 (Open-label)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks|Subgroup of participants from the AT population with a confirmed objective tumor response (CR or PR).||days||95% Confidence Interval|Median
175508|NCT00076024|Secondary|Duration of Response (DR) for Phase 2 (Double-blind)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Phase 2 double-blind baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 9 weeks up to 129 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).||days||95% Confidence Interval|Median
175509|NCT00076024|Secondary|Percentage of Participants With Objective Response (OR) for Phase 2 (Open-label)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Phase 2 open-label baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 58 weeks|All treated (AT) population included participants from Phase 2 who progressed by RECIST criteria while in the placebo + docetaxel treatment group and had a baseline disease assessment and received at least 1 dose of study medication.||percentage of participants||95% Confidence Interval|Number
175510|NCT00076024|Secondary|Percentage of Participants With Objective Response (OR) for Phase 2 (Double-blind)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Phase 2 double- blind baseline until the date of first documented progression or discontinuation from the study treatment due to any cause, assessed every 9 weeks up to 129 weeks|Study population included all randomized participants who had a baseline assessment of disease and the correct histological cancer type.||percentage of participants||95% Confidence Interval|Number
175511|NCT00076024|Primary|Time to Tumor Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as first event date minus the date of first dose of study medication plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Phase 2 double-blind baseline until tumor progression or death or discontinuation from study treatment, assessed every 9 weeks up to 129 weeks|Study population included all randomized participants who had a baseline assessment of disease and the correct histological cancer type.||days||95% Confidence Interval|Median
175512|NCT00076011|Other Pre-specified|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks up to 139 weeks||||||
175513|NCT00076011|Secondary|Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) Score|EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.|Baseline, Days 29, 57, 113, 169, 225, 281, 337, 393, 449, 505, 561, 617, 673, 729, 785, 841, 897, 953 and follow-up visit after last dose|Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease. The 'n' is signifying those participants who were evaluable for this measure at the specified time point.||Units on a scale||Standard Deviation|Mean
175514|NCT00076011|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event (AE) data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least 1 year after the initial dose for the last treated participant|Study population included all participants who received at least 1 dose of study medication.||Days||95% Confidence Interval|Median
175642|NCT00074269|Primary|Facilitation of Long-term Engraftment||post treatment||||||
175643|NCT00074269|Primary|Adverse Events Rate||5 years post transplant|||percentage of participants|||Number
175515|NCT00076011|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Subgroup of participants from the study population with a confirmed objective tumor response (CR or PR).||Days||95% Confidence Interval|Median
175516|NCT00076011|Secondary|Time to Disease Progression (TTP)|Time in days from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first. TTP was calculated as (first event date minus the date of first dose of study medication plus 1). Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Study population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.||Days||95% Confidence Interval|Median
175517|NCT00076011|Primary|Percentage of Participants With Objective Response (OR)|Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 139 weeks|Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.||Percentage of participants||95% Confidence Interval|Number
175518|NCT00075946|Secondary|Overall Health-related Quality of Life (HRQL) at 6 Month After Randomization|The overall HRQL was measured by the change in Functional Assessment of Cancer Therapy - General (FACT-G) from baseline to 6 months after randomization. The FACT-G is a 27-item assessment used to measure HRQL, specifically, physical, functional, social and emotional well-being. The total score ranges from 0 to 108, with higher scores indicating better HRQL.|Assessed at baseline and 6 months after randomization.|Patients with patient-reported outcomes (PRO) data available.||units on a scale||Standard Deviation|Mean
175519|NCT00075946|Secondary|Time to First Cytotoxic Therapy (TTFC)|TTFC is defined as the time from randomization to the time of first cytotoxic therapy (chemo and radio therapy), and censored as last follow-up time if no cytotoxic therapy has been used. Since median TTFC was not reached in 3 out of the 4 groups, 3-year TTFC was reported which was defined as the probability of not starting first cytotoxic therapy at 3 years.|Assessed every 13 weeks until rituximab failure observed or August 2013, whichever occurred first.|Patients who were correctly randomized to one of the two maintenance arms.||probability||95% Confidence Interval|Number
175520|NCT00075946|Primary|Time to Rituximab Failure (TTRF)|TTRF is defined as the time from randomization until any one of the following criteria are met, and censored at last disease assessment for cases who have not experienced failure (with the cut-off date for final analysis of 11/1/2011): 1. No response (partial response (PR) or complete response (CR)) to rituximab retreatment (Arm A treatment). 2. Time to progression < 26 weeks from day 1 of most recent rituximab treatment. 3. Initiation of alternative therapy. 4. Inability to complete protocol therapy (due to adverse events, patient preference, or any other reason, including death).|Assessed (by restaging CT scans) 26 weeks ± 2 weeks from each rituximab treatment (including induction), counting the first rituximab dose as Day 1, until rituximab failure observed or July 17, 2013, whichever occurred first.|Eligible patients who were randomized to one of the two arms for maintenance therapy.||years||95% Confidence Interval|Median
175521|NCT00075881|Secondary|1-year Progression Free Survival Probability|Progression-free survival is defined as time from randomization to disease progression or death from any cause, whichever occurred first. Disease progression is defined using the ECOG Myeloma Response Criteria. Kaplan-Meier method is used to estimate the 1-year progression-free survival probability. 42 eligible and treated patients were included in the analysis.|Every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-6 years from study entry, no specific requirment if patient is more than 6 years from study entry|42 eligible and treated patients||percentage of participants||95% Confidence Interval|Number
175522|NCT00075881|Secondary|Response Rate on Reinduction|ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 7 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 23 cycles with a median number of 3 cycles. 1 cycle=21 days|7 eligible and treated patients were included in the analysis.||percentage of participants||90% Confidence Interval|Number
175523|NCT00075881|Secondary|Response Rate on Maintenance|ECOG Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 15 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 45 cycles with a median number of 9 cycles. 1 cycle=21 days|15 eligible and treated patients were included in the analysis.||percentage of participants||90% Confidence Interval|Number
175524|NCT00075881|Primary|Response Rate on Induction|Eastern Cooperative Oncology Group (ECOG) Myeloma Response Criteria that follows the standard European Group for Blood and Bone Marrow Transplant criteria was used to evaluate patient response and progression. Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have complete response. 42 eligible and treated patients were included in the analysis.|participants were evaluated prior to each cycle, up to 8 cycles with a median number of 6 cycles. 1 cycle=21 days|42 eligible and treated patients were included in the analysis.||percentage of participants||90% Confidence Interval|Number
175644|NCT00074165|Secondary|Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment||2 years||||||
175526|NCT00075829|Secondary|Incidences of Graft Versus Host Disease (GVHD)|Incidence and severity of GVHD will be scored according to the BMT clinical trials network Manual of Procedures.|Day 100|GVHD was only assessed on the Auto-Allo arm for standard risk patients that completed second transplant||percentage of patients||95% Confidence Interval|Number
175527|NCT00075829|Secondary|Interval From First to Second Transplantation|Upon recovery from the first autograft, but at least 60 days (preferably between 60-120 days) after the first autograft, patients will receive a second transplant according to treatment assignments.|Year 1|Patients that completed second transplant||days||Full Range|Median
175528|NCT00075829|Secondary|Cumulative Incidence of Treatment Related Mortality (TRM)|TRM is defined as death occurring in a patient from causes other than relapse or progression.|Year 3|Patients that completed second transplant||percentage of participants||95% Confidence Interval|Number
175529|NCT00075829|Secondary|Cumulative Incidence of Progression/Relapse|Patients are considered experiencing an event when they progress. Deaths without progression are considered as a competing risk. Patients initiating non-protocol anti-myeloma therapy are considered to have progressed on this protocol.|Year 3|Patients that completed second transplant||percentage of patients||95% Confidence Interval|Number
175530|NCT00075829|Secondary|Overall Survival (OS) for High Risk|The event is death from any cause, patients alive at the time of last observation are considered censored.|Year 3|Patients that completed second transplant||percentage of participants||95% Confidence Interval|Number
175531|NCT00075829|Secondary|Overall Survival (OS) for Standard Risk|The event is death from any cause, patients alive at the time of last observation are considered censored.|Years 1, 2, and 3|Patients that completed second transplant||percentage of patients||95% Confidence Interval|Number
175532|NCT00075829|Primary|Progression-Free Survival (PFS)|Patients are considered a failure for this endpoint if they die or if they progress or relapse.|Year 3|Patients that completed second transplant||percentage of patients||95% Confidence Interval|Number
175533|NCT00075816|Secondary|Patient Quality of Life||Measured at baseline, 6 months, and 1, 2, and 5 years|No data collected|||||
175534|NCT00075816|Secondary|Donor Quality of Life||Measured at 1, 6, and 12 months|No data collected|||||
175535|NCT00075816|Secondary|Donor Recovery to Baseline Toxicity Scores||Measured at 1, 6, and 12 months|No data collected|||||
175536|NCT00075816|Secondary|Donor Recovery of Baseline Complete Blood Count (CBC) and White Blood Cell Count (WBC) Differential||Measured at 1, 6, and 12 months|No data collected|||||
175537|NCT00075816|Secondary|Immune Reconstitution||Measured at 100 days, 6 months, and 1 and 2 years|No data collected|||||
175538|NCT00075816|Secondary|Current Immunosuppressive (IS) Free Survival|This outcome measure takes into account subsequent immunosuppressive therapy that may occur following discontinuation of initial immunosuppressive therapy.|Measured at 2 years|No data collected.|||||
175539|NCT00075816|Secondary|Acute GVHD Grade III-IV||100 days, 180 days|||percentage of patients||95% Confidence Interval|Number
175540|NCT00075816|Secondary|Acute GVHD Grade II-IV||100 days, 180 days|||percentage of patients||95% Confidence Interval|Number
175541|NCT00075816|Secondary|Grades III-V Unexpected Adverse Events||Measured by 2 years|||participants|||Number
175542|NCT00075816|Secondary|Infections|Number of infection reports per patient.|Measured at 1 and 2 years|Analysis restricted to patients who received the transplant.||participants|||Number
175543|NCT00075816|Secondary|Relapse|Analysis restricted to patients who received the transplant.|Measured at 2 years|||percentage of patients||95% Confidence Interval|Number
175544|NCT00075816|Secondary|Chronic GVHD||Measured at 2 years|||percentage of participants||95% Confidence Interval|Number
175545|NCT00075816|Secondary|Extensive Chronic Graft-versus-host Disease (GVHD)||Measured at 730 days|||percentage of patients||95% Confidence Interval|Number
175546|NCT00075816|Secondary|Graft Failure||Measured at 28 and 100 days|||percentage of patients||95% Confidence Interval|Number
175547|NCT00075816|Secondary|Platelet Engraftment||Measured at Day 180|||percentage of patients||95% Confidence Interval|Number
175548|NCT00075816|Secondary|Neutrophil Engraftment||Measured at Day 28|||percentage of patients|||Number
175549|NCT00075816|Primary|Two-year Overall Survival|Overall survival rate at 2 years according to an intention-to-treat analysis.|Measured at 2 years|||percentage of patients||95% Confidence Interval|Number
175550|NCT00075803|Secondary|Freedom From Possible, Presumptive, Probable, or Proven Invasive Fungal Infection, Death, or Withdrawal of Study Drug Due to Toxicity, Intolerance, or an Empirical Trial of Amphotericin B or Caspofungin Greater Than 14 Consecutive Days||1 year|||participants|||Number
175551|NCT00075803|Secondary|Failure to Engraft||day 42|||participants|||Number
175552|NCT00075803|Secondary|Time to Platelet Engraftment||180 days||||||
175553|NCT00075803|Secondary|Time to Neutrophil Engraftment||28 days||||||
175554|NCT00075803|Secondary|Utility of Galactomannan Assay in Diagnosis of Aspergillus and Response to Therapy|Although there were 82 Galactomannan (GM) positives, 4 were excluded due to piperacillin/tazobactam administration, without other documentation of IFI, and were deemed false positives.|1 year|||participants|||Number
175555|NCT00075803|Secondary|Time to and Severity of Acute and Chronic Graft vs Host Disease (GVHD)||100 and 365 days|||participants|||Number
175556|NCT00075803|Secondary|Duration of Use of Amphotericin B or Caspofungin||180 days|||days||Inter-Quartile Range|Mean
175557|NCT00075803|Secondary|Frequency of Use of Amphotericin B or Caspofungin||1 year|||percentage of patients||95% Confidence Interval|Number
175558|NCT00075803|Secondary|Relapse Free Survival||100, 180, and 365 days|||percentage of patients||95% Confidence Interval|Number
175559|NCT00075803|Secondary|Overall Survival||100, 180, and 365 days|||percentage of patients||95% Confidence Interval|Number
175560|NCT00075803|Secondary|Percentage of Patients With Invasive Fungal Infection at 100, 180, and 365 Days||100, 180, and 365 days|||percentage of patients||95% Confidence Interval|Number
175561|NCT00075803|Secondary|Frequency of Invasive Fungal Infections (IFI)|Incidence of proven, probably, or presumptive IFI|1 year|||percentage of patients||95% Confidence Interval|Number
175562|NCT00075803|Primary|Fungal-free Survival (Percentage of Participants Alive and Free From Proven, Probable, or Presumptive Invasive Fungal Infection) at 180 Days Post-transplant||180 days|All randomized patients were included in the analysis||percentage of patients||95% Confidence Interval|Number
175563|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).|Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells.|5 years|Group “Prednisone and High Dose MTX (non-random)” who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up.||percentage of participants||95% Confidence Interval|Number
175564|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)|Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells.|5 years|"Groups Prednisone Capizzi MTX (Down's Syndrome), Dexamethasone, Capizzi MTX (non-random) & Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up."||percentage of participants||95% Confidence Interval|Number
175565|NCT00075725|Secondary|Correlation of Early Marrow Response Status With MRD Negative.|Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|Day 29|||participants|||Number
175566|NCT00075725|Secondary|Correlation of Early Marrow Response Status With MRD Positive.|Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|Day 29|||participants|||Number
175567|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).|Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells.|5 years|"Patients on Arm/Group Prednisone and High Dose Methotrexate (non randomly assigned) are not included in the OM as there were no survivors for the 5 year duration. Cohort of MRD Negative patients some of whom have had EFS/OS events after 5 years or have minimum 5 years of follow-up."||percentage of participants||95% Confidence Interval|Number
175568|NCT00075725|Secondary|Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)|Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells.|5 Years|"Groups Prednisone Capizzi MTX (Down's Syndrome), Dexamethasone, Capizzi MTX (non-random) & Prednisone and High Dose MTX (non-random) are not included in this OM as no patients survived the 5 year window for analysis. Cohort of MRD Positive patients who either had EFS/OS events occur before 5 years or did not have minimum 5 years of follow-up."||percentage of participants||95% Confidence Interval|Number
175569|NCT00075725|Primary|Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions|Event Free Probability.|5 years|Group “Prednisone and High Dose MTX (non-random)” who either had EFS events occur before 5 years or did not have minimum 5 years of follow-up.||percentage of participants||95% Confidence Interval|Number
175570|NCT00075608|Primary|Evaluate Immune Reconstitution|Evaluate immune reconstitution based on time to engraftment|3 months after treatment and annually|No data were collected or analyzed due to study termination|||||
175571|NCT00075608|Primary|Response and Durability of Response|Response and durability of response will be based on hematologic Complete Response or Partial Response and date of relapse or death|3 months after treatment and annually|No data were collected or analyzed due to study termination|||||
175572|NCT00075608|Primary|Feasibility and Tolerability|Feasibility and tolerability will be evaluated based on participants completing second transplant with tolerable adverse events|3 months after treatment and annually|No data were collected or analyzed due to study termination|||||
175573|NCT00075582|Secondary|Rate of Local Failure for Patients With Clinical Group III Disease When the Radiotherapy Dose is Reduced After Second-look Surgical Resection.|The local failure rate will be estimated using cumulative incidence curves.|Up to 20 weeks||||||
175574|NCT00075582|Secondary|Rate of Second-look Surgery and the Proportion of Patients Who Are Tumor-free or With Microscopic Tumor Only Following Second-look Surgeries|The decision to perform second-look surgery should be based on the physical examination and imaging studies at Week 12 and should only be considered if a reasonable functional and cosmetic result is anticipated.|At 13 weeks||||||
175575|NCT00075582|Secondary|Rate of Local Failure for Patients Who Receive Reduced Doses of Radiation Therapy|The local failure rate will be estimated using cumulative incidence curves.|Up to 10 years||||||
175576|NCT00075582|Primary|Estimated Percentage of Patients With Low-risk Rhabdomyosarcoma Treated With Regimen 2 Therapy Failure Free at 5 Years (95% Confidence Interval).|Failure free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.|5 years from study enrollment|All eligible patients among this subset of regimen 2 patients were included in this outcome measure to regimen 2 patients (there were 16 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.||Estimated percentage of participants||95% Confidence Interval|Number
175577|NCT00075582|Primary|Estimated Percentage of Patients With Stage 1, Clinical Group IIB or C (Node Positive) or Stage 2 Group I or Stage 2 Group II Disease Treated With Regimen 1 Failure-free at 5 Years|Failure-free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.|5 years from study enrollment|All eligible patients among this subset of regimen 1 patients were included in this outcome measure restricted to regimen 1 patients (there were 36 patients determined ineligible). Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome measures.||Estimated percentage of participants||95% Confidence Interval|Number
175578|NCT00075582|Primary|Estimated Percentage of Patients Failure Free at 5 Years (95% Confidence Interval)|Failure-free survival: Time to disease recurrence or death as a first event. An analysis plan based on the method of Woolson (1981) will be used to monitor outcome for these patients.|5 years from study enrollment|Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.||Estimated percentage of participants||95% Confidence Interval|Number
175579|NCT00075504|Secondary|Overall Survival||Up to 2 years|||months||95% Confidence Interval|Median
175580|NCT00075504|Secondary|Progression Free Survival|PFS will be measured from the time of the patient’s initial best response (PR or CR) until documented progression.|Up to 2 years|||months||95% Confidence Interval|Median
175581|NCT00075504|Primary|Response Rate According to RECIST Criteria|Tumor response was assessed every eight weeks by CT scan using RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR+PR.|Up to 2 years|||participants|||Number
175582|NCT00075478|Secondary|Progression-free Survival|Percentage of patients with progression-free survival, estimated by cumulative incidence methods|3 years after transplant|||percentage of participants|||Number
175583|NCT00075478|Secondary|Incidence of Graft Rejection|Donor CD3 chimerism less than 5%|1 year after transplant|||participants|||Number
175584|NCT00075478|Secondary|Incidence of Chronic Extensive GVHD|Percentage patients with chronic extensive GVHD, estimated by cumulative incidence methods|3 years after transplant|||percentage of participants|||Number
175585|NCT00075478|Secondary|Incidence of Grades II-IV Acute GVHD|Percentage patients with grades II-IV GHVD, estimated by cumulative incidence methods|120 days after transplant|||percentage of participants|||Number
175586|NCT00075478|Secondary|Incidence of Relapse-related Mortality|Percentage of death following relapse/progression, estimated by cumulative incidence methods|3 years after transplant|||percentage of participants|||Number
175587|NCT00075478|Secondary|Incidence of Relapse/Progression|Percentage of relapse estimated by cumulative incidence methods|3 years after transplant|||percentage of participants|||Number
175588|NCT00075478|Secondary|Incidence of Non-relapse Mortality|Percentage of NRM as estimated by cumulative incidence methods with competing risks|3 years after transplant|||percentage of participants|||Number
175589|NCT00075478|Primary|Overall Survival|Percentage of patients surviving as estimated by Kaplan-Meier.|3 years after transplant|||percentage of participants|||Number
175590|NCT00075218|Secondary|Change From Baseline in EQ-5D Health State Profile Index|Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.|Day 1 & 28 of each cycle : duration of double-blind treatment phase|ITT Population. Number subjects with evaluable data: (n=sunitinib, placebo)||score on scale||Full Range|Median
175591|NCT00075218|Secondary|Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)|Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated “thermometer,” indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.|Day 1 & 28 of each cycle : duration of double-blind treatment phase|ITT population. Number subjects with evaluable data: (n=sunitinib, placebo)||score on scale||Full Range|Median
175592|NCT00075218|Secondary|Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)|MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by >= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use >= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use >= 50% over baseline.|Day 1 & 28 of each cycle : duration of double-blind treatment phase|Pain-Relief-Response population.||participants|||Number
175593|NCT00075218|Secondary|Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)|25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use >= 50% over baseline OR b) Increase score >= 1 point with either NC in total analgesic use or increase total analgesic use >= 50% over baseline. (50th Quartile not achieved.)|Day 1 & 28 of each cycle : duration of double-blind treatment phase|Pain-Relief-Response population. Subjects at 25th Quartile with pain progress during blinded phase.||weeks (25th Quartile)||95% Confidence Interval|Median
175594|NCT00075218|Primary|Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study|Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).|Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)|From the Intent to Treat (ITT) population, 91 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 73 subjects on placebo were observed to have disease progression during blinded phase.||weeks||95% Confidence Interval|Median
175595|NCT00075218|Secondary|Duration of Performance Status Maintenance|Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.|Day 28 of each cycle : duration of double-blind treatment phase|ITT Population. Number of subjects at median observed to have status worsening or died before status worsening.||weeks||95% Confidence Interval|Median
175596|NCT00075218|Secondary|Time to Tumor Response (TTR)|Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.|Day 28 of each cycle : duration of double-blind treatment phase|ITT population. Number of subjects analyzed = number of subjects with tumor response.||weeks||95% Confidence Interval|Median
175597|NCT00075218|Secondary|Confirmed Objective Response (CR or PR) in Subjects|Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.|Day 28 of each cycle : duration of double-blind treatment phase|ITT population.||participants|||Number
175598|NCT00075218|Secondary|Best Overall Tumor Response During Double-blind Treatment Phase|Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).|Day 28 of each cycle : duration of double-blind treatment phase|ITT population||participants|||Number
175599|NCT00075218|Secondary|Overall Survival Based on the Rank Preserving Structural Failure Time Method|time from date of randomization to date of death due to any cause (rank preserving structural failure time method).|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population||weeks||95% Confidence Interval|Median
175645|NCT00074165|Secondary|Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment||2 years||||||
175646|NCT00074165|Secondary|Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months||5 years||||||
175600|NCT00075218|Secondary|Overall Survival|Time from date of randomization to date of death due to any cause.|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population; Number subjects Dead = 176, 90 (sunitinib, placebo respectively). Subjects who were not known to be dead at the time the database was closed for analysis were censored on the date they were last known to be alive.||weeks||95% Confidence Interval|Median
175601|NCT00075218|Secondary|Overall Survival Status of Subjects|Number of subjects alive at end of study.|clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug|ITT population.||participants|||Number
175602|NCT00075218|Secondary|Progression Free Survival (PFS)|Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).|Day 28 of each cycle : duration of double-blind treatment phase|ITT population||weeks||95% Confidence Interval|Median
175603|NCT00075218|Primary|Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase|Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).|Day 28 of each 6-week cycle : duration of double-blind treatment phase|From the Intent to Treat (ITT) population, 82 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 67 subjects on placebo were observed to have disease progression during blinded phase.||weeks||95% Confidence Interval|Median
175604|NCT00075088|Secondary|Rehospitalization and Mortality||4 years|we did not have the resources to achieve this secondary aim that required long-term follow up (a labor intensive job). The PI is now retired.|||||
175605|NCT00075088|Primary|Hospital Time to Treatment for Patients With ST-elevation Myocardial Infarction (STEMI)|Mean door-to-balloon time|Day 1|42 patients with STEMI who received primary percutaneous coronary intervention||minutes||Standard Deviation|Mean
175606|NCT00075088|Primary|Hospital Time to Treatment for Patients With Unstable Angina/Non-STEMI|Time from ED arrival to first drug was determined as recommended by American College of Cardiology/American Heart Association 2007 guidelines for management of patients with unstable angina/non-STEMI|Day 1|Patients with unstable angina/non-STEMI. Four patients with Do Not Resuscitate (DNR) orders were excluded from this time-to-treatment analysis||minutes||Standard Deviation|Mean
175607|NCT00075023|Primary|Mean Percentage Change in Total Surface Area of Oral Ulceration.|Mean percentage change in total surface area of oral ulceration|baseline to 4 weeks|||percentage change||Standard Deviation|Mean
175608|NCT00074984|Secondary|Neuropathic Pain as Assessed by Question 12 of the Brief Pain Inventory (BPI) Questionnaire (Pain at Its Worst)|Neuropathic pain was assessed by Question 12 of the Brief Pain Inventory (BPI) Questionnaire on a scale of 0 (no pain) to 10 (pain as bad as you can imagine)|at 24 months|Intent-to-treat population||units on a scale||Standard Deviation|Mean
175609|NCT00074984|Secondary|Slope of Inverse Serum Creatinine Values Comparing Placebo vs Fabrazyme (Agalsidase Beta)Patients|Summary of slopes of inverse serum creatinine by baseline serum creatinine subgroups (> or <= 1.5 mg/dL) comparing Placebo vs Fabrazyme (agalsidase beta) patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.||dL/mg/year||Standard Deviation|Mean
175610|NCT00074984|Secondary|Slope of Estimated Glomerular Filtration Rate (eGFR) Comparing Placebo vs Fabrazyme (Agalsidase Beta) Patients|Summary of slopes of eGFR by baseline eGFR subgroups (>60 and <=60 mL/min/1.73m^2/year) comparing Placebo vs Fabrazyme (agalsidase beta) Patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication||mL/min/1.73m^2/year||Standard Deviation|Mean
175611|NCT00074984|Secondary|Number of Participants Experiencing a Renal Event in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients|Time to a clinically significant renal event (33% increase in serum creatinine, dialysis or transplant) in Fabrazyme (agalsidase beta) patients as compared to placebo patients.|up to 35 months|The Intent-to-treat population consisted of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.||participants|||Number
175612|NCT00074984|Primary|Number of Participants Experiencing a Clinically Significant Renal, Cardiac or Cerebrovascular Event and/or Death in Fabrazyme (Agalsidase Beta) Patients as Compared to Placebo Patients|The primary efficacy endpoint was the time to the first occurrence of a clinically significant renal (33% increase in serum creatinine, dialysis or transplant), cardiac (myocardial infarction, significant change in cardiac status, i.e., angina, congestive heart failure or symptomatic arrhythmia requiring medication or surgery) or cerebrovascular (stroke or transient ischemic attack) event and/or death (due to any cause) in Fabrazyme (agalsidase beta) patients as compared to placebo patients.|up to 35 months|The Intent-to-treat (ITT) population consists of all 82 patients who were randomized, enrolled, and received at least one infusion of study medication.||participants|||Number
175613|NCT00074958|Secondary|Plasma GL-3|Plasma GL-3 values at Baseline, Week 24, and Week 48. Normal plasma GL-3 level is ≤ 7.03 µg/mL.|Baseline, Week 24 and Week 48|ITT population. 16 male patients had plasma GL-3 values at Baseline and Week 24, while 15 male patients had plasma GL-3 values at Week 48. 2 female patients had plasma GL-3 values at Baseline, Week 24 and Week 48.||µg/mL||Standard Deviation|Mean
175614|NCT00074958|Primary|Globotriaosylceramide (GL-3) Clearance in Capillary Endothelium in the Skin|Skin biopsies were taken at Baseline, Week 24 and Week 48 and analyzed for cellular GL-3 accumulation (inclusions) by light microscopy. Each biopsy was evaluated by pathologists for the total number of vessels with GL-3 accumulation on an inclusion severity score of 0 (none/trace), 1 (mild), 2 (moderate), and 3 (severe).|Baseline, Week 24 and Week 48|Intent to Treat (ITT) population – male patients only. 14 patients had skin biopsies performed at Baseline and Week 24 but only 5 patients had skin biopsies performed at Week 48.||patients|||Number
175615|NCT00074815|Secondary|Pediatric Adverse Event Rating Scale (PAERS)||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up||||||
175616|NCT00074815|Secondary|Child Depression Inventory||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up||||||
175617|NCT00074815|Secondary|Child Obsessive -Compulsive Impact Scale (COIS)||Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up||||||
175647|NCT00074165|Secondary|Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression||5 years||||||
175618|NCT00074815|Primary|Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)|"OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 – 20), and a composite symptom severity score (0 to 40).~Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure."|Measured at baseline and Week 12.|Intent to treat (all included)||Proportion of Participants with RESPONSE||95% Confidence Interval|Number
175619|NCT00074711|Secondary|Change From Baseline in Urinary Hydroxyproline to Creatinine Ratio at 12 Months||Measured at baseline and 12 months|||micromol/mmol||Standard Error|Mean
175620|NCT00074711|Secondary|Change From Baseline in Urinary N-telopeptide at 12 Months||Measured at baseline and 12 months|||nmol bce/mmol||Standard Error|Mean
175621|NCT00074711|Secondary|Change From Baseline in Urinary Calcium to Creatinine Ratio, Urinary Phosphorus to Creatinine Ratio at 12 Months||Measured at baseline and 12 months|||g/g||Standard Error|Mean
175622|NCT00074711|Secondary|Change From Baseline in Serum Phosphorus, Serum Creatinine, Serum Calcium at 12 Months||Measured at baseline and 12 months|||mg/dl||Standard Error|Mean
175623|NCT00074711|Primary|Bone Mineral Density (BMD) Under Treatment With an Anabolic Agent (Teriparatide).|The principle outcome measure was change in bone mineral density (BMD) under treatment with an anabolic agent (teriparatide).|12 months|Participants that completed study.||g/cm2||Standard Error|Mean
175624|NCT00074711|Primary|Lumbar Spine and Hip BMD, Measured as Grams Per Square Centimeter.|Bone mineral density (BMD, measured by dual X-ray absorptiometry – DEXA) measured at several intervals during the study. BMD measured as grams per square centimeter (g/cm2).|Measured at Baseline|Postmenopausal women with spinal osteoporosis.||g/cm2||Standard Deviation|Mean
175625|NCT00074581|Primary|All Partner HIV Infection Rates in Early-ART and Delayed-ART Arms|All Incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm.|Throughout study|Population includes all partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases, by arm.||event rate per 100 person-yr||95% Confidence Interval|Number
175626|NCT00074581|Primary|Linked Partner HIV Infection Rates in Early-ART and Delayed-ART Arms|incident HIV infections occurring in the partners (HIV-negative at enrollment) of randomized HIV-infected index (HIV-positive at enrollment) cases are assessed, by arm. Only acquisition from the index partner were included in the primary analysis, therefore, each endpoint was required to be confirmed (by genotyping) such that the viral envelop sequence in the index case matched that of the partner.|Throughout study|||event rate per 100 person-yr|Person Years|95% Confidence Interval|Number
175627|NCT00074412|Secondary|NVP Concentrations in Infants Determined to be HIV-infected and in a Sample of HIV-uninfected Infants|Samples for NVP concentration were selected from the Version 3.0 infants who were randomized to NVP at 6 weeks and whose mothers were not on 3 or more antiretrovirals at the time of randomization. All infants HIV-infected by 6 months who met this criteria were selected and matched to HIV-uninfected infants who also met this criteria in a 1:3 ratio. NVP concentrations were measured by high liquid chromatographic/mass spectroscopy from the aforementioned infants plasma samples collected at week 8 and month 3. Median NVP concentrations were compared|Week 8 and Month 3||||||
175628|NCT00074412|Secondary|Rates of Disease Progression as Defined by CD4 Counts, HIV-1 RNA PCR, and Mortality in Infected Infants in the Two Arms||Throughout study||||||
175629|NCT00074412|Secondary|Frequency and Duration of NVP-resistant HIV Strains in Plasma of HIV-infected Infants||Throughout study||||||
175630|NCT00074412|Secondary|Relationship Between Maternal Plasma and Breast Milk RNA Levels and the Risk of MTCT||Throughout study||||||
175631|NCT00074412|Secondary|Frequency and Duration of Maternal Plasma and Breast Milk NVP-resistant HIV Strains and the Relationship With HIV Transmission||Throughout study||||||
175632|NCT00074412|Secondary|Infant Survival Rates (Mortality Regardless of HIV Infection) in the Two Arms||At Month 18|||participants|||Number
175633|NCT00074412|Secondary|Relative Rates of HIV Infection in the Two Arms||At Month 18|A total of 1527 infants were randomized to either placebo or extended NVP. 5 of these infants were later found to be infected at the time of randomization (2 in NVP and 3 in Placebo). Thus, only 1522 infants were included in the analysis.||participants|||Number
175634|NCT00074412|Secondary|Proportion of Infants Who Are Alive and HIV-uninfected in the Two Arms||At Months 6 and 18|There were 1522 infants randomized at 6 weeks of birth to either the extended Nevirapine arm (759) or the placebo arm (763).||participants|||Number
175635|NCT00074412|Primary|Frequency and Severity of Adverse Reactions Among Participating Infants|For those infants who were randomized at 6 weeks and who initiated study drug we looked at the frequency and severity of adverse reactions through 18 months of study. The severity of all AEs was graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. The term severity is described as the intensity grade or level for specific event (i.e. mild, moderate, severe, or life-threatening). Severity is not the same as seriousness.|6 weeks through 18 months|A total of 1519 infants, 758 in the NVP arm and 761 in the placebo arm, initiated study product and were thus included in the analysis for the frequency and severity of adverse reactions.||Number of Adverse Events|Participants||Number
175636|NCT00074412|Primary|HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study||At Month 6|All infants who were randomly allocated to either treatment or placebo at 6 weeks of age under version 3.0 of the protocol were included in the analysis of the primary endpoint, HIV infection at 6 months. 127/1700 infants were enrolled but excluded from randomization at 6 weeks for various reasons as mentioned in the flow-through.||participants|||Number
175637|NCT00074269|Secondary|Frequency and Durability of the Induction of Full Donor Chimerism of Lymphocytes as Measured at 1, 3, 6, and 12 Months Post Allografting||post treatment||||||
175638|NCT00074269|Secondary|Response (Partial and Complete) as Measured at 1, 3, 6, and 12 Months Post Allografting and Within 1 Week After the Onset of Documented GVHD if > 1 Month Separates Any of the Response Evaluation Timepoints||post treatment||||||
175639|NCT00074269|Secondary|Overall Survival||post treatment||||||
175640|NCT00074269|Secondary|Progression-free Survival||post treatment||||||
175648|NCT00074165|Secondary|Number of Participants With Overall Survival Assessed by Clinical and Radiographic Response|Overall survival is measured from entry onto study until death from any cause or until death or progression of disease, respectively.|5 years|Inadequate sample size to determine overall survival||participants|||Number
175649|NCT00074165|Primary|Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.|Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.|2 years|||Participants|||Number
175650|NCT00074152|Secondary|Sites of First Failures|Tumor recurrence in the breast, lymph nodes or other areas of the body including bone, lung, liver, central nervous system, bone marrow|5 years after randomization|||participants|||Number
175651|NCT00074152|Secondary|Overall Survival||5 years after randomization|||percentage of participants||95% Confidence Interval|Number
175652|NCT00074152|Primary|Disease-free Survival||5 years after randomization|||percentage of participants||95% Confidence Interval|Number
175653|NCT00073983|Secondary|Pharmacokinetics of Gemcitabine Alone and Gemcitabine Followed by Docetaxel at Protocol Specified Timeframe in Participants Enrolled on Study|Blood samples for the determination of gemcitabine (and its metabolite dFdU) will be obtained prior to infusion, at 75 and 85 minutes (steady state), and 95 105 and 120 minutes, after the start of the 90 minute infusion on day 1 and day 8 of cycle 1. On day 8, docetaxel pharmacokinetics will be performed prior to infusion, 55 minutes (5 minutes prior to the end of infusion), 30 minutes post infusion, 5 hr and 24hr post infusion.|Gemcitibine: 0hr, 75, 85, 95, 105 and 120 min after the start of the 90 minute infusion; docetaxel: 0hr, 55 min, 30 min post infusion, 5hr and 24hr post infusion.|There were insufficent samples obtained to analyze pharmacokinetics.||participants|||Number
175654|NCT00073983|Secondary|Toxicity as Assessed by NCI CTCAE v3.0|Toxicity was graded according to Common Terminology Criteria for Adverse Events v.3.0 (CTCAE v.3.0). For gemcitabine or docetaxel related grade 3 or 4 non-hematological toxicities or hematological toxicities (grade 3 or 4 neutropenia for ≥ 7 days, grade 4 thrombocytopenia, or any platelet transfusion), both agents were withheld until the toxicity was ≤ grade 1. If the toxicity recovered to ≤ grade 1 by cycle day 35, the dose of both agents was reduced for all subsequent cycles. If the toxicity did not resolve by day 35, protocol therapy was discontinued.|Throughout the study|Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.||participants|||Number
175655|NCT00073983|Secondary|Time to Progression|Stable disease is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started. The clinical relevance of the duration of stable disease varies for different tumor types and grades. Bayesian statistical model is used. Timepoints for evaluation are post-cycle 2, 4, 8 and 12 using RECIST 1.0 criteria.|post-cycle 2, 4, 8 and 12|Analysis not completed. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.||months|||Number
175656|NCT00073983|Primary|Objective Response Rate|Patients will be evaluated up to 4 time points(after 2,4,8 and 12 cycles of therapy), each cycle is 21 days. Per RECIST 1.0 and assessed by CT/MRI disease status will be categorized as R=CR/PR(response), F=progressive disease or death(failure), or S(stable disease=neither R nor F) based on the change from baseline. A patient with outcome R or F at any stage is scored as having that overall outcome, a patient with outcome S is re-evaluated after subsequent cycles of therapy. Patients who receive more than 14 cycles of therapy will be scored as the outcome at completion of cycle 14.|After 2, 4, 8 and 12 cycles of therapy, each cycle is 21 days|Analysis per protocol. One patient with chondrosarcoma was ineligible due to lack of measurable disease at enrollment.||participants|||Number
175657|NCT00073918|Secondary|Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0|All patients, regardless of histology, will be evaluated together for purposes of toxicity. Sufficient evidence will be taken to be a lower limit to the appropriate 90% one-sided confidence interval in excess of 25%,, where these limits are estimated after every 10th patient is enrolled and followed sufficiently long to evaluate toxicity.|From date of first exposure to study drug, through date of relapse/progression or other significant medical event confounding further assessment, assessed up to 15 years||||||
175658|NCT00073918|Secondary|Response Rate|Response rates will be estimated as simple proportions. Associated confidence intervals will be provided as part of the analysis.|From date of transplant through date of relapse/progression or death, assessed up to 15 years||||||
175659|NCT00073918|Secondary|5 Year Overall Survival|Survival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis.|Up to 15 years|||percentage of participants surviving|||Number
175660|NCT00073918|Primary|Progression-free Survival|Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.|At year 3|||percentage of participants PFS|||Number
175661|NCT00073528|Secondary|Number of Participants With the Indicated Expression of Tumor by Epidermal Growth Factor Receptor (ErbB1/HER1/EGFR) at Baseline|EGFR is a cell surface receptor tyrosine kinase expressed in certain types of tumors. Depending upon the staining intensity, EGFR was graded as follows: 0=absence of membrane staining above background in all tumor cells; EGFR-positive=staining is defined as any IHC staining of tumor cell membranes above background level, whether it is complete or incomplete circumferential staining (1+, 2+, 3+).|Baseline|ITT Population||participants|||Number
175662|NCT00073528|Secondary|Time to Seroconversion for Participants Who Were HER2 Negative at Baseline But Became HER2 Positive|Time to seroconversion was defined as the time from the date of randomization until the first instance of serum HER2 (>15 ng/mL) on two consecutive occasions.|Up to 46 months|HER2-Negative Population. Only those participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL were assessed.||weeks||95% Confidence Interval|Median
175663|NCT00073528|Secondary|Number of HER2-Negative Participants at Baseline With and Without Seroconversion to a Status of HER2 Positive|Participants who had a HER2-negative tumor status based on baseline tissue with baseline serum HER2 ECD values =<15 ng/mL but later had at least two consecutive serum HER2 ECD values >15 ng/mL experienced seroconversion.|Up to 46 months|HER2-Negative Population: all randomized participants regardless of whether or not study treatment had been received and who at baseline were evaluated by the central laboratory to have retrospectively documented non-amplification or missing amplification of HER2 by FISH (<2.0) and documented IHC scores of 0, 1+, 2+, or missing in tumor tissue.||participants|||Number
175664|NCT00073528|Secondary|Number of Participants With Response in Participants With Baseline Serum HER2 Extracellular Domain (ECD) Baseline Values Greater Than 15 Nanograms Per Milliliter (ng/mL) and 15 ng/mL or Lower|The HER2 ECD is a glycoprotein that can be shed from the cell surface into the blood of normal individuals and can be elevated in different pathologic conditions. The serum HER2 ECD level generally reflects the tissue HER2 status. The HER2 ECD is quantified in serum with an enzyme-linked immunosorbent assay (ELISA). Non-Evaluable (NE): any participant who could not be classified as CR, PR, SD, or PD.|Up to 46 months|HER2-Positive Population||participants|||Number
175665|NCT00073528|Secondary|Number of Participants With Clinical Benefit Categorized by HER2 ImmunoHistoChemistry (IHC) Intensity|IHC is a commonly used test to assess the amount of the HER2 receptor protein on the surface of the cancer cells. The IHC test results in a score of 0 to 3+, which indicates the amount of HER2 receptor protein on the cells in a sample of breast cancer tissue. Tissue scores of 0 to 1+ indicate HER2 negativity; scores of 2+ and 3+ indicate HER2 positivity. Clinical benefit is defined as participants with CR, PR, or SD for =>6-month period.|Up to 46 months|ITT Population||participants|||Number
175666|NCT00073528|Secondary|Number of Participants With Clinical Benefit Categorized by HER2 Fluorescence in Situ Hybridization (FISH) Status|Clinical benefit: participants with CR, PR, or SD for =>6-month period. FISH testing measures the amount of the HER2 gene in each cell. This gene is responsible for the overproduction of the HER2 protein. FISH-positive: excessive amounts of the gene are present; FISH-negative: normal levels of the gene are present.|Up to 46 months|ITT Population||participants|||Number
175667|NCT00073528|Secondary|Number of Participants Classified as QOL Responders Based on the FACT-B, FACT-G, and TOI Total Scores|A minimally important difference (MID) is the smallest difference in a score for a measure of QOL that corresponds to a difference in function or clinical course. Responders are defined as participants with an MID => 8 for the FACT-B score, and an MID =>6 for the FACT-G and TOI scores.|Up to 46 months|HER2-Positive Population. Only those participants with a baseline score and at least one post-baseline score were assessed.||participants|||Number
175668|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the Trial Outcome Index (TOI) Score Using Observed Data|The TOI score is the sum of the physical well-being, functional well-being, and breast cancer unweighted subscale scores. The total TOI score ranges from 0 to 92, with higher scores representing a better quality of life.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.||scores on a scale||Standard Error|Mean
175669|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the Functional Assessment of Cancer Therapy-General (FACT-G) Score Using Observed Data|FACT-G is a subscale of the FACT-B QOL questionnaire and consists of 27 questions grouped into 4 domains that measure a participant's physical, functional, social and family, and emotional well-being. FACT-G is assessed on a five-point Likert-type scale, with scores ranging from 0 to 4 (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total score is calculated as the sum of the item scores on the subscale; the total ranges from 0 to 108, with higher score indicating a better quality of life.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.||scores on a scale||Standard Error|Mean
175670|NCT00073528|Secondary|Adjusted Mean Change From Baseline for the FACT-B Total Score Using Observed Data|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which is a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144. The FACT-B is designed to measure multidimensional QOL in participants with breast cancer.|Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit|HER2-Positive Population. Only those participants whose item response rate was greater than 80% were assessed.||scores on a scale||Standard Error|Mean
175671|NCT00073528|Secondary|Number of Participants Completing the Functional Assessment of Cancer Therapy-breast (FACT-B) Questionnaire at the Scheduled Visits|Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales (each ranging from 0 [not at all] to 4 [very much]) indicate a higher QOL. The score is transformed for FACT-B and results in a total score ranging from 0 to 144. Complete: completing at least 1 question from FACT-B.|Day 1 (baseline) visit; Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 visits; conclusion/withdrawal visit|ITT Population||participants|||Number
175672|NCT00073528|Secondary|Number of Participants With the Indicated Serious Adverse Events (SAEs) Related to Study Drug Reported by More Than One Participant in Either Treatment Arm|An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the Investigator's medical judgement.|Up to 46 months|Safety Population. Only those participants who experienced SAEs related to study drug that were reported by more than one participant in either treatment arm were assessed.||participants|||Number
175673|NCT00073528|Secondary|Number of Participants With the Indicated Adverse Events (AEs) Related to Study Treatment Reported in 10% or More Participants in Either Treatment Arm|An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the AE was possibly or probably related to study treatment.|Up to 46 months|Safety Population: all randomized participants who had received at least 1 dose of study treatment, based on the actual treatment received if this differed from that to which the participant was randomized. All participants with any AE related to study treatment were assessed.||participants|||Number
175707|NCT00073073|Secondary|Effect of This Drug on Breast Tissue Trefoil Factor 1 and Proliferating Cell Nuclear Antigen Expression, Prolactin, and Breast Tissue Prolactin Receptor at 1 Year||1 year|Change in breast tissue trefoil factor 1||percent change from baseline||95% Confidence Interval|Mean
175674|NCT00073528|Secondary|TTP for Participants From the ITT Population as Assessed by the Investigator|TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.|Up to 46 months|ITT Population. Only those participants who experienced disease progression or died due to breast cancer were assessed.||weeks||95% Confidence Interval|Median
175675|NCT00073528|Secondary|Number of Participants With Evidence of Brain Metastases From the ITT Population|The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.|Up to 46 months|ITT Population||participants|||Number
175676|NCT00073528|Secondary|Duration of Response for the Participants With CR or PR in the ITT Population as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|ITT Population. Only those participants with CR or PR response were assessed.||weeks||Inter-Quartile Range|Median
175677|NCT00073528|Secondary|Number of Participants With the Indicated Time to Response for CR or PR in the ITT Population as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|ITT Population. Only those participants with CR or PR were assessed.||participants|||Number
175678|NCT00073528|Secondary|Clinical Benefit (CB) in the ITT Population as Assessed by the Investigator|CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.|Up to 46 months|ITT Population||percentage of participants|||Number
175679|NCT00073528|Secondary|Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator|Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT and the randomization date.|Up to 46 months|ITT Population. Only those participants with some measurable disease were assessed. Response with bone scan confirmation was required. Participants with bone-only disease were excluded from the analysis because bone-only disease is non-measurable only per RECIST 1.0.||participants|||Number
175680|NCT00073528|Secondary|Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator|OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Up to 46 months|ITT Population. Only those participants who achieved either a confirmed CR or PR were assessed.||percentage of participants|||Number
175681|NCT00073528|Secondary|Overall Survival in the ITT Population|Overall survival was defined as the time from randomization until death due to any cause.|From date of randomization until date of death due to any cause, assessed up to 46 months|ITT Population. Only those participants who died during the study due to any cause were assessed.||weeks||95% Confidence Interval|Median
175682|NCT00073528|Secondary|Time to Progression (TTP) for the HER2-Positive Population as Assessed by the Investigator|TTP is defined as the interval between the date of randomization and the earliest date of disease progression or death due to breast cancer. Disease progression was based on the assessments by the Investigator.|Up to 46 months|HER2-Positive Population. Only those participants who experienced disease progression or died due to breast cancer were assessed.||weeks||95% Confidence Interval|Median
175683|NCT00073528|Secondary|Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population|The confirmation criteria for the evidence of brain metastases was the incidence of lesions occurring within any part of the central nervous system (CNS) as evidenced by radiological scans. Metastases are defined as the spread of cancer from one part of the body to another.|Up to 46 months|HER2-Positive Population||participants|||Number
175684|NCT00073528|Secondary|Duration of Response for the Participants With CR or PR in the HER2-Positive Population as Assessed by the Investigator|Duration of response is defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD) until the first documented sign of disease progression or death due to any cause. The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|HER2-Positive Population. Only those participants with CR or PR were assessed.||weeks||Inter-Quartile Range|Median
175685|NCT00073528|Secondary|Number of Participants With the Indicated Time to Response for CR or PR in the HER2-Positive Population as Assessed by the Investigator|Time to response is defined as the time from randomization until the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sume of the LD of target lesions, taking as reference the baseline sum LD) (whichever status was recorded first). The assessments of CR or PR required confirmation using bone scans.|Up to 46 months|HER2-Positive Population. Only those participants with CR or PR were assessed.||participants|||Number
175708|NCT00073073|Secondary|Absolute Change of Lipid Profiles on Exemestane From Baseline||1 year|Change in total cholesterol||mg/dl||Standard Deviation|Mean
175686|NCT00073528|Secondary|Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator.|CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.|Up to 46 months|ITT Population||participants|||Number
175687|NCT00073528|Secondary|Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator.|CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as a reference the smallest sum LD since the baseline measurement. The best overall response is defined as the best response recorded from the start of treatment until disease progression/recurrence. PD: presence of target lesions, non-target lesions, and/or new lesions.|Up to 46 months|HER2-Positive Population||participants|||Number
175688|NCT00073528|Secondary|Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator|CB is defined as the percentage of participants with evidence of confirmed CR, PR, or stable disease (SD) for at least 6 months. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the baseline measurement.|Up to 46 months|HER2-Positive Population||percentage of participants|||Number
175689|NCT00073528|Secondary|Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator|Participants were stratified based on site of disease at screening (SDS) (soft tissue or visceral or bone-only disease) and prior adjuvant endocrine therapy (PAET) (discontinuation interval [DI] =>6 months or DI <6 months). OR is defined as the number of participants achieving either a confirmed CR or PR. Response was assessed via RECIST. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the baseline sum LD. DI is defined as the time period from stopping the PEAT to the randomization date.|Up to 46 months|HER2-Positive Population. Only those participants with measurable disease, including bone scans, were assessed.||participants|||Number
175690|NCT00073528|Secondary|Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator|OR is defined as the percentage of participants achieving either a confirmed complete response (CR) or partial response (PR). Response was assessed via Response Evaluation criteria in Solid Tumors (RECIST). The percentage of participants with response was calculated by using the formula: 100 * (number of participants with CR + number of participants with PR)/total number of participants. CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD.|Up to 46 months|HER2-Positive Population||percentage of participants|||Number
175691|NCT00073528|Secondary|Overall Survival in the HER2-Positive Population|Overall survival was defined as the time from randomization until death due to any cause.|From date of randomization until date of death due to any cause, assessed up to 46 months|HER2-Positive Population. Only those participants who died during the study due to any cause were assessed.||weeks||95% Confidence Interval|Median
175692|NCT00073528|Secondary|PFS in Participants in the ITT Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|ITT Population. Only those participants who experienced disease progression or died during their participation in the study were assessed.||weeks||95% Confidence Interval|Median
175693|NCT00073528|Secondary|Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|ITT Population: all randomized participants, regardless of whether or not study treatment had been received. The ITT Population included the HER2-Positive Population, the HER2-Negative Population, and the HER2-Missing Population.||participants|||Number
175694|NCT00073528|Primary|Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression or death due to any cause, if sooner. The date of documented disease progression is defined as the date of radiological disease progression as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per RECIST 1.0, disease progression is defined as a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months|HER2-Positive Population. Only those participants who experienced disease progression or died during their participation in the study were assessed.||weeks||95% Confidence Interval|Median
175695|NCT00073528|Primary|Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Her3 as Assessed by the Investigator|PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. The date of documented PD is defined as the date of radiological PD as assessed by the investigator based on imaging data and also by the clinical assessment of symptomatic progression. Per Response Evaluation Criteria in Solid Tumors (RECIST 1.0), PD is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.|From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months|HER2-Positive Population: all randomized participants who had documented amplification of baseline HER2 by fluorescence in situ hybridization (FISH) (=>2.0) or 3+ immunohistochemistry (IHC) (or 2+ IHC and FISH +) in archived tumor tissue regardless of whether or not study treatment had been received.||participants|||Number
175696|NCT00073333|Primary|Social Phobia Remission Rate at 6 Month Follow-up|Lack of SocialPhobia Diagnosis at 6 month follow-up|6 month follow up|||participants|||Number
175697|NCT00073333|Secondary|Score on the SPAI||Measured at Month 12||||||
175698|NCT00073333|Primary|Social Phobia Remission||Measured at Month 12||||||
175699|NCT00073307|Secondary|Health-related Quality of Life (HRQOL) by Physical Well-Being (PWB) Score of the FACT-G (Functional Assessment of Cancer Therapy-General Version) Assessment|"Primary Analysis for FACT-G (using PWB score) patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FACT-G (PWB score) patient responses for each question range from 0=not at all to 4=very much and after reverse coding the total FACT-G (PWB score) range of values is from 0 to 28; higher score represents better HRQOL."|From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.|Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.||Scores on a scale||Standard Error|Least Squares Mean
175700|NCT00073307|Secondary|Health-related Quality of Life (HRQOL) by FKSI-10 (Functional Assessment of General Therapy Kidney Symptom Index 10) Assessment|"Primary Analysis for FKSI-10 patient-reported outcome (PRO) measure defined as longitudinal analysis of mean score over the first 5 treatment cycles. FKSI-10 patient responses for each question range from 0=not at all to 4=very much and after reverse coding the range of values for FKSI-10 total score is from 0 to 40; higher score represents better HRQOL."|From start of randomization of the first subject (1Dec2003) until the data cut-off (31May2005), approximately 18 months later, PRO data collected at Day 1 of each cycle and end of treatment.|Evaluations based on ITT population with a PRO assessment. Day 1, Cycle 1 served as baseline assessment.||Scores on a scale||Standard Error|Least Squares Mean
175701|NCT00073307|Secondary|Best Overall Response - Independent Radiological Review|Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.|From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.|Evaluations of best overall response based on the valid for response population, where as per protocol, subjects were to have first post-baseline tumor evaluation performed at the end of Cycle 1 (6 weeks post-randomization). Of the ITT population that met this criteria as of the 28Jan2005 data cut, 672 subjects were valid for response.||percentage of participants|||Number
175702|NCT00073307|Secondary|Final Progression-Free Survival (PFS) - Independent Radiological Review|PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.|From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.|Evaluations based on ITT population as of 28Jan2005 data cut; 769 subjects randomized at that time. PFS determined as time from randomization to actual date of disease progression (PD) (radiological or clinical) or death, if death occurred before PD. Subjects without PD or death at time of analysis were censored at last date of tumor assessment.||days||95% Confidence Interval|Median
175703|NCT00073307|Primary|Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.|From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later|Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of FU (last visit or contact or at data cut-off date). In case of incomplete date, missing day, day 15 was used. Placebo censored at 30June2005, approximate time of crossover of placebo subjects to sorafenib. NA - not estimable due to censored data.||days||95% Confidence Interval|Median
175704|NCT00073307|Primary|Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population|Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.|From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later|Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of follow-up (FU) (last visit or contact or at data cut-off date). In case of incomplete date, day was missing, day 15 was used.||days||95% Confidence Interval|Median
175705|NCT00073073|Secondary|Number of Serum and Breast Tissue Samples Collected for Exploratory Proteomic Profiles at One Year||1 year|Outcome not measured|||||
175706|NCT00073073|Secondary|Effect of Exemestane on Autocrine Prolactin and Breast Tissue Prolactin Receptor at One Year||1 year|Outcome not measured|||||
175713|NCT00073021|Secondary|Percentage of Treatment Success Patients at Week 3, ITT Population|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|3 Weeks|ITT Patients with Moderate Disease [PGA = 2] at Baseline||Percentage of Participants|||Number
175714|NCT00073021|Secondary|Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|6 Weeks|All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Left Sided Disease = proctitis, proctosigmoiditis or left-sided colitis||Percentage of Participants|||Number
175715|NCT00073021|Secondary|Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients|IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32-224 - higher score better.|6 Weeks|All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social.||Scores on a Scale||Standard Error|Mean
175716|NCT00073021|Secondary|Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients|IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32 - 224 - higher score better.|3 Weeks|All Randomized Patients with Moderate Disease[PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social.||Scores on a Scale||Standard Error|Mean
175717|NCT00073021|Secondary|Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6|PGA -Physician's Global Assessment - 0=quiescent disease (all parameters 0), 1=mild disease (parameters mostly 1's) 2=moderate (parameters mostly 2's), 3=severe (parameters mostly 3's) [parameters: combination of stool frequency, rectal bleeding, PFA & sigmoidoscopy findings] If scoring equal default to physician judgement.|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline||Percentage of Participants|||Number
175718|NCT00073021|Secondary|Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6|PFA - 0=generally well, 1=fair, 2=poor, 3=terrible|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline||Percentage of Participants|||Number
175719|NCT00073021|Secondary|Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6|Rectal Bleeding (0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed)|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline||Percentage of Participants|||Number
175720|NCT00073021|Secondary|Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6|0=Normal stool frequency per day, 1=1-2 stools greater than normal per day, 2=3-4 stools greater than normal per day, 3=5 or more stools greater than normal per day|6 Weeks|ITT Patients with Moderate Disease [PGA=2] at Baseline||Percentage of Participants|||Number
175721|NCT00073021|Secondary|Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population|Sigmoidoscopy Assessment Score (0=normal intact vascular pattern, no friability or granularity, 1=mild erythema; diminished or absent vascular markings; mild granularity; friability, 2=moderate marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations, 3=severe spontaneous bleeding, ulcerations)|6 Weeks|ITT Population with Moderate Disease [PGA=2] at Baseline||Percentage of Participants|||Number
175722|NCT00073021|Secondary|Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population|Rectal Bleeding - 0=no blood seen, 1=streaks of blood w/stool less than half of the time, 2=obvious blood w/stool most of the time, 3=blood alone passed Sigmoidoscopy Assessment Score - 0=normal (intact vascular pattern, no friability or granularity), 1=mild (erythema, diminished or absent vascular markings; mild granularity; friability), 2=moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations) 3=severe (spontaneous bleeding, ulcerations)|6 Weeks|ITT Patients with Moderate Disease [PGA=2] at Baseline. Percentage of patients whose rectal bleeding AND sigmoidoscopy scores BOTH improved from baseline at Week 6||Percentage of Participants|||Number
175723|NCT00073021|Secondary|Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population|UCDAI - sum of clinical assessment scores (stool frequency score [0=normal, 1=1-2 stools > normal/day, 2=3-4 stools > normal/day, 3=5 or more stools > normal/day], rectal bleeding score [0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed and PGA score [0=quiescent disease, 1=mild, 2=moderate, 3=severe]) and sigmoidoscopy score [0=normal, 1=mild, 2=moderate, 3=severe]|6 weeks|ITT Population with Moderate Disease [PGA = 2] at Baseline.||Scores on a Scale||Standard Error|Mean
175724|NCT00073021|Primary|Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population|Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)|6 Weeks|ITT Population with Moderate Disease [PGA = 2] at Baseline||Percentage of Participants|||Number
175752|NCT00072293|Secondary|5-year Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause.|5-year estimate reported after a median follow-up of 60 months|Intention-to-treat||percentage of participants|||Number
175725|NCT00073008|Secondary|Review of Non-small Cell Lung Cancer (NSCLC) Histology (Cell Type) Using an Independent Review|Comparison of the specific cell type (histology) of non-small cell lung cancer from participant’s tissue samples, as determined by local pathologist, to the type determined by an independent pathologist. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, NSCLC histology was not analyzed.|Anytime from Baseline through end of study|||participants|||Number
175726|NCT00073008|Secondary|Overall Survival|Overall survival is measured as the time from randomization until death due to any cause. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, overall survival was not analyzed.|From randomization and then every 8 weeks while on study drug and then every 3 months as follow-up until death|||Number of weeks or months||95% Confidence Interval|Median
175727|NCT00073008|Secondary|Time to Tumor Progression|Time from randomization until the first documented sign of disease progression or death due to any cause, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to tumor progression was not analyzed.|From randomization and then every 8 weeks to disease progression or death|||Number of weeks or months||95% Confidence Interval|Median
175728|NCT00073008|Secondary|Duration of Response|For those participants who show a complete or partial response, duration of response would be time from first documented evidence of response (complete or partial response by RECIST) until disease progression or death, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, duration of response was not analyzed.|Time from first documented evidence of response to study treatment and then every 8 weeks until disease progression or death|||Number of weeks or months||95% Confidence Interval|Median
175729|NCT00073008|Secondary|Time to Response|Time from randomization until first documented evidence of partial or complete tumor response, measured using standard criteria (RECIST). Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to response was not analyzed.|From randomization and then every 8 weeks to time of response to study drug|||Number of weeks or months||95% Confidence Interval|Median
175730|NCT00073008|Secondary|Quality of Life|Standard survey forms were completed by the participant at scheduled assessments to find out how the participant felt while on study. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, quality of life was not analyzed.|Baseline and then every 4 weeks through end of treatment|||Points on a scale||Standard Deviation|Median
175731|NCT00073008|Secondary|Pharmacogenetics (PgX)|To (1) investigate the relationship between genetic variants in specific genes and the absorption, distribution, metabolism, and excretion (pharmacokinetics) of lapatinib, and to (2) investigate the relationship between genetic variants in select genes in DNA and the response (safety, efficacy, and tolerability) to lapatinib. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacogenetics were not analyzed.|From randomization at every 4-week assessment through end of treatment|||presence or absence of certain genes||Standard Deviation|Median
175732|NCT00073008|Secondary|Pharmacokinetics (PK) of Lapatinib|To characterize the PK (absorption, distribution, metabolism, and excretion) of the study drug lapatinib in the participant population. PK is defined as the concentration of drug in a participant’s blood at certain time points after the drug was taken by mouth. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacokinetics were not analyzed.|From randomization to time of PK period completed: Day 1 (first dose) and Days 2, 28, and 29 while participant was on study drug|||nanograms per millilieter (ng/mL)||Full Range|Median
175733|NCT00073008|Secondary|The Number of Participants Who Showed Certain Biomarkers in Their Serum or Tumor Tissue|To further characterize the participant population, these biomarkers could be tested: serum levels of ErbB1 and ErbB2; intra-tumoral expression of ErbB1, ErbB2, etc.; mutations in ErbB1, ErbB2, and k-ras. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, serum biomarkers were not analyzed.|From randomization to disease progression (for serum biomarkers) or until analyses of tumor tissue samples|||participants|||Number
175734|NCT00073008|Secondary|Progression-free Survival (PFS) at Four Months in the Non-Targeted Population|Percentage of participants in the Non-Targeted Population, at 4 months after starting study drug, who were alive and without disease progression.|From randomization and then every 8 weeks up to four months|Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population.||percentage of participants|||Number
175735|NCT00073008|Secondary|Progression-free Survival (PFS) at Four Months in the Targeted Population|Percentage of participants in the Targeted Population, at 4 months after starting study drug, who were alive and without disease progression.|From randomization and then every 8 weeks up to four months|Targeted Population||percentage of participants|||Number
175736|NCT00073008|Other Pre-specified|Tumor Response in the Non-Targeted Population Through the End of Treatment|Baseline and then every 8 weeks through end of treatment (end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event or participant decision)|Baseline and then every 8 weeks through end of treatment|Non-Targeted Population: all randomized participants who received at least one dose of study drug but who did not meet the criteria for inclusion in the Targeted Population.||participants|||Number
175753|NCT00072293|Primary|5-year Disease-Free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death.|5-year estimate reported after a median follow-up of 60 months|Intention-to-treat||percentage of participants|||Number
175737|NCT00073008|Primary|Tumor Response in the Targeted Population Through the End of Treatment|Disease progression and tumor response (number of participants achieving a complete response [CR] or partial response [PR]), using standardized criteria (Response evaluation criteria in solid tumors). CR, disappearance of all target lesions; PR, 30% decrease in the sum of the longest diameter of target lesions; progressive disease, 20% increase in the sum of the longest diameter of target lesions; stable disease, small changes that do not meet above criteria. Disease assessment was done at baseline and then every 8 weeks after starting treatment, until the participant discontinued treatment.|Baseline and then every 8 weeks through end of treatment|Targeted Population: all randomized participants who received at least one dose of study drug and had either the histological subtypes of adenocarcinoma with bronchioloalveolar carcinoma features or pure bronchioloalveolar carcinoma, or were never smokers with any histology of non-small cell lung cancer (NSCLC)||participants|||Number
175738|NCT00072761|Primary|Recurrence of an Infarct, Defined as a Stroke or a New or Enlarged Silent Cerebral Infarct|The primary end point was the recurrence of infarct or hemorrhage as determined by neuroimaging, clinical evidence of permanent neurologic injury, or both. A new infarct had to meet the criteria for a silent cerebral infarction; an enlarged silent cerebral infarct was defined as a previously identified silent cerebral infarct that increased by at least 3 mm along any linear dimension in any plane on MRI.|From study entry to study exit|Randomization assignments were provided by the statistical data coordinating center with the use of a permuted block design, with stratification according to site, age, and sex. Participants were assigned in a 1:1 ratio to the observation or transfusion group and were followed until study exit or study endpoint.||infarct recurrence per 100 person years|||Number
175739|NCT00072566|Secondary|Median Overall Survival|Calculated using the method of Kaplan-Meier.|Time from first day of treatment to time of death due to any cause, assessed up to 3 years|||months||95% Confidence Interval|Median
175740|NCT00072566|Secondary|Response Rate Based on the RECIST|Percentage of patients with a confirmed partial or complete response using RECIST v1.0 criteria. Complete response was defined as the disapperance of all target and nontarget lesions, no evidence of new lesions and normalization of CA-125; Partial response was defined as a 30% or greater reduction in the sum of the longest dimensions of all target lesions and no unequivocal progression of nontarget lesions, lasting at least 4 weeks.|Up to 3 years|||percentage of responding patients|||Number
175741|NCT00072566|Primary|Median Time to Progression|Time from treatment initiation to disease progresion calculated using the method of Kaplan-Meier. RECIST v1.0 was used to evaluate response. Progression was defined as a 20% or greater increase in the sums of the longest dimensions of target lesions, or the appearance of new lesions within 8 weeks of study entry.|Up to 3 years|||months||95% Confidence Interval|Median
175742|NCT00072475|Primary|Time to Transformation to AML|Time to transformation to AML is defined as the time from registration to the transformation of MDS to AML or death of any cause. Participants not meeting these criteria were censored at the date of last follow-up. This outcome was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
175743|NCT00072475|Secondary|Progression-free Survival|"Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last clinical assessment. The median PFS with 95% CI was estimated using the Kaplan Meier method.~Progression is defined as~For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts~For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts~For patients with 10-19% bone marrow blasts: increase to ≥20% blasts~One or more of the following: 50% or greater decrement from maximum remission/response levels in ANC < 1.5 K/L or PLT< 100 K/L, or reduction in HGB by at least 2 g/dL or becoming transfusion dependent~Progression after HI: Includes one or more of the following~Decrement of 50% or greater from maximum response levels in ANC < 1.5 K/L or PLT < 100 K/L~Reduction in HGB concentration by at least 2 g/dL~Becoming transfusion dependent"|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
175744|NCT00072475|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 5 years)|||months||95% Confidence Interval|Median
175745|NCT00072475|Secondary|Duration of Response|"Duration of response (DOR) was defined as the time from response (complete remission, partial remission or hematologic improvement) to progression or death of any cause. Responding and alive patients were censored at the date of last follow-up. The median DOR with 95% CI was estimated using the Kaplan Meier method.~Response was measured by International Standardized Response Criteria for MDS (described in above outcome measure)."|5 yrs|Per the description, only patients who achieved a response were evaluable for this outcome.||months||95% Confidence Interval|Median
175746|NCT00072475|Primary|Number of Participants With Response|"Response was measured by International Standardized Response Criteria for MDS~Complete Response: Bone marrow showing < 5% myeloblasts with normal maturation of all cell lines; Hgb > 11 g/dL (untransfused), ANC ≥1.5 K/L, PLT ≥ 100 K/L, No blasts, no dysplasia~Partial remission: All of the CR criteria (if abnormal at baseline), except BM evaluation. Blasts decreased by ≥ 50% over baseline. Cellularity and morphology are not relevant.~Hematologic improvement:~Erythroid (HI-E): For participants with baseline HGB < 11g/dL, Major: > 2g/dL increase, transfusion independence. Minor: 1-2g/dL increase, ≥ 50% decrease in transfusion requirements~Platelet (HI-P): For participants with baseline PLT < 100 K/L: Major: absolute increase of > 30 K/L, transfusion independence. Minor: ≥ 50% increase (net increase of >10 K/L)~Neutrophil (HI-N): For participants with baseline ANC < 1.5 K/L, Major: > 100% increase (net increase > 0.5 K/L). Minor: > 100% increase (absolute increase < 0.5 K/L)"|Duration of study (up to 5 years)|||participants|||Number
175747|NCT00072449|Secondary|Toxicity|patients only received drug for 8 weeks|8 weeks - 2 cycles|||related episodes|||Number
175748|NCT00072449|Secondary|Overall Survival|survival was evaluated q 2months|47 months|||months||95% Confidence Interval|Median
175749|NCT00072449|Secondary|Progression-free Survival|pt had MRI every 3 months|pt had MRI q3months|||days||95% Confidence Interval|Median
175750|NCT00072449|Primary|Radiographic Response|it at any time point patient progresses no more scans are required, patient is off study|1 month, 2 months and then q3months|||participants|||Number
175751|NCT00072293|Secondary|Site of Recurrence|Site of recurrence of breast cancer|Reported after a median follow-up of 60 months|Intention-to-treat||participants|||Number
175754|NCT00072280|Primary|"Failure-free Survival (FFS) in Chemotherapy Plus Possible Surgery Arm"|Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section).|Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years)|By protocol design, only eligible patients were considered in the evaluation for the primary outcome measure. One (1) patient was found ineligible, leaving two (2) for the analysis population.||participants|||Number
175755|NCT00072189|Secondary|Progression-free Survival|"Estimated using the product-limit method of Kaplan and Meier.~Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions."|From the date of study registration to the first documentation of progressive tumor, assessed up to 7 years|||months||95% Confidence Interval|Median
175756|NCT00072189|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Up to 7 years|||months||95% Confidence Interval|Median
175757|NCT00072189|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 7 years|||percentage of responding participants|||Number
175758|NCT00072176|Primary|Progression-free Survival (Tumor Progression)|Time to tumor progression or death|5 years|All patients who were evaluable for response||months||95% Confidence Interval|Median
175759|NCT00072176|Primary|Objective Clinical Response Rate|Defined as proportion of patients with 30% decrease in the sum of the longest diameters of the target lesions (partial response) maintained for at least 4 weeks, or complete disappearance of disease and cancer related symptoms (complete response) and confirmed on independent radiology review.|Up to 5 years|Patients who were evaluable for response.||percentage of patients with response||95% Confidence Interval|Number
175760|NCT00071981|Secondary|Median Overall Survival (OS)|OS was defined as the time from registration to death from any cause.|assessed every 3 month within 2 years and every 6 months betwen 2 and 5 years|148 eligible and treated patients were included in the analysis||months||95% Confidence Interval|Median
175761|NCT00071981|Secondary|Objective Response Rate|Tumor response was assessed via Response Evaluation Criteria in Solid Tumors (RECIST) v1.0. Objective response rate is calculated as the number of patients with complete response (disappearance of all lesions) or partial response () divided by total number of evaluable patients.|Tumor response was assessed in weeks 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 6 months after last vaccination|148 eligible and treated patients were included in the analysis||percentage of participants||95% Confidence Interval|Number
175762|NCT00071981|Secondary|Helper T Cell Response to Tetanus|Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.|Immune response was assessed at pre-registration, in weeks 1,3,5,7,8|128 eligible and treated patients who had data about HTL response to tetanus peptide were included in the analysis||percentage of participants||95% Confidence Interval|Number
175763|NCT00071981|Secondary|Helper T-cells Response to 6MHP|Helper T cell response was evaluated by tritiated thymidine proliferation assay with fresh/cryopreserved PBL in the presence of each of the helper peptides.|Immune response was assessed at pre-registration, in weeks 1,3,5,7,8|128 eligible and treated patients who had data about helper T cell response were included in the analysis||percentage of participants||95% Confidence Interval|Number
175764|NCT00071981|Primary|Cytotoxic T-cell Lymphocytes (CTL) Response Rate|Assessment of CTL response was based on a fold-increase in T cell response measure by interferon-gamma ELIspot assay.|Immune response was assessed at pre-registrtion, in weeks 1, 3, 5, 7, 8|140 eligible and treated patients who had CTL response data were included in the analysis||percentage of participants||95% Confidence Interval|Number
175765|NCT00071890|Secondary|AIDS Events|AIDS defined events according to CDC classification|Overall study|"IL-2 arm : Oesophageal candidasis at W196~Control arm :Ocular B-cell lymphoma at W43,Oesophageal candidasis at W82, B-cell lymphoma at W104"||event|||Number
175766|NCT00071890|Secondary|Changes in CD4 Counts at Week 72||week 72|||cells per mm3||Inter-Quartile Range|Median
175767|NCT00071890|Primary|Proportion of Patients Without Failure of Strategy From Week 0 to Week 72|"A failure of strategy is defined on the first occurrence of one of the following events:~CD4 T-lymphocyte count becomes < 350 cells/mm3 between Wk0 and Wk72 (count confirmed by a 2nd measurement after 2-4 weeks~Planned interruption of therapy at Wk24 cannot be done for any reason;~Anti-retroviral treatment is restarted between Wk24 and Wk72 for any reason~Subject experiences clinical progression of HIV infection to a stage C AIDS diagnosis (appendix I)~Subject expires between Wk0 and Wk72 (whatever the cause of death)~Subject is lost to follow up"|week 72|Intent to treat analysis, missing = failure.||Pourcentage||95% Confidence Interval|Number
175768|NCT00071812|Other Pre-specified|Adverse Events (AE) Overview|Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 48/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBRA99/NCT00583557).|Up to 56 weeks|||percentage of participants|||Number
175769|NCT00071812|Secondary|Mean Change in Modified Total Sharp Score at Week 24|The modified total Sharp score method was used to evaluate radiographs of hands/wrists for erosions (ERO) and joint space narrowing (JSN). The total modified Sharp score ranges from 0 (no radiographic damage) to 200 (worst possible radiographic damage) and is the sum of the normalized ERO score (range 0-100) and the normalized JSN score (range 0-100). Higher scores indicated more damage.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent and who had both a modified total Sharp score at baseline and at Week 24.||scores on a scale||Standard Error|Mean
175770|NCT00071812|Secondary|Time to First DAS28 Response|DAS28 response is defined as the time from the first dose to the first time at which a patient exhibited a “good” or a “moderate” improvement in RA disease activity, based on DAS28 improvements compared to baseline. Good response was defined as >1.2 change from baseline and DAS28 score ≤ 3.2. No response was defined as ≤ 0.6 change from baseline in DAS28 score or change between ≤ 1.2 and > 0.6 with a DAS28 score of > 5.1.|0 to 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||days||Full Range|Median
175771|NCT00071812|Secondary|Mean Change in Disease Activity Score 28 (DAS28) at Week 24|DAS is a composite index of a patient's level of RA disease activity. DAS28 is an abbreviated version of DAS, using a subset of 28 joints in the assessment, calculated based on 4 variables: 1) number of tender joints out of a total of 28 joints, 2) number of swollen joints out of a total of 28 joints, 3) ESR, 4) patient's global assessment of disease activity based on a 100-mm visual analog scale. The calculation provides a number on a scale from 0 to 10 (>5.1=active disease; <3.2=well controlled disease; <2.6=remission). Change from baseline >1.2 = good response and ≤0.6 = non-response.|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent and who had both a baseline and a Week 24 DAS28 score.||scores on a scale||Standard Error|Mean
175772|NCT00071812|Secondary|Time to First ACR70 Response, Based on ESR|Measure not posted because time to ACR70 response was unable to be determined due to the small number of patients achieving an ACR70 response in the study.|0 to 24 weeks||||||
175773|NCT00071812|Secondary|Time to First ACR50 Response, Based on ESR|Measure not posted because time to ACR50 response was unable to be determined due to the small number of patients achieving an ACR50 response in the study.|0 to 24 weeks||||||
175774|NCT00071812|Secondary|Time to First ACR20 Response, Based on ESR|The time to first ACR20 response (based on ESR) is defined as the time from the first dose to the first visit at which a patient first exhibited an ACR20 response, which may or may not have been sustained through Week 24.|0 to 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||days||Inter-Quartile Range|Median
175775|NCT00071812|Secondary|Percentage of Patients With an ACR70 Response at Week 24, Based on ESR|An ACR70 response is defined as having at least a 70% improvement in tender and swollen joints as well as a 70% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||percentage of participants|||Number
175776|NCT00071812|Secondary|Percentage of Patients With an ACR50 Response at Week 24, Based on ESR|An ACR50 response is defined as having at least a 50% improvement in tender and swollen joints as well as a 50% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||percentage of participants|||Number
175777|NCT00071812|Primary|Percentage of Patients With ACR20 (American College of Rheumatology) Response at Week 24, Based on Erythrocyte Sedimentation Rate (ESR)|An ACR20 response is defined as having at least a 20% improvement in tender and swollen joints as well as a 20% improvement in 3 of 5 other criteria (patient assessment, physician assessment, pain scale, disability/functional questionnaire, and acute phase reactant value based on erythrocyte sedimentation rate [ESR]).|Baseline, 24 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.||percentage of participants|||Number
175778|NCT00071799|Primary|Number of Participants Who Died|Count of participants who died during the study|42 months|Intent to treat population||participants|||Number
175779|NCT00071799|Post-Hoc|Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML) Based on the Last Bone Marrow Assessment|A sensitivity analysis of time to transformation to AML during the entire study was performed based on the last bone marrow assessment. Patients were censored based on the last bone marrow assessment.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.||months||95% Confidence Interval|Median
175780|NCT00071799|Secondary|Number of Participants in Different Categories of Adverse Experiences During Core Study Period|Patient counts for a variety of subsets of adverse experiences for the core study period (day 1 to 42 months). The individual options for Conventional Care Regimens (Best Supportive Care Only, Low-Dose Cytarabine, and Standard Chemotherapy) are presented as separate treatments.|Day 1 (randomization) to 42 months|Safety population excludes 4 Azacitidine patients, 3 Best Supportive Care Only patients, 5 Low-dose Cytarabine patients, and 6 Standard Chemotherapy patients who were randomized/assigned to those regimens but did not receive treatment.||participants|||Number
175781|NCT00071799|Secondary|Number of Infections Per Treatment Year Requiring Intravenous Antibiotics, Antifungals or Antivirals|The on-treatment adverse event rate of infection requiring IV antibiotics, antifungals, or antivirals per patient-years. The on-treatment period was considered the period from the date of randomization to the last treatment study visit.|Day 1 (randomization) to 42 months|Intent to treat population||infections per treatment year|||Number
175782|NCT00071799|Secondary|Duration of Any Hematologic Improvement|The duration of improvement was defined as the time from the date of hematologic improvement until the date of first documented progression or relapse after hematologic improvement or death from any cause.|Day 1 (randomization) to 42 months|Intent to treat population. Participants showing hematologic improvement were 48 in azacitidine and 31 in conventional care.||months||95% Confidence Interval|Median
175783|NCT00071799|Secondary|Time to Disease Progression, Relapse After Complete or Partial Remission, or Death From Any Cause|The time to disease progression, relapse after complete or partial remission (CR, PR), or death from any cause was defined as the time from the date of randomization until the first date of documented disease progression, relapse after CR or PR, or death from any cause.|Day 1 (randomization) to 42 months|Intent to treat population. The number of participants with disease progression, relapse after remission or death from any cause is 84 for azacitidine and 79 for conventional care. Remaining participants were censored.||months||95% Confidence Interval|Median
175784|NCT00071799|Secondary|Number of Participants Showing Hematologic Improvement Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS) Assessed by Independent Review Committee|"IWG 2000 Criteria: Pretreatment=hemoglobin <100g/L or RBC transfusion-dependent, platelet count <100x10^9/L or platelet transfusion dependent, absolute neutrophil count <1.5x10^9/L.~Erythroid response: Major->20g/L increase or transfusion independent. Minor- 10-20g/L increase or >=50% decrease in transfusion requirements.~Platelet response: Major-absolute increase of >=30x10^9/L or platelet transfusion independence. Minor->=50% increase.~Neutrophil response: Major->=100% increase or an absolute increase of >0.5x10^9/L. Minor->=100% increase and absolute increase of <0.5x10^9/L."|Day 1 to 42 months|Intent to treat population.||participants|||Number
175785|NCT00071799|Secondary|Number of Participants Considered Hematologic Responders by Investigator Determinations Using International Working Group (IWG 2000) Criteria for Myelodysplastic Syndrome (MDS)|"Investigator determined responses followed IWG criteria for~complete remission(CR): repeat bone marrow show <5% myeloblasts, and peripheral blood evaluations lasting >=2 months of hemoglobin(>110 g/L), neutrophils(>=1.5x10^9/L), platelets(>=100x10^9/L), blasts (0%) and no dysplasia~partial remission(PR) is the same as CR for peripheral blood: bone marrow shows blasts decrease by >=50% or a less advanced FAB classification from pretreatment~stable disease(SD) is a failure to achieve at least a partial remission, but with no evidence of progression for at least 2 months."|Day 1 to 42 months|Intent to treat population.||participants|||Number
175786|NCT00071799|Secondary|Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Independent at Baseline|Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population||participants|||Number
175787|NCT00071799|Secondary|Summary of Participants' Platelet Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|Summary of dependence and independence from platelet transfusion at baseline and during treatment for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population||participants|||Number
175788|NCT00071799|Secondary|Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Independent at Baseline|Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were independent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population||participants|||Number
175789|NCT00071799|Secondary|Summary of Participants' Red Blood Cell (RBC) Transfusion Status for Participants Who Were Transfusion Dependent at Baseline|Summary of dependence and independence from red blood cell (RBC) transfusion at baseline and during treatment, for patients who were dependent at baseline. A patient was considered transfusion independent at baseline if the patient had no transfusions during the 56 days prior to randomization. During study, a patient was considered transfusion independent during the on-treatment period if the patient had no transfusions during any 56 consecutive days or more. Otherwise, the patient was considered transfusion dependent.|Day 1 (randomization) to 42 months|Intent to treat population||participants|||Number
175790|NCT00071799|Secondary|Kaplan-Meier Estimates for Median Time to Transformation to Acute Myeloid Leukemia (AML)|The time to transformation to AML was defined as the number of days from the date of randomization until the date of documented AML transformation, defined as a bone marrow blast count ≥ 30% independent of baseline bone marrow count. Patients who did not transform to AML were censored at the date of last follow-up or date of death.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who were transformed to AML are 78 for azacitidine and 71 for conventional care. Remaining participants were censored based on the last bone marrow assessment.||months||95% Confidence Interval|Median
175791|NCT00071799|Secondary|Kaplan-Meier Estimate for Median Time to Transformation to Acute Myeloid Leukemia (AML) or Death From Any Cause, Whichever Occurred First|The time to transformation to AML or death from any cause (whichever occurred first) was defined as the number of days from the date of randomization until the date of documented AML transformation or death from any cause. Patients who did not transform to AML or die were censored at the date of last follow-up.|Day 1 (randomization) to 42 months|Intent to treat population. Participants who either transformed to AML or died are 120 for azacitidine and 132 for conventional care. Remaining participants were censored.||months||95% Confidence Interval|Median
175792|NCT00071799|Primary|Summary of Subgroup Analyses for Kaplan-Meier Estimates for Time to Death From Any Cause|"Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.~Subgroups that were analyzed are age, gender, French-American-British (FAB) classification, World Health Organization (WHO) classification and International Prognostic Scoring System (IPSS) classification."|Day 1 (randomization) to 42 months|Intent to treat population. Includes participants who died and those who were censored.||months|||Number
175793|NCT00071799|Primary|Kaplan-Meier Estimates for Median Time to Death From Any Cause|Kaplan-Meier estimates for the median months until death from any cause within the intent-to-treat population. Patients surviving at the end of the follow-up period were censored at the date of last contact. If a patient withdrew consent to follow-up or was lost to follow-up, the patient was censored as of the last date of contact.|Day 1 (randomization) to 42 months|Intent to treat population. Includes participants who died and participants who were censored.||months|||Number
175794|NCT00071760|Secondary|Plasma FPV CL/F Expressed in mL/Min|The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.|Week 48|PK Population|||||
175798|NCT00071760|Secondary|Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events|No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.|Week 48|PK Population|||||
175799|NCT00071760|Secondary|Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child’s Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10|Parent/guardian perceptions of FPV/RTV BID was assessed using a Parent/Guardian Perception of Study Medication questionnaire. Questions 1 to 4 ask directly about the parent/guardian's assessment of the color, texture/consistency, odor, and general satisfaction. Questions 5 to 10 ask about the parent/guardian’s perception of the child’s assessment of the oral suspension (Items: 5=reaction to new medicine [med.]; 6=taste; 7=acceptance; 8=swallowing; 9=willingness compared to other med.; 10=overall liking. Data for items 6/10 are reported in response categories: 1-3=dislike; 4=neutral; 5-7=like.|Weeks (W) 2, 24, and 48/premature study discontinuation|Safety Population||participants|||Number
175800|NCT00071760|Secondary|Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4|P/G perceptions of FPV/RTV BID were assessed using a P/G Perception of Study Medication questionnaire administered during Weeks 2, 24, and 48/premature study discontinuation. Questions 1 to 4 ask directly about the P/G's assessment of 1=color, 2=texture/consistency, 3=odor, and 4=general satisfaction. Questions 5 to 10 ask about the P/G’s perception of the child’s assessment of the oral suspension. Data are reported as the number of participants with the indicated response by question, response category (1-3=dislike, 4=neutral, 5-7=like), and timing of visit.|Weeks 2, 24, and 48/premature study discontinuation|Safety Population||participants|||Number
175801|NCT00071760|Secondary|Number of Participants Reporting Perfect Adherence Over the 3 Days and Last Weekend Prior to the Study Visits at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire|A separate questionnaire were administered for FPV and RTV. Items 1-4 of the Adherence Questionnaire measured a participant's adherence with FPV or RTV during the last 3 days and the weekend prior to the indicated study visits. Question 5 queried about the number of doses of FPV or RTV missed since the participant’s last study visit. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit.|Weeks 2, 12, 24, and 48|Safety Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
175802|NCT00071760|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)|A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.|Baseline through Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable||participants|||Number
175803|NCT00071760|Secondary|Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease|A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.|Baseline through Week 48|VF: par. with failure to achieve plasma HIV-RNA <400 copies/mL by Week 24; or confirmed HIV-RNA rebound to >=400 copies/mL any time after achieving plasma HIV-RNA <400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.||participants|||Number
175804|NCT00071760|Secondary|Plasma RTV CL/F Expressed in mL/Min|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ).|Week 48|PK Population. Only those participants contributing data were analyzed.||mL/min||95% Confidence Interval|Geometric Mean
175805|NCT00071760|Secondary|Plasma RTV CL/F Expressed in mL/Min/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.||mL/min/kg||95% Confidence Interval|Geometric Mean
175806|NCT00071760|Secondary|Plasma RTV Cτ|The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||µg/mL||95% Confidence Interval|Geometric Mean
175807|NCT00071760|Secondary|Plasma RTV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||µg/mL||95% Confidence Interval|Geometric Mean
175808|NCT00071760|Secondary|Plasma Ritonavir (RTV) AUC (0-τ)|Plasma samples were assayed for RTV concentrations using a validated assay. The GSK Department of Clinical Pharmacology Modeling and Simulation conducted PK analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.|Week 48|PK Population. Only those participants contributing data were analyzed.||hr*µg/mL||95% Confidence Interval|Geometric Mean
175832|NCT00071721|Secondary|Functional Performance Assessed by the Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory|Alzheimer's Disease Cooperative Study Activities of Daily Living Score (ADCS-ADL) is a structured questionnaire about activities of daily living, administered to the subject's caregiver/study partner. The range of this instrument is 0 to 78 with lower numbers indicating greater impairment.|24 months|||Units on a scale||Standard Deviation|Mean
175809|NCT00071760|Secondary|Number of Participants With the Indicated Virological Outcome at Week 48|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Virologic success was defined as plasma HIV-1 RNA <400 copies/mL. Virologic failure: (1) HIV-1 RNA >=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 >=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons (withdrew consent, loss to follow-up, moved, etc.).|Week 48|ITT-E Population. Only those participants contributing data were analyzed.||participants|||Number
175810|NCT00071760|Secondary|Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at indicated time points minus the value at Baseline.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. Not all participants had values at both baseline and the indicated time points; thus, change from baseline could not be calculated for all participants.||Percentage of cells||Inter-Quartile Range|Median
175811|NCT00071760|Secondary|Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48|Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. A CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.||Percentage of cells||Inter-Quartile Range|Median
175812|NCT00071760|Secondary|Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. In the MSD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
175813|NCT00071760|Secondary|Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. Change from Baseline in plasma HIV-1 RNA was calculated as the value at the indicated time point minus the value at Baseline.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.||log10 copies/mL||Inter-Quartile Range|Median
175814|NCT00071760|Secondary|Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)|Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies.|Baseline and Weeks 4, 12, 24, 36, and 48|ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.||log10 copies/mL||Inter-Quartile Range|Median
175815|NCT00071760|Secondary|Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)|Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation=Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.|Baseline and Weeks 4, 12, 24, 36, and 48|Intent-to-Treat Exposed (ITT-E) Population: participants who received chronic therapy with FPV or FPV/RTV at any dose. Only those participants contributing data at the indicated time points were analyzed.||participants|||Number
175816|NCT00071760|Primary|Number of Participants Who Permanently Discontinued the Treatment Due to an AE|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.|Baseline (Day 1) until Week 48|Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.||participants|||Number
175817|NCT00071760|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)|An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE is considered TE if it has an onset date on or after the date of the first dose of study drug, and on or before the date of the final dose of study drug. As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.|Baseline (Day 1) until Week 48|Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.||participants|||Number
175818|NCT00071760|Primary|Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities|TE toxicities were presented for each laboratory parameter. A toxicity was considered TE if it was greater than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Neutropenia is a decrease (d) in the number of Ns, d/increase (I) in glucose is hypo (Hp)/hyper (Hy)glycemia, in potassium is Hp/Hykalemia, and in sodium is Hp/Hynatremia. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.|Baseline (Day 1) until Week 48|Safety Population. Only those participants contributing data were analyzed.||participants|||Number
176183|NCT00064350|Secondary|Overall Survival|Overall survival is defined as the duration from randomization to death or last known alive. Only randomized patients were included in this analysis.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years|||Months||95% Confidence Interval|Median
175819|NCT00071760|Primary|Median Change From Baseline in Serum Lipase at Weeks 4, 12, 24, and 48|Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, and 48|Safety Population. Only those participants contributing data were analyzed.||Units per liter (U/L)||Inter-Quartile Range|Median
175820|NCT00071760|Primary|Median Change From Baseline in Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) Cholesterol, Triglyceride (TG), Potassium, and Sodium at Weeks 4, 12, 24, 36, and 48|Blood samples of all participants were generally collected under non-fasting conditions (given the age of participants) for the evaluation of cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in cholesterol, serum glucose, HDL cholesterol, LDL cholesterol, triglyceride, potassium, and sodium was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48|Safety Population. Only those participants contributing data were analyzed.||Millimoles per liter (mmol/L)||Inter-Quartile Range|Median
175821|NCT00071760|Primary|Median Change From Baseline in Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Weeks 4, 12, 24, 36, and 48|Blood samples of the participants were collected for the evaluation of ALT and AST. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in ALT and AST was calculated as the value at the indicated time point minus the value at Baseline.|Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48|Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment. Only those participants contributing data were analyzed.||International units per liter (IU/L)||Inter-Quartile Range|Median
175822|NCT00071760|Primary|Plasma Unbound APV Percent Protein Binding (%Cτ)|Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. APV %Cτ unbound is the percentage of the total APV Cτ that is unbound.|Week 48|PK Population. Only those participants contributing data were analyzed.||Percentage of total APV Cτ unbound||Standard Deviation|Mean
175823|NCT00071760|Primary|Plasma Unbound APV Cτ|"Participants who are <2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. Unbound or free APV is the fraction of drug that is not bound to protein. Cτ is the plasma concentration at the end of the dosing interval at steady state."|Week 48|PK Population. Only those participants contributing data were analyzed.||µg/mL||Standard Deviation|Mean
175824|NCT00071760|Primary|Plasma APV CL/F Following Dosing Expressed in mL/Min|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).|Week 48|PK Population. Only those participants contributing data were analyzed.||mL/min||95% Confidence Interval|Geometric Mean
175825|NCT00071760|Primary|Plasma APV CL/F Following Dosing Expressed in mL/Min/kg|Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.|Week 48|PK Population. Only those participants contributing data were analyzed.||Milliliters/minute/kilogram (mL/min/kg)||95% Confidence Interval|Geometric Mean
175826|NCT00071760|Primary|Plasma APV Cτ|The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Geometric Mean
175827|NCT00071760|Primary|Plasma APV Cmax|The maximum concentration at steady state (Cmax) was measured.|Week 48|PK Population. Only those participants contributing data were analyzed.||Micrograms per milliliter (µg/mL)||95% Confidence Interval|Least Squares Mean
175828|NCT00071760|Primary|Plasma Amprenavir (APV) AUC (0-tau[τ])|"Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC[0-τ]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hours, hr."|Week 48|Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.||Hr per microgram/milliliter (hr*µg/mL)||95% Confidence Interval|Geometric Mean
175829|NCT00071721|Secondary|Participant’s Clinical Condition or Endpoint Assessed With the ADCS-Clinical Global Impression of Change (ADCS-CGIC)|ADCS-Clinical Global Impression of Change (ADCS-CGIC) provides a means to reliably assess global change from baseline. It provides a semi-structured format to allow clinicians to gather necessary clinical information from both the participant and informant, in order to make an overall impression of clinical change. The range of this instrument is 1 to 7 with lower numbers indicating improvement and higher numbers indicating a worsened state.|24 months|||Units on a scale||Standard Deviation|Mean
175830|NCT00071721|Secondary|Agitation Measured by the Cohen-Mansfield Agitation Inventory (CMAI), Community Version|The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item caregiver rating questionnaire for the assessment of agitation in older persons. It includes descriptions of 29 agitated behaviors, each rated on a 7-point scale of frequency. The range of this instrument is 29 to 203 with higher numbers indicating greater impairment.|24 months|||Units on a scale||Standard Deviation|Mean
175831|NCT00071721|Secondary|Global Severity of Dementia Using the CDR Sum of Boxes|Clinical Dementia Rating, Sum of Boxes (CDR-SOB) is a global rating of dementia severity based on the clinician's interpretation of the history and examination. The range of this instrument is 0 to 18 with higher numbers indicating greater impairment.|24 months|||Units on a scale||Standard Deviation|Mean
175833|NCT00071721|Secondary|Cognitive Performance Assessed by the Alzheimer's Disease Assessment Scale-cognitive Subtest (ADAS-cog)|Alzheimer's Disease Assessment Scale, cognitive sub-scale in points per year (ADAS-cog) is a psychometric measure sensitive to change in mild to moderate AD. The range of this instrument is 0 to 70 with higher numbers indicating greater impairment.|24 months|||Units on a scale||Standard Deviation|Mean
175834|NCT00071721|Primary|Presence of Agitation and/or Psychosis Measured by the Neuropsychiatric Inventory (NPI) Combined With an Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician|NPI quantifies behavioral changes in dementia, including depression, anxiety, psychosis, agitation, and others. This is a questionnaire administered to the subject's study partner. The range of this instrument is 0 to 120 with higher numbers indicating greater impairment. To determine whether or not psychosis or agitation is present, there is no cutoff score but is based on the clinician’s judgment. In the NPI, the subject responds to ‘Yes’ or ‘No’ questions. Then it is determined how often psychosis or agitation occurs and if it is mild, moderate or severe.|24 months|||Participants|||Number
175835|NCT00071513|Secondary|School Attachment|"School attachment measure consisted of 4 items. Item responses range from 0 (unsatisfied, rarely attended, not involved, etc.) to 6 (highly satisfied, regularly attended, very involved, etc). Scores could range from 0 to 36 with higher scores indicating more positive school attachment. Item were:~My overall satisfaction with classes was… Overall, how safe did school feel last semester… Overall, how friendly did school feel… How involved were you in school activities…"|18 months|T-test differences for HSTS versus Brief Intervention on the School Attachment scale.||units of a scale||Standard Deviation|Mean
175836|NCT00071513|Primary|Change in Short Moods and Feelings Questionnaire (SMFQ)|"The Short Moods and Feelings Questionnaire is a 13 item measure of level of self reported depressive symptoms. Each item in scored on a 3-point Likert scale as follows: True (0), Sometimes (1), and Not True (2) rated within the timeframe of the previous two weeks. A total score is obtained; scores can range from 0 to 26. Total scores of 12 or higher may signify that a child/adolescent is suffering from depression. Higher scores on this scale suggest a worse outcome or greater endorsement of depressive symptoms. Change is measured based on two time points baseline to the 18 months follow-up assessment."|Baseline to 18 months|The main study hypothesis was that at-risk middle school students randomly assigned to participate in the CAST-T/HSTS versus the Brief Intervention would demonstrate a greater reduction in self-reported depressive symptoms after the 8th grade intervention as well as lower rate of increase in depressive symptoms at the 18 mos. follow-up.||units on a scale||Standard Deviation|Mean
175837|NCT00071487|Other Pre-specified|Adverse Events (AE) Overview|Includes AEs reported in patients from the first dose of study agent throughout the study up to the Week 76/exit visit or 8 weeks following the last dose of study agent for patients who withdrew from this study or decided not to participate in the optional continuation protocol (LBSL99/NCT00583362).|Up to 84 weeks|||percentage of participants|||Number
175838|NCT00071487|Secondary|Percentage of Patients With a Reduction in Prednisone Dose|Percentage of patients whose average prednisone dose has been reduced by ≥ 50% and/or has been reduced to ≤ 7.5 mg/day during Weeks 40 through 52 in patients receiving greater than 7.5 mg/day at baseline.|Baseline, weeks 40 to 52|Analysis was performed on a subgroup of the MITT population, which included only patients with baseline prednisone dose > 7.5 mg/day.||percentatge of particpants|||Number
175839|NCT00071487|Secondary|Time to First Type A/B SLE Flare (as Defined Using BILAG) Over 52 Weeks|SLE flare indicates an increase in SLE disease activity. An SLE flare was a type A or B SLE flare (as defined using BILAG) compared with the previous visit.|0 to 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||days||Inter-Quartile Range|Median
175840|NCT00071487|Secondary|Area Under the Curve (AUC) of BILAG Score at Week 52|The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.The normalized AUC was created as the ratio of the area under the global BILAG score curve divided by baseline score.|Baseline and every 4 to 8 weeks through Week 52|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||ratio score*days||Standard Error|Mean
175841|NCT00071487|Secondary|Percentage Change From Baseline in British Isles Lupus Activity Group (BILAG) Score at Week 52|The BILAG index is a clinical measure of lupus disease activity. BILAG uses a single score for each of the 8 organ domains; range is from severe to no disease (A to E). The global BILAG score is the sum of the numerical scores in the 8 domains assigning A=9, B=3, C=1, D=0, E=0.|Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||percent change||Standard Error|Mean
175842|NCT00071487|Secondary|Area Under the Curve (AUC) of SELENA SLEDAI Score at Week 52|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare. The normalized AUC was created as the ratio of the area under the SELENA SLEDAI score curve divided by baseline score.|Baseline and every 4 to 8 weeks through Week 52|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||ratio score*days||Standard Error|Mean
175843|NCT00071487|Secondary|Percentage Change From Baseline in SELENA SLEDAI Score at Week 52|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare|Baseline, 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||percent change||Standard Error|Mean
175844|NCT00071487|Primary|Time to First Mild/Moderate or Severe SLE Flare (SLE Flare Index)|"The SLE Flare Index categorized SLE flare as mild or moderate or severe based on 5 variables: 1) change in SELENA SLEDAI score from the most recent assessment to current, 2) change in signs or symptoms of disease activity, 3) change in prednisone dosage, 4) use of new medications for disease activity or hospitalization, and 5) change in Physician's Global Assessment score, a visual analog scale scored from 0 to 3 (1=mild, 2=moderate, 3=severe)."|0 to 52 weeks|Analysis was performed on a MITT population, defined as all patients who were randomized and received at least 1 dose of study agent.||days||Inter-Quartile Range|Median
175845|NCT00071487|Primary|Percentage Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index (SELENA SLEDAI) Score at Week 24.|SELENA SLEDAI is calculated from 24 individual descriptors; 0 indicates inactive disease and the maximum theoretical score is 105; scores > 20 are rare.|Baseline, 24 weeks|Analysis was performed on a modified intention-to-treat (MITT) population, defined as all patients who were randomized and received at least 1 dose of study agent.||percent change||Standard Error|Mean
176238|NCT00062764|Secondary|Average Increase in Weight After Treatment||48 weeks|||kg||Full Range|Mean
175846|NCT00071396|Primary|Overall Response|Overall response categorized as 'Complete Remission,' 'Partial Remission,' or 'No Response.' Blood tests weekly while on active therapy, within 4-6 weeks following last dose of therapy, and every 3 to 6 (+/- month) thereafter as long as on study. Repeat bone marrow biopsy/aspirate with flow cytometry as applicable at the end of first course of therapy, (1 week) within 4-6 weeks following the last dose of therapy and every 6 to 12 months (+/-) thereafter as long as on study.|After each 4 week course of treatment|Analysis treated population 41 evaluable patients (44 treated, 3 not evaluable for response).||Participants|||Number
175847|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Bodily Pain Index (MOSBPI) from baseline to post-intervention across treatment group. Minimum Score = 0 (more); Maximum Score = 100 (less). Positive Mean Change scores indicate improvement (an increase in scale score/less pain).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.||Units on a scale||Standard Deviation|Mean
175848|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) Mental Component Score (MOSMCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better) , Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.||Units on a scale||Standard Deviation|Mean
175849|NCT00071110|Secondary|Change in Functioning and Health-related Quality of Life as Rated by the Medical Outcomes Survey-Version 1 (MOS-36) Physical Component Score (MOSPCS)|Mean change in scores on the Medical Outcomes Survey-Version 1 (MOS-36) PHYSICAL Component Score (MOSPCS) from baseline to post-intervention across treatment group. Minimum Score = 0 (worse); Maximum Score = 100 (better), Normed to be at 50 on a control population. Positive Mean Change scores indicate improvement (an increase in scale score/better).|Mean Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.||Units on a scale||Standard Deviation|Mean
175850|NCT00071110|Primary|Antidepressant Response, Defined as a Hamilton Depression Rating Scale Score Relative Decrease of 50 % or More and a Final Score < 10|Number of participants whose Hamilton Depression Rating Scale score decreased at least 50% and had a final score less than 10. Minimum score = 0 (best). Maximum score = 52 (worst). The 17 item scale assesses depression symptoms, including Depressed Mood, Feelings of Guilt, Suicidal Ideation, Insomnia, Anxiety, Weight Change, and Insight.|Change from Baseline to Post-Intervention Endpoint|ITT, excluding the first four sham acupuncture subjects, whom the primary acupuncturist erred in treating. Although he correctly used the sham electricity procedure, for these subjects he placed needles in the verum electroacupuncture points of GV-20 and Yin tang.||participants|||Number
175851|NCT00071058|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|60 months, 19 days|||Participants|||Number
175852|NCT00071058|Primary|Percentage of Participants With a Partial or Complete Response|Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all signs and symptoms of tumor for a period of at least 4 weeks. Partial response is defined as at least a 30% decrease in the sum of the longest diameter of all measured lesions lasting for a period of 4 weeks.|Every 6 weeks for up to a year|||Percentage of participants|||Number
175853|NCT00071032|Secondary|Composite Outcomes (a) Death, Myocardial Infarction, and Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism and Stroke)||In-hospital||||||
175854|NCT00071032|Secondary|Myocardial Infarction||In-hospital||||||
175855|NCT00071032|Secondary|Length of Stay in Hospital||In-hospital||||||
175856|NCT00071032|Secondary|Function (e.g., Lower Extremity Activities of Daily Living, Instrumental Activities of Daily Living, Fatigue/Energy)||30 and 60 days||||||
175857|NCT00071032|Secondary|Disposition Status (i.e., Nursing Home Placement)||60 days||||||
175858|NCT00071032|Secondary|Survival||30-daym, 60- day and long term up to 5 years||||||
175859|NCT00071032|Secondary|Postoperative Complications (e.g., Pneumonia, Wound Infection, Thromboembolism, Stroke)||In hospital||||||
175860|NCT00071032|Secondary|Myocardial Infarction, Unstable Angina, or Death for Any Reason||In-hospital|||participants|||Number
175861|NCT00071032|Primary|Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death|ascertained via telephone follow-up|60 days after randomization|||participants|||Number
175862|NCT00071006|Secondary|Overall Survival (OS)|Time in days from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1). Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). For participants who were alive, overall survival was censored at the last contact.|Baseline to death due to any cause or at least every 3 months after discontinuation of study treatment|Analysis for this particular endpoint was not conducted due to lack of efficacy.||Days||95% Confidence Interval|Median
175863|NCT00071006|Secondary|Population Pharmacokinetics of Axitinib (AG-013736)|Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.|Day 1 (pre-dose) and every 4 weeks up to 35 weeks||||||
175890|NCT00069823|Secondary|Change in Asthma Symptom Utility Index (ASUI)|Mean change. Scores on the ASUI range from 0 to 1, with higher scores indicating less severe asthma.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
175864|NCT00071006|Secondary|Plasma Vascular Endothelial Growth Factor (VEGF) Concentration|VEGF promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Plasma VEGF concentration evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot.|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Data was not summarized for this particular endpoint due to lack of efficacy.||pg/mL||Standard Deviation|Mean
175865|NCT00071006|Secondary|Vascular Endothelial Growth Factor Receptor 1 (VEGFR-1) and VEFGR Receptor 2 (VEGFR-2) Phosphorylation|Vascular endothelial growth factor (VEGF) promotes cancer progression by inducing angiogenesis via VEGF receptors, signals directly through receptors VEGFR-1 and VEGFR-2. Change in biomarkers related to VEGFR signal transduction pathways after axitinib treatment was assessed. Mononuclear (MNC) cell VEGF receptor expression and phosphorylation was assessed by in situ western blot analysis. VEGFR-1 and VEGFR-2 evaluations were performed using samples from peripheral blood plasma, bone marrow aspirate, bone marrow (Core) biopsy and bone marrow clot.|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Data was not summarized for this particular endpoint due to lack of efficacy.||picograms (pg)/mL||Standard Deviation|Mean
175866|NCT00071006|Secondary|Bone Marrow Micro Vessel Density (MVD)|Bone marrow MVD in tumors is a measure of angiogenesis and a prognostic indicator that correlates with an increased risk of metastasis in various cancers and with overall and relapse free survival in participants with AML or MDS. Bone marrow biopsies and bone marrow clot samples were assessed for MVD (cluster of differentiation 31 [CD31] staining).|Day 1, Week 2 thereafter every 4 weeks up to 35 weeks|Data was not summarized for this particular endpoint due to lack of efficacy.||vessels/square millimeter (mm^2)||Standard Deviation|Mean
175867|NCT00071006|Secondary|Duration of Response (DR)|Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). DR was calculated for the subgroup of participants with a confirmed objective tumor response.|First documentation of objective response until objective disease progression or discontinuation from the study due to any cause assessed every 4 weeks up to 35 weeks|Analysis for this particular endpoint was not conducted due to lack of efficacy.||Days||95% Confidence Interval|Median
175868|NCT00071006|Secondary|Percentage of Participants With Hematologic Improvement (HI)|HI was described by the number of individual and positively affected cell lines (Erythroid response, Platelet response, Neutrophil response). Improvements must last at least 2 months.|Baseline, Week 2 thereafter every 4 weeks up to 35 weeks and follow up (at least 30 days after last dose)|Analysis for this particular endpoint was not conducted due to lack of efficacy.||Percentage of participants||95% Confidence Interval|Median
175869|NCT00071006|Primary|Percentage of Participants With Objective Response (OR)|Participants with OR based on a assessment of confirmed complete remission (CR) or partial remission (PR) according to Cheson criteria for Acute myeloid leukemia (AML) and Myelodysplastic syndrome (MDS). CR: those with > 20% cellularity of bone marrow biopsy, no presence of extramedullary leukemia for AML, <5 % myeloblast cells for bone marrow with peripheral blood value lasting at least 1 month and 2 months for AML and MDS respectively. PR : those with all criteria for CR except 5-25 % blasts in bone marrow and at least 50% decrease in blast over pretreatment for AML and MDS respectively.|Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 4 weeks up to 35 weeks|Study Population included all participants who received at least 1 dose of study medication and had a baseline assessment of disease.||Percentage of participants||95% Confidence Interval|Number
175870|NCT00070941|Primary|Change in Hamilton Depression Scale|very severe, >23/29; severe, 19–22/29; moderate, 14–18/29; mild, 8–13/29; and no depression, 0-7/29 (Hamilton M., J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.)|12 weeks|||units on a scale||Standard Deviation|Mean
175871|NCT00070499|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|Patients were assessed for adverse events monthly every 4 weeks for the first year, every 6 months for years 2 and 3, and annually for years 4 and 5.|Eligible patients who started therapy||Participants with a given type of AE|||Number
175872|NCT00070499|Secondary|Two Year Relapse-free Survival|Relapse-free survival is measured from the date of documented (possibly unconfirmed) hematologic complete remission until loss of hematologic complete remission or death from any cause. Observations are censored at the date of last contact for patients last known to be alive with report of loss of hematologic complete remission.|every 3 months for the first year, every six months for years 2 and 3, annually for years 4 and 5|Eligible, treated patients who achieved a hematologic complete remission||Percent of population|||Number
175873|NCT00070499|Secondary|2-year Overall Survival (OS)|Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.|Every three months for the first year, every six months in years 2 and 3, and annually for years 4 and 5|All eligible patients who were treated||Percent of population|||Number
175874|NCT00070499|Secondary|Hematologic Response|Hematologic response assesses whether patients' blood counts return to normal|1 month after starting treatment|Eligible, treated patients who were evaluable for hematologic response||participants|||Number
175875|NCT00070499|Primary|Molecular Response Rate at 12 Months|Median value of baseline bcr-abl/bcr ratio from pretreatment was used as the baseline value for assessing each patient's molecular response. Molecular response criteria were: 1) not failed treatment on or before 12-month evaluation; 2) met criteria for hemalotogic response; 3) bcr-abl/bcr ration at 12-months must be 10,000 times smaller than the pretreatment ratio.|pretreatment and after 12 months of treatment|Patients with follow-up specimens assayed by reverse transcription polymerase chain reaction (RT-PCR)||participants|||Number
175876|NCT00070291|Secondary|Overall Survival|Overall survival was defined as time from randomization to death from any cause.|Assessed every 3 months for 2 years, then every 6 months for 1 year.|all 4 enrolled patients||Months||95% Confidence Interval|Median
175891|NCT00069823|Secondary|Change in Juniper Asthma Control Score(JACQ)|Mean change. Scores on the JACQ range from 0 to 6, with lower scores indicating better asthma control and 0.5 as the minimal clinically important difference.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
175877|NCT00070291|Primary|Response Rate (Complete and Partial Response)|Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin’s Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of > 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.|Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up.|all 4 enrolled patients||Proportion of participants||95% Confidence Interval|Number
175878|NCT00070109|Secondary|Pharmacokinetics by a Miniaturized Liquid Chromatography/Tandem Mass Spectrometry Method|The plasma concentration-versus-time data of trabectedin will be analyzed using noncompartmental methods. The typical population values of basic pharmacokinetic parameters will be estimated together with the interindividual variability.|At baseline, at 1, 8, 23, 24, 26, 30, 96, and 168 hours after trabectedin infusion in course 1||||||
175879|NCT00070109|Primary|Number of Patients With Dose-Limiting Toxicity (DLT)|Any Grade 3 or Grade 4 non-hematologic toxicity attributable to the Investigational drug with the specific exclusion of: Grade 3 nausea and vomiting; Grade 3 transaminase (AST/ALT) elevation that return to less than or equal to Grade 1 or baseline prior to the time for the next treatment cycle; Grade 3 fever or infection; Alopecia; Grade 4 neutropenia of > 7 days duration or Grade 4 thrombocytopenia of > 7 days duration, which requires transfusion therapy on greater than 2 occasions in 7 days, or which causes a delay of more than 14 days beyond the planned interval between treatment cycles.|1 Cycle|Two pts in Group 1 and 1 pt in Group 2 were excluded because they were removed from therapy prior to the DLT evaluation period and no DLT had been observed. No patients in Groups 3, 4, or 5 were evaluated for DLT.||participants|||Number
175880|NCT00070109|Primary|Response (Complete Response [CR] and Partial Response [PR])|Any patient who is enrolled and receives at least one dose of trabectedin will be considered evaluable for response if the individual receives at least one dose of trabectedin and: (1) is removed from protocol therapy because of progressive disease where progressive disease is documented either by imaging studies or clinical progression; or (2) has at least one radiographic evaluation of disease status after the start of protocol therapy and is not electively removed from protocol therapy with stable disease or is not lost to follow-up with stable disease. Patients who achieve a complete response (CR) - disappearance of all target lesions or partial response (PR) - >=30% decrease in the sum of the longest diameter of target lesions according to the RECIST criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.|Twenty-six (26) cycles of chemotherapy or termination of protocol therapy, whichever occurs first.|No pts in Group 1 were evaluated for response. 1 pt in Group 3 is excluded because the pt was removed from protocol therapy after cycle 3 when a cardiac evaluation was missed. The pt was removed prior to disease assessment on protocol therapy. 1 pt enrolled in Group 4 was excluded because patient was removed from therapy prior to chemotherapy.||participants|||Number
175881|NCT00070018|Primary|Progression-free Survival|Measured from date of registration to date of first observation of progression or symptomatic deterioration. Progression is defined as one or more of the following must occur. Unequivocal progression of disease in the opinion of the treating physician (an explanation must be provided). Appearance of a new lesion/site. Death due to disease without documented progression or symptomatic deterioration. Symptomatic deterioration is defined as global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter|||percentage of participants||95% Confidence Interval|Number
175882|NCT00069953|Secondary|Frequency of Patients With Persistent or Recurrent Disease Eligible for Surgical Salvage Resection||Analysis occurs with the primary outcome measure.||||||
175883|NCT00069953|Secondary|Frequency of Major (Grade 4) Acute Treatment-related Toxicities||From start of chemotherapy to surgery or 2 months after chemoradiation (for patients not undergoing surgery).||||||
175884|NCT00069953|Primary|Overall Survival (1-year Rate Reported)|One-year survival estimate is reported. Survival time is defined as time from registration to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 1 year. On the basis of a 1-year survival rate of 60% from the Radiation Therapy Oncology Group (RTOG) esophageal database, 38 analyzable patients with a 1-year survival rate of 77.5% or better was needed for this trial to be deemed promising enough for development of a Phase III protocol (type I error of 0.05 and type II error of 0.20).|From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.|All eligible patients.||percentage of participants||95% Confidence Interval|Number
175885|NCT00069823|Secondary|Change in Number of Gastric Symptoms: No. of Symptoms|Mean change|Baseline to 24 Weeks|||symptoms||95% Confidence Interval|Mean
175886|NCT00069823|Secondary|Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score|Mean change. The Gastroesophageal Reflux Disease Symptom Assessment Scale score ranges from 0 to 3, with lower numbers indicating less distress.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
175887|NCT00069823|Secondary|Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component|Mean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
175888|NCT00069823|Secondary|Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component|Mean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
175889|NCT00069823|Secondary|Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)|Mean change. Scores on the Mini-Asthma Quality of Life Questionnaire (mini-AQLQ)range from 1 to 7, with higher scores indicating better quality of life and 0.5 as the minimal clinically important difference.|Baseline to 24 Weeks|||score||95% Confidence Interval|Mean
175895|NCT00069823|Secondary|Pulmonary Function: Change in Prebronchodilator FEV1|Mean change in pre-bronchodilator FEV1 - forced expiratory volume in 1 second; a measure of pulmonary function. The treatment effect is the difference in the mean change in between the groups.|Baseline to 24 Weeks|The analyses are based on data from 191 participants in the placebo group and 201 in the esomeprazole group, with the following exception: 41 participants in the placebo group and 37 in the esomeprazole group for measurement of 20% post-diluent baseline (PC20).||liters||95% Confidence Interval|Mean
175896|NCT00069823|Secondary|Night Awakening|Rate of awakening at night because of asthma symptoms|Baseline to 24 Weeks|||events per person-year|||Number
175897|NCT00069823|Secondary|Use of Rescue Medications|Increase in the use of rescue meds by 4 or more uses on a particular day above the average uses during the run-in period.|Baseline to 24 Weeks|||events per person-year|||Number
175898|NCT00069823|Secondary|Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists||Baseline to 24 Weeks|||events per person-year|||Number
175899|NCT00069823|Secondary|Exacerbation Components: New Use of Oral Corticosteroids||Baseline to 24 Weeks|||events per person year|||Number
175900|NCT00069823|Primary|Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion|Episodes of poor asthma control was defined as any one of the following: 2 consecutive days with a drop in peak flow >=30% of baseline; urgent care for asthma; or new use of oral corticosteroids for asthma|Baseline to 24 Weeks|||events per person year|||Number
175901|NCT00069823|Secondary|Exacerbation Components: Urgent Care Visit||Measured at Month 6|||events per person-year|||Number
175902|NCT00069823|Secondary|Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days||Baseline to 24 Weeks|||events per person-year|||Number
175903|NCT00069784|Other Pre-specified|Number of Patients With First Occurrence of Any Type of Cancer|Data on cancers that occurred in association with hospitalizations were collected systematically in both groups from the start of the study. All reported cancers occurring during the trial (new or recurrent) were adjudicated by the Event Adjudication Committee.|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|The analysis was based on the intent-to-treat (ITT) population.||participants|||Number
175904|NCT00069784|Other Pre-specified|Number of Patients With Various Types of Symptomatic Hypoglycemia Events|"Symptomatic hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia, based on data recorded in the participant’s diary. These were further categorized as confirmed (ie, with a concomitant home glucose reading ≤54 mg/dL [≤3.0 mmol/L]) or unconfirmed.~Severe hypoglycemia was defined as an event with clinical symptoms consistent with hypoglycemia in which the participant required the assistance of another person, and one of the following:~the event was associated with a documented self-measured or laboratory plasma glucose level ≤36 mg/dL (≤2.0 mmol/L), or~the event was associated with prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration."|on-treatment period (median duration of follow-up: 6.2 years)|The population analyzed was the safety population consisting of all randomized and treated patients (who received at least one dose of study drug) for the insulin glargine group and of all randomized patients for the standard care group.||participants|||Number
175905|NCT00069784|Secondary|Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG|The incidence was determined by calculating the proportion of randomized participants without diabetes at randomization who either developed diabetes during the study or who were classified as having possible diabetes based on results of two oral glucose tolerance tests (OGTT) performed after the last follow-up visit (within 21-28 days for OGTT#1 and within 10-14 weeks for OGTT#2).|from randomization until the last follow-up visit or last OGTT (median duration of follow-up: 6.2 years)|The analysis was based on the subgroup of the intent-to-treat (ITT) population without diabetes at randomization.||percentage of patients|||Number
175906|NCT00069784|Secondary|Composite Diabetic Microvascular Outcome (Kidney or Eye Disease)|"The composite outcome used to analyze microvascular disease progression contained components of clinical events:~the occurrence of laser surgery or vitrectomy for diabetic retinopathy (DR);~the development of blindness due to DR;~the occurrence of renal death or renal replacement therapy; as well as the following laboratory-based events:~doubling of serum creatinine; or~progression of albuminuria (from none to microalbuminuria [at least 30 mg/g creatinine], to macroalbuminuria [at least 300 mg/g creatinine])."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.~For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."||participants|||Number
175907|NCT00069784|Secondary|Total Mortality (All Causes)|Number of deaths due to any cause|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|The analysis was based on the intent-to-treat (ITT) population, which was all randomized participants, regardless of compliance with the protocol.||participants|||Number
175908|NCT00069784|Primary|Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Revascularization Procedure or Hospitalization for Heart Failure (HF)|"Number of participants with a first occurrence of one of the above events (revascularization procedures included coronary artery bypass graft, percutaneous transluminal coronary angioplasty (PTCA) i.e. balloon, PTCA with stent, other percutaneous intervention, carotid angioplasty with/without stent, carotid endarterectomy, peripheral angioplasty with or without stent, peripheral vascular surgery, and limb amputation due to vascular disease).~The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.~Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of the events) is provided in the first row of the statistical table."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.~For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."||participants|||Number
176239|NCT00062764|Secondary|Mean Increase of Insulin Sensitivity Index||48 weeks|||percentage||Standard Deviation|Mean
175909|NCT00069784|Primary|Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke|"Number of participants with a first occurrence of one of the above events.~The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants.~Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of CV death, nonfatal MI or nonfatal stroke) is provided in the first row of the statistical table."|from randomization until study cut-off date (median duration of follow-up: 6.2 years)|"The analysis was based on the intent-to-treat (ITT) population i.e. all randomized participants.~For the endpoint's composition, the numbers only summarize the event when it was the first occurrence of the endpoint. A participant is counted only once within a category. The same participant may appear in different categories."||participants|||Number
175910|NCT00069641|Secondary|Percent Change From Baseline in Mean Cardiac Left Ventricular Mass Index (LVMI) at Week 53|Cardiac LVMI was determined by echocardiography. Change was calculated at Week 53 from baseline. LVMI is the LVM, in grams indexed to BSA, in square meter [m^2]. LVMI in g/m^2 = LVM divided by BSA.|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.||percent change||Standard Error|Mean
175911|NCT00069641|Secondary|Mean Cardiac Left Ventricular Mass Index (LVMI) at Baseline|Cardiac LVMI was determined by echocardiography. LVMI is the left ventricular mass (LVM, in grams [g]) indexed to body surface area (BSA), in square meter [m^2]. LVMI (in gram per square meter [g/m^2]) = LVM divided by BSA.|Baseline|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.||gram per square meter (g/m^2)||Standard Error|Mean
175912|NCT00069641|Primary|Ranked Adjusted 2-Component Composite Variable Score Based on Change From Baseline to Week 53|The 2-component composite variable consists of the sum of the ranked changes from baseline to Week 53 for percent predicted Forced Vital Capacity (FVC) and 6-Minute Walking Test (6MWT) total distance walked. For the 2 treatment groups being compared, ranking occurred within the comparison treatment groups combined (idursulfase weekly and placebo treatment groups). These comparison groups were pooled and ranked for each component separately. Within each component (% predicted FVC, 6MWT), the change from baseline was then ranked. The lowest change value was assigned a rank of 1, the next lowest a rank of 2, etc. The composite score for each participant was the sum of the 2 ranked scores corresponding to the 2 individual components (% predicted FVC and 6MWT) for each participant. Thus, the greater the composite score (greater the sum of the ranks of the changes from baseline, where the lowest change was ranked as 1), the greater the improvement.|Baseline, Week 53|Intent-to-treat (ITT) population, Only participants receiving “Idursulfase Weekly” or “Placebo” were to be analyzed for this outcome.||sum of the ranked scores||Standard Error|Mean
175913|NCT00069641|Secondary|Change From Baseline in Mean Normalized Urine Glycosaminoglycan (GAG) Levels at Week 53|Mean normalized urine GAG was analyzed using urine testing. Change was calculated at Week 53 from baseline. The urine GAG levels were normalized to urine creatinine and were reported as microgram GAG per milligram creatinine (mcg GAG/mg creatinine).|Baseline, Week 53|ITT population.||mcg GAG/mg creatinine||Standard Error|Mean
175914|NCT00069641|Secondary|Percent Change From Baseline in Mean Combined Liver and Spleen Volume at Week 53|Liver and Spleen volume was determined by Magnetic Resonance Imaging (MRI). Change was calculated at Week 53 from baseline.|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.||percent change||Standard Error|Mean
175915|NCT00069641|Secondary|Mean Combined Liver and Spleen Volume at Baseline|Liver and Spleen volume was determined by Magnetic Resonance Imaging (MRI).|Baseline|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.||milliliter (mL)||Standard Error|Mean
175916|NCT00069641|Secondary|Change From Baseline in Mean Global Joint Range of Motion (JROM) Score at Week 53|Change was calculated at Week 53 from baseline. Global JROM (% of normal range of motion) is the average of 11 ratios multiplied by 100. Ratios are Left/Right means of passive range of motion in Shoulder (Flexion/Extension, Abduction, Internal/External Rotation), Elbow (Flexion/Extension), Wrist (Flexion/Extension), Index Finger (Flexion/Extension [Combined Metacarpophalangeal joint (MCP), Proximal interphalangeal joint (PIP), Distal interphalangeal joint (DIP) motion]), Hip (Flexion/Extension, Abduction, Internal/External Rotation), Knee (Flexion/Extension), and Ankle (Dorsiflexion) divided by the normal range (American Academy of Orthopedic Surgeons and American Medical Association).|Baseline, Week 53|ITT population. Here, number of participants analyzed = participants who were evaluable for this measure.||percentage of normal range of motion||Standard Error|Mean
175917|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||mm/hour||Standard Deviation|Mean
175918|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mm/hour||Standard Deviation|Mean
175919|NCT00069329|Primary|Erythrocyte Sedimentation Rate (ESR) Measurement|Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mm/hour||Standard Deviation|Mean
176240|NCT00062764|Secondary|Number of Patients With Impaired Glucose Tolerance After Treatment||48 weeks|||participants|||Number
175920|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||mg/dl||Standard Deviation|Mean
175921|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mg/dl||Standard Deviation|Mean
175922|NCT00069329|Primary|C-reactive Protein (CRP) Measurement|C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mg/dl||Standard Deviation|Mean
175923|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||mg/liter||Standard Deviation|Mean
175924|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mg/liter||Standard Deviation|Mean
175925|NCT00069329|Primary|Serum Amyloid A (SAA) Measurement|Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter.|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||mg/liter||Standard Deviation|Mean
175926|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||units on a scale||Standard Deviation|Mean
175927|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
175928|NCT00069329|Primary|Childhood Health Assessment Questionnaire (CHAQ)|Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
175929|NCT00069329|Primary|Parent /Patient Pain Rating|Visual Analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||units on a scale||Standard Deviation|Mean
175930|NCT00069329|Primary|Parent /Patient Pain Rating|Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
175931|NCT00069329|Primary|Parent /Patient Pain Rating|Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
175932|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||units on a scale||Standard Deviation|Mean
175933|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
175934|NCT00069329|Primary|Patient / Parent Global Score of Overall Disease Activity|Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
175935|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|60 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment.||units on a scale||Standard Deviation|Mean
175936|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|36 months|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
175937|NCT00069329|Primary|Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches)|"The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable."|Baseline|Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment.||units on a scale||Standard Deviation|Mean
175938|NCT00069277|Primary|Response and Progression Will be Evaluated in This Study Using the New International Criteria Proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in Only the Largest Diameter of the Tumor Lesions Are Used.||12 Weeks|||participants|||Number
175939|NCT00069264|Primary|Determination of the Maximum Tolerated Dose||28 Days|||mg/m^2|||Number
175940|NCT00069238|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|67 months and 9 days|||participants|||Number
175941|NCT00069238|Primary|Maximum Tolerated Dose (MTD) of Alemtuzumab|MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously every 3 weeks for up to 6 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT).|Evaluation of dose limiting toxicity was done at the end of each cycle or every 21 days.|||mg|||Number
175942|NCT00069160|Secondary|Percent Increase in Sestamibi Area Under Curve (AUC) in Tumor Tissue|99mTc-sestamibi is a radionuclide imaging agent used to study cardiac function that has also been shown to be a substrate for P-glycoprotein- mediated drug efflux. Because of the high expression of Pgp in liver tissue, sestamibi uptake in liver tissue is often monitored as a marker of Pgp inhibition. A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001.|3-24 hours|||Percent||Full Range|Median
175943|NCT00069160|Secondary|Percent Increase in Sestamibi Area Under Curve (AUC) in Liver After Tariquidar|A significant change in the area under the curve(AUC) in liver tissue (normal tissue as a surrogate) is defined as P<0.001. A secondary objective of this study was to establish whether tariquidar (150 mg) modulates Pgp in liver. Sestamibi is a Pgp substrate that may be a surrogate for measuring drug efflux from tumors. A baseline Tc-sestamibi scan was obtained before the administration of tariquidar. A minimum of 48 hours later, on or about day 22 a single dose of tariquidar was administered, followed by a second Tc-sestamibi scan.|3 - 24 hours|Percent increase in sestamibi AUC in liver after tariquidar.||percent increase in sestamibi AUC||Full Range|Median
175944|NCT00069160|Primary|Clinical Response Rate|Response is determined by RECIST criteria defined as changes in only the largest diameter (unidimensional measurement) of the tumor lesion. Lesions are either measurable or non-measurable. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/- 20 mm with conventional techniques (CT, MRI, xray) or as >/- 10 mm with a spiral CT scan. Non-measurable lesions are defined as all other lesions (or sites of disease) including small lesions (longest diameter <20 mm with conventional techniques or <10 mm using spiral CT.|4 years, 8-11 months|||Percentage of participants|||Number
175945|NCT00069160|Primary|Geometric Mean of Area Under Curve (AUC0)-24||24 hours|Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Pharmacokinetic data were evaluable in 39 patients. Paired data from 31 participants were evaluable.||h*ng/mL||95% Confidence Interval|Geometric Mean
175946|NCT00069160|Primary|The Number of Participants With Adverse Events.|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|4 yrs 8-11 months|||participants|||Number
175947|NCT00069160|Primary|Geometric Mean of Maximum Concentration of the Drug (Cmax)|In the first cycle patients were to receive docetaxel on days 1 and 8 and to be randomized to receive tariquidar on either day 1 or 8. Thus pharmacokinetic data with and without tariquidar can be compared.|24 hours|Docetaxel alone (C1D1 = 21 patients; C1D8 = 18 patients) Docetaxel with Tariquidar (C1D1 = 21 patients; C1D8 = 16 patients) Data were evaluable in 39 patients. Paired data from 31 participants were evaluable.||Cmax (ng/mL)||95% Confidence Interval|Geometric Mean
175948|NCT00069121|Secondary|Number of Participants Assesed for Adverse Events|"Adverse events were presented in individual listings and summarized by Medical Dictionary for Regulatory Activities (MedDRA)System Organ Classes, intensity, and relation to trial treatment. Laboratory data are summarized in two ways: Summary of laboratory abnormalities (regardless of the baseline values), with particular attention to the more clinically relevant Grade 3/4 laboratory abnormalities. Summary of laboratory abnormalities as a shift from baseline.~See Adverse Events module for details."|followed from Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake|Safety Population||participants|||Number
175949|NCT00069121|Secondary|Overall Survival [Time to Event]|Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.|Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos.|Intent-to-Treat Population||months||95% Confidence Interval|Median
175950|NCT00069121|Secondary|Overall Survival [Number of Events]|Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.|Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos.|Intent-to-Treat Population||participants|||Number
175951|NCT00069121|Secondary|Relapse-free Survival (RFS) [Time to Event]|Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be relapse free.|Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.|Intent-to-Treat Population||months||95% Confidence Interval|Median
175952|NCT00069121|Primary|Disease-free Survival [Time to Event]|Determination of an event was based on tumor assessments and survival follow-up assessments. Any recurrence of the original colon cancer or appearance of a new colon or rectal cancer was to be proven by cytology or histology, when possible. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.|Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.|Intent-to-Treat Population||months||95% Confidence Interval|Median
175953|NCT00069121|Secondary|Relapse-free Survival (RFS) [Number of Events]|Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer.|Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.|Intent-to-Treat Population||participants|||Number
175954|NCT00069121|Primary|Disease-free Survival (DFS) [Number of Events]|Number of patients with/without recurrence of the original colon cancer or appearance of a new colon or rectal cancer, or death due to any cause. Based on tumor assessments and survival follow-up assessments.|Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.|Intent-to-Treat Population||participants|||Number
175955|NCT00069108|Secondary|Number of Participants With Marked Post-baseline Laboratory Abnormalities by Trial Treatment|Laboratory abnormalities were defined as those values that were outside the Roche defined reference range and showed a clinically relevant change from baseline. All laboratory parameters were categorized according to the National Cancer Center Common Toxicity Criteria (NCI-CTCAE) grading system. Incidence of Grade 1 to 4 laboratory abnormalities are presented in the table below.|Up to 3 years|All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters||participants|||Number
175956|NCT00069108|Secondary|Time To Treatment Failure|Time to treatment failure was defined as the time from the date of randomization to the first occurrence of adverse event (AE), insufficient therapeutic response, death, failure to return, or refusing treatment/being uncooperative/withdrawing consent.|Up to 3 years|All participants who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin were included in the safety population. The safety population was used for the analyses of all safety parameters.||days||95% Confidence Interval|Median
176241|NCT00062764|Primary|Number of Patients With Improvement in Liver Histology|A histological response was defined as a reduction in the NASH activity index by 3 points or more with improvements of at least 1 point each in steatosis, parenchymal inflammation, and hepatocellular injury.|48 weeks|||participants|||Number
175957|NCT00069108|Secondary|Duration Of Response|Duration of response (DOR) is defined as the time when CR or PR was first met up to first date that PD or death is documented. CR is defined as disappearance of all TLs and non TLs, PR is defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD. PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions for the TLs or the appearance of one or more new lesions and/or unequivocal progression of existing non-TLs.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the Intent-to-treat (ITT) population. Participants in this population were analyzed according to the arm to which they were randomized.||days||95% Confidence Interval|Median
175958|NCT00069108|Secondary|Time To Response|Time to response (TOR) (best response of CR or PR) was measured as the time from randomization to the first date on which the measurement criteria for CR or PR (whichever status was recorded first) were met. CR for TLs was defined as disappearance of all TLs and for non-TLs as disappearance of all non-TLs and normalization of tumor marker level. PR was defined as at least 30% decrease in the sum of the LD of TLs, taking as reference the baseline sum LD.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.||participants|||Number
175959|NCT00069108|Secondary|Overall Survival|Overall survival was measured as the time from the date of randomization to the date of death. Participant who were not reported to have died at the time of the analysis were censored using the date they were last known to be alive.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.||days||95% Confidence Interval|Median
175960|NCT00069108|Secondary|Best Overall Response, Independent Review Committee Assessment|Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include CR, PR, or SD. CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks, for SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks. This PFS evaluation was based on Independent Review Committee Assessment.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.||participants|||Number
175961|NCT00069108|Secondary|Best Overall Response, Investigators’ Assessments|Best overall response is best response recorded from start of treatment until disease progression/recurrence where responses include complete response (CR), partial response (PR), or stable disease (SD). CR was defined as disappearance of all TLs, non-TLs along with normalization of tumor marker level. PR is at least 30% decrease in sum of the LD of TLs, taking as reference baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking reference of smallest sum LD since treatment started. It was dependent on achievement of measurement and confirmation criteria. BOR .i.e. CR or PR was confirmed by repeat assessments performed within 4 weeks. For SD, follow-up assessments had to meet the SD criteria at least once after study entry within 6 to 8 weeks.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the ITT population. Participants in this population were analyzed according to the arm to which they were randomized.||participants|||Number
175962|NCT00069108|Secondary|Progression Free Survival Based on Treatment Analysis- Per Population|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization|Up to 3 years|The PP population included randomized participants who received at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments.||days||95% Confidence Interval|Median
175963|NCT00069108|Secondary|Progression Free Survival Based on Treatment Analysis- Intent To Treat Population|Progression free survival (PFS) is defined as the time from date of randomization to day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. PFS was analyzed using an on-treatment approach included only disease progression and death that occurred no later than 28 days after the last confirmed intake of study medication in the primary study treatment phase.|Up to 3 years|All participants who were randomized to one of the two study arms were included in the Intent To Treat (ITT) population. Participants were analyzed according to the arm to which they were randomized.||days||95% Confidence Interval|Median
176007|NCT00068380|Primary|Toxicity in Terms of Type (Organ Affected or Laboratory Determination Such as Absolute Neutrophil Count), Severity (by NCI Common Toxicity Criteria and Nadir or Maximum Values for the Laboratory Measures), Time of Onset, Duration, and Reversibility|Tables will be created to summarize these toxicities by type and severity. Baseline information (e.g. the extent of prior therapy) and demographic information will be presented, as well, to describe the patients treated in this Phase II study.|Up to 30 days post treatment||||||
175964|NCT00069108|Secondary|Progression Free Survival Based on Independent Review Committee Assessment|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the RECIST version 1.0, wherein PD was defined as at least a 20% increase in the sum of the LD of the TLs, taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-TLs. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization. This PFS evaluation was based on Independent Review Committee Assessment.|Up to 3 years|PP population excluded randomized participants who did not receive at least one dose of Capecitabine, 5-FU, or Oxaliplatin, or who had a major violation of protocol inclusion or exclusion criteria.||days||95% Confidence Interval|Median
175965|NCT00069108|Primary|Progression Free Survival|Progression free survival (PFS) is defined as the time from the date of randomization to the day of documented disease progression or death from any cause. It was based on tumor assessments made according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0, wherein progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions (TLs), taking as reference the smallest sum LD recorded since the treatment started or appearance of one or more new lesions or unequivocal progression of existing non-target lesions. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment confirming that they had not progressed. Participants with no tumor assessments after baseline but who were still alive at the time of the clinical cut-off were censored at date of randomization|Up to 3 years|The per protocol (PP) population included randomized participants who received at least one dose of capecitabine, 5-FU, or oxaliplatin, or who did not had a major violation of protocol inclusion or exclusion criteria assessments.||days||95% Confidence Interval|Median
175966|NCT00069095|Secondary|Duration of Complete Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
175967|NCT00069095|Secondary|Duration of Complete Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|For complete responders, the duration of complete response was measured from the time measurement criteria were first met for complete response until the date that progressive disease (or death) was documented. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
175968|NCT00069095|Secondary|Duration of Overall Response as Assessed by the Investigator According to RECIST: Superiority Analysis of Chemotherapy Plus Bevacizumab Versus Chemotherapy Alone|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
175969|NCT00069095|Secondary|Duration of Overall Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date when progressive disease or death was documented. It was based on tumor assessments made by the investigators according to the RECIST criteria. Participants who neither progressed nor died were censored at the date of the last tumor assessment. Participants undergoing surgical resection with curative intent were censored at the date of surgery. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
175970|NCT00069095|Secondary|Time to Response as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Week 1 to Week 54|The ITT population included all randomized participants who provided written informed consent.||Participants|||Number
175971|NCT00069095|Secondary|Time to Response as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|For participants whose BOR was CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status was recorded first) was met. It was based on tumor assessments made by the investigators according to the RECIST criteria. Results were reported as the number of participants achieving a response in 8 time categories from Week 1 to Week 54. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Week 1 to Week 54|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||Participants|||Number
175972|NCT00069095|Secondary|Time to Treatment Failure as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach included all tumor assessments or deaths that occurred during the primary study treatment phase, the post-study treatment phase, or the follow-up phase. The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
175973|NCT00069095|Secondary|Time to Treatment Failure (TTF) as Assessed by the Investigator According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|Time to treatment failure was defined as the time from the date of randomization to the date of discontinuation of the primary study treatment phase due to adverse event/intercurrent illness, insufficient therapeutic response, death, failure to return, refusing treatment/being unwilling to cooperate, or withdrawing consent; discontinuation of the post study treatment phase due to adverse event, progressive disease, death, participant refusal/administrative reasons, or withdrawing consent; documented disease progression; or death due to any cause, whichever occurred first. The general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase.The on-treatment approach included only tumor assessments and deaths that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase only.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The safety population included all participants who were randomized and received at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
175974|NCT00069095|Secondary|BOR as Assessed by the IRC According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||Percentage of responders|||Number
175975|NCT00069095|Secondary|BOR as Assessed by the IRC According to RECIST: Non-inferiority of XELOX Versus FOLFOX-4|According to the RECIST criteria, the BOR in an individual participant was the best response recorded from the start of the treatment until disease progression/recurrence (taking the smallest measurements recorded since the baseline assessment as a reference for PD). The BOR as assessed by the IRC was determined based on tumor assessments that were made up to and including 28 days after last intake of study medication in the primary study treatment phase. Responders were defined as the percentage of participants with a complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||Percentage of responders|||Number
175976|NCT00069095|Secondary|Best Overall Response (BOR) as Assessed by the Investigator According to RECIST: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||Percentage of responders|||Number
175977|NCT00069095|Secondary|Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST): Non-inferiority of XELOX Versus FOLFOX-4|According to the RECIST criteria, BOR in an individual participant was defined as the best response recorded from the start of the treatment until disease progression or recurrence. Only tumor assessments as assessed by the investigator and made up to and including 28 days after last intake of study medication in the primary study treatment phase not later than date of first curative surgery were included in these analyses. Responders were defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR). Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|From baseline until disease progression/recurrence, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||Percentage of responders|||Number
176008|NCT00068380|Primary|Response Rate|Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by X-Ray, MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|Up to 6 years|||percentage of patients responding|||Number
176009|NCT00068237|Secondary|Overall Survival||From registration to date of death or last follow-up||||||
175978|NCT00069095|Primary|PFS as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
175979|NCT00069095|Secondary|Overall Survival: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
175980|NCT00069095|Secondary|Overall Survival: Non-inferiority of XELOX Versus FOLFOX-4|Overall survival was defined as the time from the date of randomization to the date of death. Participants who were not reported to have died at the time of the clinical cut-off date for the analysis were censored using the date they were last known to be alive. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
175981|NCT00069095|Secondary|PFS by General Approach, Participants With Curative Surgery Not Censored: Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the BV-containing arms was compared with the chemotherapy alone arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
175982|NCT00069095|Secondary|PFS by General Approach, Participants With Curative Surgery Not Censored: Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants who underwent curative surgery after experiencing a sufficient shrinkage of their tumor were not censored at the date of surgery, but any relapse, new occurrence of colorectal cancer, or death was considered as an event. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
175983|NCT00069095|Secondary|PFS (On-treatment Approach): Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
175984|NCT00069095|Secondary|PFS (On-treatment Approach): Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. The on-treatment analysis included only tumor assessments and death events that occurred no later than 28 days after the last confirmed intake of any study medication in the primary study treatment phase. Participants who did not have an event during this interval were censored at the date of the last tumor assessment within this time window, or on day 1 if no tumor assessment was available after baseline. Participants who underwent surgical resection with curative intent without prior progression within 28 days after the last confirmed intake of any study medication in the primary study treatment phase were censored at the date of surgery. The on-treatment approach excluded the possible impact of other treatments that might have been started before disease progression. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
175985|NCT00069095|Secondary|PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Superiority of Chemotherapy Plus BV Over Chemotherapy Alone|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Superiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Superiority of the bevacizumab-containing arms was compared with the placebo-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The ITT population included all randomized participants who provided written informed consent.||days||95% Confidence Interval|Median
175986|NCT00069095|Secondary|PFS as Assessed by the Independent Review Committee (IRC) (General Approach, Participants With Curative Surgery Censored) - Non-inferiority of XELOX Versus FOLFOX-4|PFS is defined as the time from randomization to disease progression (PD) or death due to any cause. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was analyzed on the basis of the tumor response assessments made by the IRC. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms was compared with the FOLFOX-4-containing arms.|Baseline until disease progression or death, approximately 2 years 6 months|The EPP excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
175987|NCT00069095|Primary|Progression-free Survival (PFS) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) by General Approach (Participants With Curative Surgery Censored): Non-inferiority of XELOX Versus FOLFOX-4|PFS was defined as the time from randomization to progressive disease or death. Participants with neither disease progression nor death were censored at the last date of the last tumor assessment that confirmed that their disease had not progressed. Participants with no tumor assessments after baseline who were alive at the time of clinical cutoff were censored at the date of randomization. Participants who underwent surgical resection with curative intent without prior progression were censored at the date of surgery. PFS was based on tumor assessments made by the investigators according to the RECIST criteria. Non-inferiority analysis that followed the general approach took into account all tumor assessments obtained during the primary study treatment phase, the post-study treatment phase and those obtained during the follow-up phase. Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4- containing arms was investigated.|Baseline until disease progression or death, approximately 2 years 6 months|The eligible patient population (EPP) excluded participants from the ITT who had violated major protocol inclusion or exclusion criteria or participants who were randomized and did not receive at least one dose of capecitabine, 5-FU, oxaliplatin, or bevacizumab/placebo.||days||95% Confidence Interval|Median
175988|NCT00068822|Primary|Patient's Rating of Average Pain at 1 Month|Patient's rating of average pain intensity during the preceding 24 hours at 1 month. The rating scale was from 0 to 10, with higher scores indicating more severe pain.|1 month|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.||units on a scale||Standard Deviation|Mean
175989|NCT00068822|Secondary|Patient Well-being at 1 Month|"Patient well-being was quantified by these tools: Health status outcome using Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36), version 2. Subjects completed the SF-36 which consists of 8 sub-scales which are additionally summarized into 2 summary components (physical and mental). The subscales and the summary scales both range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).~Pain Frequency Index, Pain Bothersome Index (scores range from 0-4, higher scores indicating more severe pain).~European Quality of Life (QOL) 5 Dimensions (EQ-5D), scale range -0.1 to 1.0; higher scores indicating a better QOL.~Study of Osteoporotic Fractures-Activities of Daily Living (SOF ADL6) range from 0 to 18; higher scores = more back-related disability."|Month 1|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.||units on a scale||Standard Deviation|Mean
175990|NCT00068822|Primary|Back-specific Functional Status Using Roland-Morris Disability Questionnaire (RDQ) Scale at 1 Month|Back-specific functional status using RDQ scale range from 0 (no pain) to 23, with higher scores indicating more severe disability.|1 month after procedure|68 subjects were randomized to undergo vertebroplasty and 63 to undergo the control intervention. All underwent the assigned intervention. One subject in the vertebroplasty group and two subjects in the control group were lost to follow-up before 1 month.||units on a scale||Standard Deviation|Mean
175991|NCT00068770|Secondary|Overall Survival|duration of survival when celecoxib is administered concurrently with radiation in pts with newly diagnosed glioblastoma multiforme|date pt started treatment to date pt last known alive|latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group||months||95% Confidence Interval|Mean
175992|NCT00068770|Primary|Effects of Hepatic Enzyme Inducing Drugs Such as Anticonvulsants, on the PK of Celecoxib|subjects will take one dose of celecoxib and will then have 6 hours of blood draws, day 2 subject will take 2 doses of celecoxib 8 hours apart with 2 additional blood samples, one hour apart. Subject, will continue to take 2 doses of celecoxib for 6 weeks, with a sample (PK) drawn every week prior to the first dose of the week. Comparison of Cmax of Celecoxib is reported|First dose of celecoxib through completion of radiation, 6 weeks.|"pts who had PK data for the first dose of celecoxib. observations were excluded if sample was not collected within 12 +/- 2h after taking prior dose, was drawn after dosing on same day or determine to be outlier by dixon's test.~PK data was available for 15 pts in the +EIASD group and 12 pts in the -EIASD group"||(ng/ml)||Standard Deviation|Geometric Mean
175993|NCT00068588|Primary|Response Rate of a Combination of GTI-2040 and Capecitabine|Following the dose escalation step, additional patients will be accrued at the MTD and evaluated for disease response using RECIST v1.0 criteria. Patients with confirmed complete or partial response are considered to have responded favorably to treatment.The sample size and early stopping for futility was governed by a two stage Optimum design suggested by Simon. It was assumed that a true response rate less than 25% would not warrant further study of this agent. It was also assumed that a response rate of 45% would be considered promising. In the first stage (following the dose escalation step), 15 evaluable patients were treated. Four or fewer observed responses, would stop accrual, while 5 or more observed would continue accrual for an additional 12 patients during the second stage of the study. Ten or more responses out of 27 patients will be considered evidence warranting further study of the regimen providing toxicity and survival also appear favorable.|Up to 6 years|Response Rate was only assessed at the determined MTD. Additional patients were accrued to determine treatment efficacy at the MTD.||percentage of patients responding|||Number
175994|NCT00068588|Primary|Maximum Tolerated Dose Determined by Dose-limiting Toxicities|1st 3 pts will be treated on arm 2. If 0/3 DLTs observed, the dose will be escalated to arm 3. If 1/3 DLTs onserved on arm 2, 3 more pts will be treated on arm 2. If no additional DLTs are observed on arm 2, the dose will be escalated to arm 3. If at most 1/6 DLTs observed on arm 3, arm 3 will be considered the MTD. If more than 1/6 DLTs observed on arm 3, the dose will be de-escalated to arm 2. If at most 1/6 DLTs observed on arm 2, arm 2 will be considered the MTD. If more than 1/6 pts on arm 2 experience a DLT, the dose will be de-escalated to arm 1. The remaining pts will be treated on arm 1 as the MTD, unless more than 1/6 DLTs, in which case the study will stop. DLT is defined as any grade III or IV non-hematologic toxicity (incl. diarrhea w\ adequate antidiarrheal treatment & hydration & nausea/vomiting w\ maximal antiemetic prophylaxis, as per protocol) or grade IV hematologic toxicity. DLT will be based on the 1st course of treatment according to the revised NCI CTC v 2.0|21 days|||Patients experiencing DLT|||Number
175995|NCT00068575|Primary|Median Overall Survival (OS)|Overall Survival defined overall survival time, measured from date of tissue diagnosis till disease progression or death.|Participants followed till disease progression or death (approximately 6 years)|Analysis by protocol.||months||95% Confidence Interval|Median
175996|NCT00068419|Secondary|Changes in Magnetic Resonance Imaging (MRI) Signal Features|MRI must include images in at least two planes with (a) pre-contrast images with the following pulse sequences T-1 weighted, fast spin echo T-2 weighted with fat saturation, and a short tau inversion recovery (STIR); and (b) post-contrast images with T-1 weighted pulse sequence with fat suppression.|From baseline to up to 5 years||||||
175997|NCT00068419|Secondary|Tumor Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST)||Up to 5 years||||||
175998|NCT00068419|Secondary|Toxicity as Assessed by the National Cancer Institute Common Toxicity Terminology for Adverse Events v3.0||Up to 12 months||||||
175999|NCT00068419|Primary|Event-free Survival|Two-year event-free survival (EFS). Events include disease progression (increase in the greatest product of 2 perpendicular diameters of any lesion by > 25% or new biopsy-proven lesions), and death in absence of disease progression. Reported as Kaplan-Meier estimate of two-year EFS proportion.|Study enrollment until time of disease progression or death as a first event (maximum follow-up 5 years)|All eligible patients.||percentage of participants||95% Confidence Interval|Number
176000|NCT00068393|Secondary|Progression-free Survival|Progression-free survival is defined as time from study entry until disease progression or death from any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions.|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.||Months||95% Confidence Interval|Median
176001|NCT00068393|Secondary|Overall Survival|Overall survival is defined as the time from study entry until death from any cause.|Every 2 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.||Months||95% Confidence Interval|Median
176002|NCT00068393|Primary|Response Rate by Solid Tumor Response Criteria (RECIST)|Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR|Every 8 weeks during treatment; then every 3 months if <2 years from study entry; then every 6 months if 2-3 years from study entry|Only eligible and treated patients are included in this analysis.||Percentage of Participants||90% Confidence Interval|Number
176003|NCT00068380|Primary|Baseline Gene Expression Levels of the Target Genes (PDGF-R and PDGF), Genes Associated With Induction of Apoptosis (Bcl-2, Bax), and Cell Cycle Regulatory Genes (p53, p21, p27|Will summarized overall and according to response and toxicity (if numbers permit), using medians, quartiles and ranges – or if a transformation is found to render the data compatible with the normal assumptions, with means, standard deviations, and confidence intervals. The association with progression-free survival or overall survival will be assessed by dichotomizing the measures of gene expression at the median (or by previously established cut-points) and constructing Kaplan-Meier plots.|Baseline||||||
176004|NCT00068380|Primary|Time to Progression|Will be summarized using the Kaplan-Meier product-limit estimators.|From first day of treatment to the first observation of disease progression or death due to disease, assessed up to 6 years||||||
176005|NCT00068380|Primary|Overall Survival|Will be summarized using the Kaplan-Meier product-limit estimators.|From first day of treatment to time of death due to any cause, assessed up to 30 days post-treatment||||||
176006|NCT00068380|Primary|Progression-free Survival||From first day of treatment to the first observation of disease progression or death due to any cause, assessed up to 30 days post treatment||||||
176010|NCT00068237|Secondary|Disease-free Survival||From registration to date of failure (local or regional persistence/relapse or distant metastasis or second primary tumor or death) or last follow-up||||||
176011|NCT00068237|Secondary|Toxicity||From start of treatment to last follow-up||||||
176012|NCT00068237|Secondary|Quality of Life||From registration to 1 year||||||
176015|NCT00068237|Primary|"Number of Patients Scored as Having the Surgical Technique of Submandibular Salivary Gland Transfer Performed Per Protocol"|"Surgery will be scored as per protocol prescription if scored as such by both central reviewers- the Study Chair and the Radiation Therapy Oncology Group Head and Neck Committee Surgical Chair. If 21 or more of 43 subjects are scored as having surgery per protocol prescription, then the technique will be considered reproducible with 80% power and 5% type I error using Simon's two stage design with unacceptable/acceptable rates set at 60%/80%."|At the time of the submandibular salivary gland transfer|Eligible patients who started study treatment.||participants|||Number
176016|NCT00068107|Secondary|Doppler Skin Blood Flow||10 years|Doppler skin blood flow was not collected in this study because it was judged to not be useful early in the study.|||||
176017|NCT00068107|Secondary|Quantitative Sensory Testing|For quantitative sensory testing, the outcome variable (detection threshold score) was analyzed for all combinations of location (foot, hand, and thigh) and test (cold, vibration, and warm). Possible threshold scores may range from 1-25. Score values of “>25” were set to 25. Higher scores indicate higher sensory detection threshold. Therefore, lower score is better. Time, measured in years, was centered at the date in which patients switched treatment regimen. All available measurements were used. A linear mixed model analysis was used to test for differences in the linear association between time and detection threshold score pre-and-post ERT regiment change while accounting for the correlation among observations from the same individual. Specifically, the model contained a subject specific random intercept with year as a fixed effect and knot at time of the treatment change.|pre-study was 2-4 years, during study sensory testing measured for approx. 4.5-5 years|Number of participants with a sufficient number of data points to estimate slope||units on a scale/year||Standard Error|Mean
176018|NCT00068107|Secondary|Number of Participants With a Change in Quantitative Sudomotor Axon Reflex Test|Quantitative sudomotor axon reflex test (QSART) is a measure of sweat function|Baseline and last observation (up to 10 years)|||participants|||Number
176019|NCT00068107|Secondary|Globotriaosylceramide (Gb(3)) in Urine Sediment||Baseline and last observation (up to 10 years)|||nanomole/(gram of Creatinine)|||Number
176020|NCT00068107|Secondary|Globotriaosylceramide (Gb(3)) in Plasma||Baseline and last observation (up to 10 years)|||nanomole/mL|||Number
176021|NCT00068107|Primary|Estimated Glomerular Filtration Rate (eGFR)|The rate of decline in renal function, as measured by estimation of glomerular filtration rate at baseline when participants were receiving agalsidase alfa (Relagal) every 2 weeks and when participants were receiving weekly infusion of Relagal.|Relagal was administered every 2 weeks for 2-4 years pre-study, Relagal was administred weekly during the study (approx. 4.5-10 years)|||ml/min/month||Standard Deviation|Mean
176022|NCT00067808|Primary|Participant Responses|Objective responses by International Working Group criteria: 'Complete Response' (CR) defined as Normalization of the peripheral blood and bone marrow with <5% bone marrow blasts, a peripheral blood granulocyte count > (1.0 x 109/ L, and a platelet count > 100 x 109/L); 'Other Response' including Partial Remission (PR) defined as above, except for the presence of 6-15% marrow blasts, or 50% reduction if <15% at start of treatment combined with participants who meet all criteria for CR except for platelet recovery to >100 x 109/L; and 'No Response'.|Response to treatment after 8 weeks of therapy|As treated: 124 patients completed treatment.||Participants|||Number
176023|NCT00067470|Secondary|Change From Baseline in Urinary GAG (uGAG) at 24 Weeks|Glycosaminoglycan (GAG) level measured in urine|baseline and 24 weeks|Baseline uGAG level was measured for 19 rhASB-treated subjects and 20 placebo-treated subjects. However, uGAG levels at 24 weeks were measured for 19 rhASB-treated subjects and 19 placebo-treated subjects, because 1 placebo-treated subject withdrew from the study before week 24.||micrograms per mg creatinine||Standard Deviation|Mean
176024|NCT00067470|Secondary|Change From Baseline in 3-minute Stair Climb at 24 Weeks|Number of stairs climbed per minute in 3 minutes at 24 weeks minus number of stairs climbed per minute in 3 minutes at baseline|baseline and 24 weeks|The efficacy analysis included all subjects except one from the placbo group who withdrew from the study prior to the week 24 assessment.||stairs/min||Standard Deviation|Mean
176025|NCT00067470|Primary|Change From Baseline in 12-minute Walk Test at 24 Weeks|Number of meters walked in 12 minutes at week 24 minus number of meters walked in 12 minutes at baseline|baseline and 24 weeks|The efficacy analysis included all subjects except one from the placebo group who withdrew from the study prior to the week 24 assessment.||meters||Standard Deviation|Mean
176026|NCT00067236|Primary|Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi in mL/m2) at Day 90 Post Myocardial Infarction (MI)|Mean change of left ventricular end diastolic volume index (mL/m2) as evaluated via ventricular end-diastolic volume index augmentation 90 days post Myocardial Infarction (MI)|90 days|A patient was considered evaluable for the primary efficacy assessment if data were complete for at least the baseline and Day 90 visit (i.e., no data were imputed for the primary endpoint).||mL/m2||Standard Error|Mean
176027|NCT00066963|Primary|Number of Caries Incident Cases|A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.|two years|intention-to-treat with any follow-up information. multiple imputation for sensitivity analyses.||participants|||Number
176028|NCT00066807|Secondary|Sites of First Treatment Failure||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.|||||
176029|NCT00066807|Secondary|Systemic Disease-free Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.|||||
176030|NCT00066807|Secondary|Overall Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.|||||
176031|NCT00066807|Primary|Disease-free Survival||For first time at a median follow up approximately 5 years|The trial was terminated early due to poor accrual. No outcome measure data is available.|||||
176050|NCT00066365|Primary|Feasibility Success|Feasibility success defined as received 21 days of protocol therapy, did not experience grade III or grade IV toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 3 and rendered surgically free of disease in the lungs.|Enrollment through 21 days of protocol therapy|This outcome measure was calculated for eligible patients only. This yields 27 patients for assessment of this measure in Group 1 and 16 patients for assessment of this measure in Group 2.||participants|||Number
176032|NCT00066742|Secondary|Progression-Free Survival|Progression was defined as a >= 20% increase in the sum of longest diameters of measurable lesions over the smallest sum observed or unequivocal progression of non-measurable disease or the appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring discontinuation of treatment. Progression-free survival was defined as the time from the date of enrollment until the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.|At end of concurrent chemoradiotherapy (Week 8), then at end of consolidation chemotherapy (Week 15). After off treatment, every 3 months for the first 2 years then every 6 months for up to 3 years after enrollment.|||months||95% Confidence Interval|Median
176033|NCT00066742|Secondary|Response Rate (Confirmed and Unconfirmed Complete and Partial Responses Per RECIST) in the Subset of Patients With Measurable Disease at Baseline.|A complete response (CR) was defined as a complete disappearance of all disease with no new lesions. A partial response (PR) was defined as at least a 30% decrease under baseline of the sum of longest diameters of all target measurable lesions with no unequivocal progression of non-measurable disease and no new lesions. Both CR and PR had to be confirmed by a second determination at least 4 weeks apart. All disease had to be assessed using same method as baseline. Only patients with measurable disease at baseline were included in this analysis.|After completeion of concurrent chemotherapy+radiation (Week 8); then after completion of consolidation chemotherapy (Week15); once off treatment, every 3 months until disease progression for a maximum of 3 years after enrollment.|Only eligible patients who received protocol treatment were included in the analysis.||participants|||Number
176034|NCT00066742|Primary|Overall Survival|Overall survival was defined as the time from date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last conatct. Patients were followed for a maximum of 3 years from the date of enrollment.|Weekly during protocol treatment, then every 3 months for first year, then every 6 months for up to 3 years after enrollment.|Only eligible patients who received protocol treatment were included in the analsysis.||months||95% Confidence Interval|Median
176035|NCT00066703|Secondary|Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|5-year estimates||12/2017||||
176036|NCT00066703|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up|5-year estimates reported at a median follow-up of 72 months|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
176037|NCT00066703|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimate reported at a median follow-up of 72 months|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
176038|NCT00066703|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow up.|5-year estimate reported at a median follow-up of 72 months|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
176039|NCT00066690|Secondary|Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|5-year estimates||06/2017||||
176040|NCT00066690|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
176041|NCT00066690|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
176042|NCT00066690|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.|5-year estimates, reported at a median follow-up of 67 months.|Intention-to-treat||percentage of participants||95% Confidence Interval|Number
176043|NCT00066573|Secondary|Cardiovascular Morbidity and Mortality||8 years||||||
176044|NCT00066573|Secondary|Clinical Fracture Rate||8 years||||||
176045|NCT00066573|Secondary|New Primary Breast Cancer||8 years||||||
176046|NCT00066573|Secondary|Distant Disease-free Survival||8 years||||||
176047|NCT00066573|Secondary|Overall Survival||8 years||||||
176048|NCT00066573|Primary|Event-free Survival|Event free survival, the primary endpoint of this study, is defined as the time from randomization to the time of documented locoregional or distant recurrence, new primary breast cancer, or death from any cause.|5 years|||percentage of participants||95% Confidence Interval|Number
176049|NCT00066469|Primary|Event-free Survival|Alive in continuous complete remission with functioning original allograft. The Event Free Survival (EFS) will be estimated by the Kaplan-Meier method.|2 years|One patient out of the 55 patients enrolled was ineligible for study and therefore was excluded from analysis.||percentage of participants analyzed||95% Confidence Interval|Number
176051|NCT00066365|Primary|Event Free Survival (EFS)|EFS defined as the time from enrollment on the study until disease progression, occurrence of a second malignant neoplasm (SMN), death or last contact, whichever comes first. Disease progression, occurrence of a SMN or death will be considered an analytic even. In all other cases, the patient will be considered censored at last contact.|Time of enrollment to Event or 5 years from enrollment, whichever occurs first|There were 4 ineligible unilateral patients and 2 ineligible bilateral patients not included in this analysis.||years||95% Confidence Interval|Median
176052|NCT00066365|Primary|Clusterin Status in Post Chemotherapy Sample||29 days after start of protocol therapy|This outcome measure was evaluated in 30 patients, 20 patients in the unilateral recurrence group and 10 patients in bilateral recurrence group.||participants|||Number
176053|NCT00066365|Primary|Clusterin Status in Pre Chemotherapy Sample|The protein encoded by this gene can under some stress conditions also be found in the cell cytosol. It has been suggested to be involved in several basic biological events such as cell death, tumor progression, and neurodegenerative disorders.|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were measured from the bilateral recurrence group.||participants|||Number
176054|NCT00066365|Primary|S100 Status in Post Chemotherapy Sample|"The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation."|29 days after start of protocol therapy|20 patients from the unilateral recurrence group and 10 patients from the bilateral recurrence group were evaluated for this outcome measure.||participants|||Number
176055|NCT00066365|Primary|S100 Status in Pre Chemotherapy Sample|"The S-100 proteins are a family of low-molecular-weight proteins characterized by two calcium-binding sites that have helix-loop-helix (EF-hand type) conformation."|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.||participants|||Number
176056|NCT00066365|Primary|CD1a Status in Post Chemotherapy Sample|CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.|29 days after start of protocol therapy|20 patients were evaluated for this outcome measure from the unilateral group and 7 patients were evaluated from the bilateral group.||participants|||Number
176057|NCT00066365|Primary|CD1a Status in Pre Chemotherapy Sample|CD1a (Cluster of Differentiation 1a) is a human protein encoded by the CD1A gene, presence is measured by positivity.|29 days after start of protocol therapy|Patients enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 7 patients were evaluated from the bilateral recurrence group.||participants|||Number
176058|NCT00066365|Primary|FAS Status in Post Chemotherapy Sample|FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.||participants|||Number
176059|NCT00066365|Primary|FAS Ligand in Post Chemotherapy Sample|FAS ligand or FASL is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|22 patients from the unilateral recurrence group and 13 patients from the bilateral recurrence group were evaluated for this outcome measure.||participants|||Number
176060|NCT00066365|Primary|Presence of FAS in Pre-chemotherapy Sample|FAS/APO-1 is a transmembrane receptor. The presence is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|Patients who were enrolled in Group 1 (unilateral recurrence) do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment.||participants|||Number
176061|NCT00066365|Primary|Status of FAS Ligand in Pre-chemotherapy Sample|FAS ligand (FASL) is a homotrimeric type II transmembrane protein expressed on cytotoxic T lymphocytes. The Cluster of Differentiation 1a (CD1a) status is measured in Immunohistochemistry (IHC) categories.|29 days after start of protocol therapy|Patients who were enrolled in the unilateral recurrence group do not contribute to the assessment of any “Pre Chemotherapy” analysis. Such patients only had tissue for assessment after the first thoracotomy which was planned for 22 days after the start of sargramostim treatment. 14 patients were evaluated for this primary outcome measure.||participants|||Number
176062|NCT00066222|Secondary|Response Rates (Complete Response, Partial Response, Progressive Disease and Stable Disease)||From the start of treatment to 2 months following the completion of chemotherapy||||||
176063|NCT00066222|Secondary|Rate of Treatment Related Fatalities at 2 Years||From the start of treatment to 2 years||||||
176064|NCT00066222|Secondary|Rate of Acute Treatment Related Grade 3 or 4 Esophagitis||From start of radiation therapy until 90 days following the start of radiation therapy||||||
176065|NCT00066222|Secondary|Progression-free Survival at 1 Year and Median Survival Time||From randomization to date of progression, death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.||||||
176066|NCT00066222|Secondary|Overall Survival at 1 Year and Median Overall Survival||From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 1 year.||||||
176084|NCT00065806|Secondary|Change in Mean-Max Internal CIMT|For each side and wall of the internal carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right internal near wall max, right internal far wall max, left internal near wall max and left internal far wall max). These summary variables were then averaged to estimate a single mean-max internal CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176242|NCT00062751|Secondary|24-hour Trough Concentration (C Trough)|C trough in whole blood measured as nanograms per milliliter (ng/mL).|Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12|ITT; Final analysis was not conducted.||ng/mL||Standard Deviation|Mean
176067|NCT00066222|Primary|Overall Survival at 2 Years|Survival time is defined as time from study registration to the date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 2 years. This study was designed to detect an improvement in the 2-year overall survival rate from 47% to 60%. Using a one-group chi-square test with a one-sided significance level of 0.10, a sample of 67 patients was deemed sufficient to detect the difference between the null hypothesis (Ho: P .47) and the alternative hypothesis (Ha: P .60) with 80% power.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.|All eligible patients who started study treatment.||percentage of participants||95% Confidence Interval|Number
176068|NCT00066170|Primary|Daytime Sleep Latency as Measured by the Maintenance of Wakefulness Test (MWT)|The Maintenance of Wakefulness Test consisted of four 20 minute tests of the patient's ability to remain awake in soporific conditions. The Mean change from baseline to week 8 in the average MWT number of minutes until sleep onset was the primary endpoint.|Baseline to Week 8|||Minutes||Standard Deviation|Mean
176069|NCT00066066|Primary|Change in Mean Clinical Attachment Level.|Periodontal diseases are clinically diagnosed by assessments of gingival inflammation and measurements of tissue destruction. The damage to the apparatus of support of the teeth is quantified using measurements of probing pocket depth (PD) and clinical attachment level (CAL). These measurements are obtained using a periodontal probe which is introduced into the gingival sulcus to determine the distance in millimeters from the gingival margin to the depth of the sulcus or pocket (PD). Since the gingival margin fluctuates in response to inflammation (hyperplasia) or might recede, a more accurate measure of loss of attachment is obtained using the CAL, which measures the distance from a “fixed” landmark on the tooth such as the cemento-enamel junction to the depth of the pocket. Changes in CAL from baseline were used to assess results obtained with the treatment of periodontal diseases.|Baseline, 3, 6 and 12 months|Of the 146 subjects, 117 were included in the analysis, who had 2 or fewer missing monitoring visits. 84 subjects had complete data, 23 subjects had one missing visit and 10 subjects had 2 missing visits. For the 33 subjects with missing visits, data were carried forward. 68 subjects were non smokers and 49 subjects were current smokers.||mm||Standard Error|Mean
176070|NCT00065806|Secondary|Change in Homocysteine||Change from baseline to 36 months|||μmoles/liter||95% Confidence Interval|Mean
176071|NCT00065806|Secondary|Change in Lipoprotein A||Change from baseline to 36 months|||mg/dl||95% Confidence Interval|Mean
176072|NCT00065806|Secondary|Change in Triglycerides||Change from baseline to 36 months|||mg/dl||95% Confidence Interval|Mean
176073|NCT00065806|Secondary|Change in LDL Cholesterol||Change from baseline to 36 months|||mg/dl||95% Confidence Interval|Mean
176074|NCT00065806|Secondary|Change in HDL Cholesterol||Change from baseline to 36 months|||mg/dl||95% Confidence Interval|Mean
176075|NCT00065806|Secondary|Change in Total Cholesterol||Change from baseline to 36 months|||mg/dl||95% Confidence Interval|Mean
176076|NCT00065806|Secondary|Change in Natural Log of mg/L for hsCRP||Change from baseline to 36 months|||natural log of mg/L||95% Confidence Interval|Mean
176077|NCT00065806|Secondary|Change in Mean-Mean Near Wall CIMT|For the near wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common near wall mean, right bifurcation near wall mean, right internal near wall mean, left common near wall mean, left bifurcation wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176078|NCT00065806|Secondary|Change in Mean-Max Near Wall CIMT|For the near wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common near wall max, right bifurcation near wall max, right internal near wall max, left common near wall max, left bifurcation near wall max, and left internal near wall max). These 6 summary variables were then averaged to estimate a single mean-max near wall CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176079|NCT00065806|Secondary|Change in Mean-Mean Far Wall CIMT|For the far wall measurements for each side and segment, mean CIMT values were averaged over the 4 angles of interrogation to produce 6 summary variables (right common far wall mean, right bifurcation far wall mean, right internal far wall mean, left common far wall mean, left bifurcation far wall mean and left internal far wall mean). These 6 summary variables were then averaged to estimate a single mean-mean far wall CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176080|NCT00065806|Secondary|Change in Mean-Max Far Wall CIMT|For the far wall measurements for each side and segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 6 summary variables (right common far wall max, right bifurcation far wall max, right internal far wall max, left common far wall max, left bifurcation far wall max, and left internal far wall max). These 6 summary variables were then averaged to estimate a single mean-max far wall CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176081|NCT00065806|Secondary|Change in Mean-Mean Bifurcation CIMT|For the bifurcation arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right bifurcation near wall mean, right bifurcation far wall mean, left bifurcation near wall mean and left bifurcation far wall mean). These summary variables were then averaged to estimate a single mean-mean bifurcation CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176082|NCT00065806|Secondary|Change in Mean-Max Bifurcation CIMT|For each side and wall of the bifurcation arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right bifurcation near wall max, right bifurcation far wall max, left bifurcation near wall max and left bifurcation far wall max). These summary variables were then averaged to estimate a single mean-max bifurcation CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176083|NCT00065806|Secondary|Change in Mean-Mean Internal CIMT|For the internal carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right internal near wall mean, right internal far wall mean, left internal near wall mean and left internal far wall mean). These summary variables were then averaged to estimate a single mean-mean internal CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176085|NCT00065806|Secondary|Change in Mean-Max Common CIMT|For each side and wall of the common carotid arterial segment, the maximum CIMT over the 4 angles of interrogation was selected to produce 4 summary variables (right common near wall max, right common far wall max, left common near wall max and left common far wall max). These summary variables were then averaged to estimate a single mean-max common CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176086|NCT00065806|Secondary|Change in Mean-Mean CIMT|For each side, segment and wall, mean CIMT values were averaged over the 4 angles of interrogation to produce 12 summary variables (right common near wall mean, right common far wall mean, right bifurcation near wall mean, right bifurcation far wall mean, right internal near wall mean, right internal far wall mean, left common near wall mean, left common far wall mean, left bifurcation near wall mean, left bifurcation far wall mean, left internal near wall mean and left internal far wall mean). These 12 summary variables were then averaged to estimate a single mean-mean CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176087|NCT00065806|Secondary|Change in Mean-Max CIMT|For each side, segment and wall, the maximum CIMT over the 4 angles of interrogation was selected to produce 12 summary variables (right common near wall max, right common far wall max, right bifurcation near wall max, right bifurcation far wall max, right internal near wall max, right internal far wall max, left common near wall max, left common far wall max, left bifurcation near wall max, left bifurcation far wall max, left internal near wall max and left internal far wall max). These 12 summary variables were then averaged to estimate a single mean-max CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176088|NCT00065806|Primary|Change in Mean-Mean Common Carotid IMT (CIMT)|For the common carotid arterial segment, mean CIMT values were averaged across angles by side and wall to produce 4 summary variables (right common near wall mean, right common far wall mean, left common near wall mean and left common far wall mean). These summary variables were then averaged to estimate a single mean-mean common CIMT for each participant visit.|Change from baseline to 36 months|||mm||95% Confidence Interval|Mean
176089|NCT00065611|Secondary|CKD-EPI eGFR|Estimate glomerular filtration rate (eGFR) using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.|48 weeks from baseline|||ml/min/1.73m^2||Standard Deviation|Mean
176090|NCT00065611|Secondary|Urine Protein||48 weeks from baseline|||g/d||Standard Deviation|Mean
176091|NCT00065611|Primary|Remission Status of Patients After Intermittent Oral Dexamethasone Administered Over 48 Weeks|Complete remission is defined as proteinuria <0.3 g/d. Partial remission is defined as a 50% fall in proteinuria compared to baseline, proteinuria <3.5 g/d, and a preserved estimated glomerular filtration rate (eGFR), specified as >60% of baseline. Limited response is defined as a 50% fall in proteinuria compared to baseline. All other outcomes are described as non-response.|48 weeks from baseline|ITT||participants|||Number
176092|NCT00065507|Secondary|Number of Participants Undergoing Liver Transplant - On-Treatment or 24-Week Follow-Up||On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up.|The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.||participants|||Number
176093|NCT00065507|Secondary|Number of Participants With Malignant Neoplasms - On Treatment or During 24-Week Follow-up Period|Data includes type of malignant neoplasm.|On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date. 24-week follow-up=limited to end-of-dosing values and those from 6 days after last dose of study therapy to end of follow-up.|The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.||participants|||Number
176094|NCT00065507|Secondary|Number of Participants With Alanine Aminotransferase (ALT) Flares - On Treatment|ALT flare=ALT > 2 x baseline and > 10 x upper limit of normal (ULN) by clinical laboratory evaluation. Table includes number of participants with selected clinical events and/or laboratory abnormalities during ALT flares. Selected clinical events during ALT flares=ascites, hepatic encephalopathy, jaundice, bacterial peritonitis. Selected Laboratory abnormalities during ALT flares=international normalized ratio > 1.5 or prothrombin time >= 1.2 x ULN and total bilirubin >2.5 mg/dL and > 1 mg/dL increase from baseline.|On-treatment=up to Week 48 (Day 336); if discontinued early, all data up to 5 days after discontinuation date.|Treated participants - as treated. The on-treatment safety data set contains data from all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV. Treatment group for safety data set is based on actual treatment received.||participants|||Number
176095|NCT00065507|Secondary|Number of Participants With Treatment-Emergent Grade 3/4 Laboratory Abnormalities - Week 48 and Cumulative Data|Grade 3/4 laboratory abnormalities (hematology, electrolyte, lipase, liver function, metabolic, renal function, urinalysis). The Week 48 data set was used to evaluate the Week-48 on-treatment safety. The cumulative data set was used to evaluate the safety while on treatment. Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death.|Week 48=all on-treatment laboratory measurements up to Week 48. Cumulative data = on-treatment laboratory measurements obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|As-treated population (all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV, based on actual treatment received).||participants|||Number
176096|NCT00065507|Secondary|Cumulative Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, HCC, Discontinuations Due to AEs, and Confirmed Creatinine Increase >=0.5 mg/dL|AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event. Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Confirmed increase in serum creatinine=values ≥0.5 mg/dL compared with baseline on 2 sequential measures.|on-treatment events obtained after the start of therapy and no more than 5 days after the last dose of study therapy.|As-treated population (all randomized subjects treated with at least 1 dose of study therapy, ETV or ADV, based on actual treatment received). Note that 5 additional enrolled participants died prior to initiation of treatment and are not included in this table.||participants|||Number
176097|NCT00065507|Secondary|Number of Hepatocellular Carcinoma (HCC) Events at Different Time Points Through Week 48|HCC-free survival was analyzed using life tables. Measured values show the number of HCC events among treated participants at given time points.|Week 48|Treated, through Week 48 - (analyzed as-treated). (Week 48 on-treatment safety data contain all on-treatment data up to study Day 336, if the subject is still on treatment. If the subject discontinued before study Day 336, then all data up to 5 days after the discontinuation date were included.) n=number of participants at risk at each timepoint.||HCC events|||Number
176098|NCT00065507|Secondary|Participants Achieving Platelet Count Normalization Through Week 48|Number of participants who achieved normalization of platelet count (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.||participants|||Number
176099|NCT00065507|Secondary|Participants Achieving Total Bilirubin Normalization Through Week 48|Number of participants who achieved normalization of total bilirubin (<= 1 x ULN), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.||participants|||Number
176100|NCT00065507|Secondary|Participants Achieving Prothrombin Time Normalization Through Week 48|Number of participants who achieved normalization of prothrombin time (<= 1 x ULN), a measure of liver function, at specific timepoints.|Baseline, Week4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects - as-randomized. Excludes participants with normal prothrombin time at baseline. Non-completer = failure.||participants|||Number
176101|NCT00065507|Secondary|Participants Achieving Albumin Normalization Through Week 48|Number of participants who achieved normalization of albumin (>= 1 x lower limit of normal [LLN]), a measure of liver function, at specific timepoints.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated subjects (as randomized). Excludes subjects with normal albumin at Baseline. Non-completer = failure.||participants|||Number
176102|NCT00065507|Secondary|Change From Baseline in Platelet Count Through Week 48|Mean baseline platelet count and mean change from baseline in platelet count at specific timepoints. Platelets are the smallest particles found in the blood, which play a major role in forming blood clots. Normal range for platelets = 140 - 450 X 10*9 c/L.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.||10*9 c/L||Standard Error|Mean
176103|NCT00065507|Secondary|Mean Change From Baseline in Total Bilirubin Through Week 48|Mean total bilirubin levels, and mean change from baseline in total bilirubin, a measure of liver secretory function.Normal range for total bilirubin = 0.2 - 1.2 mg/dL.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.||mg/dL||Standard Error|Mean
176104|NCT00065507|Secondary|Mean Change From Baseline in Prothrombin Time Through Week 48|Mean prothrombin time, and mean change from baseline in prothrombin time, a measure of synthetic liver function. Prothrombin time is the time it takes (in seconds) for a sample of blood to clot. Normal range for prothrombin time (PT) = 10-13 seconds.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated, as-randomized. Subjects with normal values at baseline were excluded from the analysis. n=number of participants with value at baseline and given timepoint.||seconds||Standard Error|Mean
176105|NCT00065507|Secondary|Change From Baseline in Albumin Through Week 48|Mean albumin levels, and mean change from baseline in albumin, a measure of synthetic liver function. Normal range for albumin = 3.5 - 5.3 g/dL.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated participants - as randomized; n=number of participants with value at baseline and given timepoint.||g/dL||Standard Error|Mean
176106|NCT00065507|Secondary|Mean Changes From Baseline in Quality of Life, as Measured by EuroQol-5D (EQ-5D) at Weeks 24 and 48|The EQ-5D has 5 attributes (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression), each with 3 levels (no problem, some problems, and major problems). This algorithm gives valuation (weights) to each of the 15 responses on the form. Each valuation is a negative number, subtracted from the maximum score of 1 (perfect well being). The overall health index score ranges from 0 (dead) to 1 (perfect health) value scale, and the visual analog scale ranges from 0 to 100. Item weights will be obtained from the EuroQol group.|Baseline, Week 24, Week 48|This endpoint was not analyzed due to lack of complete data at 48 Weeks, but will be assessed at future time points.|||||
176107|NCT00065507|Secondary|Mean Changes From Baseline in Quality of Life as Measured by the Short Form 36 (SF-36)|Scoring for the SF-36 will be done using the algorithm developed by the Research ANd Development(RAND) Corporation (a scale of 0-100). Higher scores represent better quality of life. Coding for items with 2-category responses=0 and 100; 3-category=0/50/100; 5-category=0/25/50/75/100; 6-category=0/20/40/60/80/100. Scores of items in the same scale are combined to create the 8 scale scores (physical functioning, role-physical, bodily-pain, general health, vitality, social functioning, role-emotional, mental health). Physical and mental health composite scores will be computed for the group.|Baseline, Week 24, Week 48|This endpoint was not analyzed due to lack of complete data at 48 Weeks, but will be assessed at future time points.|||||
176108|NCT00065507|Secondary|Improvement or No Worsening in MELD Score Through Week 48|Participants with improvement or no worsening (any decrease or no change from baseline in score) in MELD score through Week 48. The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.||Participants|||Number
176171|NCT00064701|Secondary|Number of Participants With Clinically Treated Acute Rejection Episodes|A clinically treated acute rejection episode was any biopsy-confirmed or suspected rejection episode that was treated with immunosuppressive therapy.|one year|The number of participants analyzed represents the full analysis set.||participants|||Number
176109|NCT00065507|Secondary|Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores From Baseline Through Week 48|Adjusted mean change from baseline in MELD score through Week 48 (adjusted for baseline value). The Model for End-Stage Liver Disease (MELD), is a scoring system for assessing the severity of chronic liver disease. MELD uses the patient's values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival. In interpreting the MELD Score in hospitalized patients, the 3 month mortality is: 40 or more=100% mortality; 30-39=83% mortality; 20-29=76% mortality; 10-19=27% mortality; <10=4% mortality.|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated participants - as-randomized populations; n=number of participants with assessment at baseline and timepoint. The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are obtained after the start of therapy and <=5 days after the last dose of study therapy.||units on a scale||Standard Error|Mean
176110|NCT00065507|Secondary|Number of Participants With Improvement in Child-Pugh Class at Week 24 and Week 48|Number of Participants in each group with improvement in Child-Pugh score from baseline to Week 48 as measured by improvement in Child-Pugh class. Improvement in Child-Pugh Class is defined as change from B to A or C to A. Evaluable subjects are subjects with Child-Pugh Class B or C at Baseline. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis). Child-Pugh class A to C employs the added score from above: 5-6=Class A; 7-9=Class B; 10-15=Class C.|Week 24, Week 48|Treated participants (as-randomized). The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.||Participants|||Number
176111|NCT00065507|Secondary|Change From Baseline in Child-Pugh Score Through Week 48|Mean change from baseline in Child-Pugh score through week 48. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.||units on a scale||Standard Error|Mean
176112|NCT00065507|Secondary|Number of Participants With Improvement or No Worsening in Child-Pugh Score From Baseline to Week 48|Number of participants in each group with improvement or no worsening in Child-Pugh score from baseline to Week 48 as measured by improvement or no worsening in Child-Pugh score. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated participants (as-randomized). Non-completer=Failure. The modified intention-to-treat (ITT) efficacy data set included on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.||Participants|||Number
176113|NCT00065507|Secondary|>=2-Point Reduction From Baseline in Child-Pugh Score Through Week 48|Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).|Baseline, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48|Treated Subjects-As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after start of therapy and <=5 days after the last dose of study therapy.) Non-completer=Failure. n=number of participants with measurement at baseline and timepoint.||Participants|||Number
176114|NCT00065507|Secondary|Number of Subjects Achieving Composite Endpoint (HBV DNA < 10*4 Copies/mL by PCR Assay and Normal ALT [≤ 1.0 x ULN]) Through Week 48||Baseline, Week 4, Week 8, Week 12, Week 24, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set (includes on-treatment data collected for treated subjects. On-treatment data are those obtained after the start of therapy and no more than 5 days after the last dose of study therapy.) n=number of participants with measurement at baseline and timepoint.||Participants|||Number
176115|NCT00065507|Secondary|Number of Participants Achieving Alanine Transaminase (ALT) Normalization (≤1.0 x Upper Limit of Normal [ULN]) at Weeks 24 and 48|Number of participants in each group who achieved ALT normalization (≤1.0 x upper limit of normal [ULN]) among those with baseline ALT >1.0 x ULN at Weeks 24 and 48|Week 24, Week 48|Treated Subjects - As-Randomized population, responders only (non-completer=failure).Participants in each group who achieved ALT normalization among those with baseline ALT >1.0 x ULN.||Participants|||Number
176116|NCT00065507|Secondary|Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 48||Week 48|Treated Subjects - As-Randomized population, responders only (non-completer=failure).||Participants|||Number
176117|NCT00065507|Secondary|Number of Participants With HBV DNA < 300 Copies/mL by PCR At Week 24||Week 24|Treated Subjects - As-Randomized population, responders only (non-completer=failure).||participants|||Number
176118|NCT00065507|Secondary|Change From Baseline in HBV DNA by PCR at Week 48|Mean change from baseline in HBV DNA by PCR at Week 48, adjusted for baseline HBV DNA and LVDr Status.|Baseline, Week 48|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 48 analysis window.||log10 copies/mL||Standard Error|Mean
176119|NCT00065507|Primary|Change From Baseline in Hepatitis B Virus (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24|Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis.|Baseline, Week 24|Treated Subjects - As-Randomized, modified intention-to-treat (ITT) efficacy data set. Includes on-treatment data (obtained after the start of therapy and no more than 5 days after the last dose of study therapy) collected for treated subjects. Includes those participants with PCR measurements in the Week 24 analysis window.||log10 copies/mL||Standard Error|Mean
176505|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 8|Percentage of participants with Viral Load < 400 copies/mL|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176120|NCT00065468|Secondary|European Quality of Life Health Questionnaire (EQ-5D) - Index Score|EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.|Baseline|ITT;(N)=participants with evaluable data. Week 12 and 32 data collected for individual participants but not summarized.||units on a scale||Full Range|Median
176121|NCT00065468|Secondary|Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)|The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the “dispersion” of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.|Baseline to Month 80|ITT||months|||Number
176122|NCT00065468|Secondary|Time to Treatment Failure (TTF)|TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.|Baseline, every month until tumor progression or death (up to Month 80)|ITT||months||95% Confidence Interval|Median
176123|NCT00065468|Secondary|Duration of Response (DR)|DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.|Baseline, every month until tumor progression or death (up to Month 80)|ITT subset of participants who had a response||months||95% Confidence Interval|Median
176124|NCT00065468|Secondary|Percentage of Participants With Clinical Benefit|Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|Baseline, every 2 months until tumor progression or death (up to Month 80)|ITT||percentage of participants||95% Confidence Interval|Number
176125|NCT00065468|Secondary|Percentage of Participants With Objective Response|Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.|Baseline, every 2 months until tumor progression or death (up to Month 80)|ITT||percentage of participants||95% Confidence Interval|Number
176126|NCT00065468|Secondary|Progression-Free Survival (PFS)|PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.|Baseline, monthly until tumor progression or death (up to Month 80)|ITT||months||95% Confidence Interval|Median
176127|NCT00065468|Primary|Overall Survival (OS)|Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline up to Month 80|Intent-to-treat (ITT) Population: all randomized participants||months||95% Confidence Interval|Median
176128|NCT00065442|Secondary|Time to Objective Disease Progression|Measured by imaging studies; confirmed by independent imaging review|Analysis conducted at the time of overall survival analysis|||Weeks||95% Confidence Interval|Median
176129|NCT00065442|Primary|Overall Survival|Time from randomization until death due to any cause.|Event-driven timeframe. Final analysis at 331 events.|||Months||95% Confidence Interval|Median
176130|NCT00065429|Primary|Response Evaluation Criteria in Solid Tumors (RESIST) [Phase I and II]|Response was evaluated by RESIST and Investigator assessment at baseline and every 6 weeks. CR: all target lesions disappear with no clinical or radiographic evidence of disease progression in 2 observations. PR: At least 30% decrease in sum of the longest diameters of target lesions shown in 2 observations. SD: does not qalify for PR or PD based on 2 observations. PD: Either a) the appearance of one or more new lesions, or b) at least a 20% increase in the sum of longest diameters of target lesions|6 weeks|All patients with a baseline and follow up imaging scan were evaluated. Data represents information following the first cycle of treatment.||participants|||Number
176131|NCT00065429|Primary|Phase I Toxicity Based Upon Adverse Events Clasified by the NCI Common Terminology Ctireria Version 2.0 (Phase I)|Dose limiting toxicities graded according to common terminology criteria for advers events, version 2.0 and defined as AEs (probably/definitely related to study drug) meeting the NCI CTC criteria, assessed on the basis of the first cycle of therapy (4 weeks of weekly dosing/2 week fu): Hematologic Tox (Grade 4 neutropenia ≥ 5 days, Grade 4 thrombocytopenia, neutropenic infection); Non-Hem Toxicity: (Any grade 3 or 4 non-hematologic toxicity, excluding nausea, vomiting, diarrhea and alopecia); Toxicity present at Screening (concurrent conditions), an increase in severity of 2 or more grades.|every 6 weeks|All Phase I enrolled patients who received study drug were analyzed for DLTs.||participants|||Number
176132|NCT00065260|Secondary|Secondary Endpoints Will Include: Relapse; Clonal Evolution to Myelodysplastic Syndrome (MDS), Paroxysmal Nocturnal Hemoglobinuria (PNH) or Acute Leukemia||months/years||||||
176133|NCT00065260|Primary|No Longer Meeting Criteria for Severe Aplastic Anemia.||6 months|||participants|||Number
176134|NCT00065156|Secondary|Participants With Bone Marrow Progression|"Bone marrow aspirate was assessed by a central reviewer. Progression is represented in two categories according to changes from baseline in French-American-British (FAB) classification (see Baseline Characteristics):~Baseline classification of refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) to a during treatment (plus 30 days) classification of refractory anemia with excess blasts (RAEB).~Any baseline FAB classification to a during treatment (plus 30 days) classification of acute myeloid leukemia (AML)."|up to 2 years|Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.||participants|||Number
176135|NCT00065156|Secondary|Participants With Complete or Partial Bone Marrow Improvement|Bone marrow aspirates were assessed by a central reviewer. A complete bone marrow improvement required a baseline French-American-British (FAB) classification (see Baseline Characteristics) of refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) and a during study assessment of no MDS. A partial bone marrow improvement reflected an improved FAB classification compared to baseline (e.g. RARS to RA) but evidence of MDS continued to exist.|up to 2 years|Modified intent to treat population of participants with adequate bone marrow aspirate at baseline.||participants|||Number
176136|NCT00065156|Secondary|Participant Counts of Absolute Neutrophil Count (ANC) Response|"Major neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3 in all values obtained within 56 days of start of treatment, a ≥ 100% increase or an absolute increase of~≥ 500/mm^3, whichever was greater (at least to be ≥ 500/mm^3), sustained for 56 consecutive days. Minor neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3, an increase in ANC concentration of ≥ 100% sustained for 56 consecutive days."|up to 2 years|Evaluable participants from the modified intent to treat population. Evaluable participants are required to have a baseline absolute neutrophil count (ANC) <1 * 10^9/L.||participant|||Number
176137|NCT00065156|Secondary|Participant Counts of Platelet Response|"Major platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3 in all values within 56 days of start of treatment, an absolute increase of ≥30,000/mm^3 sustained for ≥56 consecutive days. In platelet transfusion-dependent participants, a major response was stabilization of platelet counts and platelet transfusion independence.~Minor platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3, a ≥ 50% increase in platelet count with a net increase >10,000/mm^3 for a consecutive 56-day period in the absence of platelet transfusions."|up to 2 years|Evaluable participants from the modified intent to treat population. Participants must have a baseline platelet count <100 * 10^9/L to be included in the analysis.||participants|||Number
176138|NCT00065156|Secondary|Participant Counts of Cytogenetic Response|"Participants deemed evaluable by the central cytogenetic review had their cytogenetic response categorized as major or minor. A major cytogenetic response was defined as ≥ 20 metaphases recorded at baseline, and at least~1 post baseline evaluation with ≥ 20 metaphases analyzed with no abnormal metaphases observed. A minor cytogenetic response was defined as ≥ 20 metaphases analyzed at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with a ≥ 50% reduction in the proportion of hematopoietic cells with cytogenetic abnormalities compared with baseline."|up to 2 years|Evaluable participants from the modified intent to treat population. Evaluable participants had ≥ 20 metaphases analyzed at baseline during the 56-day period immediately preceding the first day of study drug intake and ≥ 20 metaphases analyzed at least once at postbaseline visits.||participants|||Number
176139|NCT00065156|Secondary|Change in Hemoglobin Concentration From Baseline to Maximum Value During Response Period for Responders|The change from baseline in hemoglobin for participants who became RBC-transfusion independent. The maximum hemoglobin value obtained during the response period is used in the calculation of change from baseline.|Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)|Modified intent to treat population who achieved transfusion independence||g/dL||Standard Deviation|Mean
176140|NCT00065156|Secondary|Kaplan Meier Estimate for Duration of Transfusion Independence Response|Duration of response is measured from the first of the consecutive 56 days during which the participant was free of RBC transfusions to the date of the first RBC transfusion after this period. Duration of response was censored at the date of last visit for participants who maintained transfusion independence.|up to 2 years|Modified intent to treat population who achieved transfusion independence||weeks||95% Confidence Interval|Median
176141|NCT00065156|Secondary|Participants Who Relapsed or Maintained Their Transfusion Independence After Achieving Transfusion Independence During the Study|Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Participants who relapsed required a transfusion after the period of transfusion independence. Participants who maintained transfusion independence did not require a transfusion during the remainder of the study.|up to 2 years|Modified intent to treat population who achieved transfusion independence||participants|||Number
176142|NCT00065156|Secondary|Time to Transfusion Independence|Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Time to transfusion independence was defined as the day of the first dose of study drug to the first day of the first 56-day RBC transfusion-free period.|up to 2 years|Modified intent to treat population who achieved transfusion independence||weeks||Standard Deviation|Mean
176143|NCT00065156|Secondary|Participants With a >= 50% Decrease From Baseline in Red Blood Cell (RBC) Transfusion Requirements Over Any Consecutive 56 Days During Study|A participant was categorized as having a transfusion reduction response if there was a ≥ 50% decrease from pretreatment transfusion requirements (before the start of the study mediation) compared to any consecutive 56 days during the study (i.e. post treatment).|Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years)|"Modified Intent to Treat (MITT)~diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation~received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period~received ≥1 dose of study drug"||participant|||Number
176144|NCT00065156|Secondary|Participants With Adverse Experiences|"Counts of study participants who had adverse events (AEs) during the study. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator.~The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE."|Up to 2 Years|Safety population included all participants who received at least one dose of study drug.||participants|||Number
176172|NCT00064701|Secondary|Number of Participants Experiencing Multiple Rejection Episodes|This analysis includes rejection episodes that were either confirmed by biopsy by the clinical site pathologist or were clinically treated.|one year|The number of participants analyzed represents the full analysis set.||participants|||Number
176145|NCT00065156|Primary|Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence|Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive “rolling” 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin.|Up to 2 years|"Modified Intent to Treat (MITT)~diagnosis of low- or int-1-risk MDS associated with a del(5q) cytogenetic abnormality based on central hematologic and cytogenetic reviewers confirmation~received ≥2 transfusions in each of the 8-week periods during the 16 week pre-treatment period~received ≥1 dose of study drug"||participants|||Number
176146|NCT00065065|Secondary|Endoscopic Remission at 12 Weeks||12 weeks||||||
176147|NCT00065065|Secondary|Clinical Remission at 12 Weeks|Mayo Score <=2 at 12 weeks post intervention|12 weeks|||participants|||Number
176148|NCT00065065|Primary|Improvement of Signs and Symptoms of UC at 12 Weeks|Mayo score decrease >=2 points adjusted for age and smoking status.|12 weeks|||participants|||Number
176149|NCT00064844|Primary|12 Month Smoking Abstinence|Percentage of participants with prolonged carbon monoxide verified smoking abstinence|12 months after smoking quit date|||percentage of participants abstinent|||Number
176150|NCT00064844|Primary|6 Month Smoking Abstinence|Percentage of participants with prolonged carbon monoxide verified smoking abstinence|6 months after smoking quit date|||percentage of participants abstinent|||Number
176151|NCT00064792|Secondary|Cerebral Spinal Fluid Dehydrocholesterol to Total Sterol Ratio|Percent of 7-dehydrocholesterol + 8-dehydrocholesterol as a fraction of the total sterols (cholesterol + 7-dehydrocholesterol + 8-dehydrocholesterol measured in cerebral spinal fluid|12 months|||percent of total sterols||Standard Deviation|Mean
176152|NCT00064792|Primary|Serum Cholesterol to Total Sterol Ratio|Total serum cholesterol (mg/dL) divided by the sum of all sterols (cholesterol plus its precursors, 7-dehydrocholesterol - 7DHC, and 8-dehydrocholesterol- 8DHC - in mg/dL).|1 year after therapy.|The number of participants was determined by the total number of participants to complete both phases of the trial (n=18).||percent total cholesterol||Standard Deviation|Mean
176153|NCT00064753|Secondary|Renal Artery Revascularization|censored at 3 months after return to dialysis|Through July 31, 2011|||participants|||Number
176154|NCT00064753|Secondary|Abdominal Aortic Aneurysm Repair|censored at 3 months after return to dialysis|Through July 31, 2011|||participants|||Number
176155|NCT00064753|Secondary|Carotid Endarterectomy or Angioplasty|censored at 3 months after return to dialysis|Through July 31, 2011|||participants|||Number
176156|NCT00064753|Secondary|Lower Extremity PAD|censored at 3 months after return to dialysis|Through July 31, 2011|||participants|||Number
176157|NCT00064753|Secondary|Coronary Artery Revascularization|censored at 3 months after return to dialysis|Through July 31, 2011|||participants|||Number
176158|NCT00064753|Secondary|CVD Death|censored at 3 months after return to dialysis|Through July 31, 2011|P was calculated with stratified proportional hazards models stratified by country||participants|||Number
176159|NCT00064753|Secondary|RSD|censored at 3 months after return to dialysis|Through July 31, 2011|||participants|||Number
176160|NCT00064753|Secondary|Fatal/Non-fatal Stroke|censored at 3 months after return to dialysis|Through July 31, 2011|||participants|||Number
176161|NCT00064753|Secondary|Fatal/Non-fatal MI|censored at 3 months after return to dialysis|Through July 31, 2011|||participants|||Number
176162|NCT00064753|Secondary|Mortality (All-cause)|censored at 3 months after return to dialysis|Through July 31, 2011|||participants|||Number
176163|NCT00064753|Secondary|Renal Graft Failure||Through July 31, 2011|Intention-to-treat||participants|||Number
176164|NCT00064753|Primary|Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events||Through July 31, 2011 (censored 3-months post graft failure)|Censored at 3 months after return to dialysis||participants|||Number
176165|NCT00064701|Secondary|Kaplan-Meier Estimate of Graft Survival at the End of the Study|"Graft survival was defined as any participant who did not meet the definition of graft loss, where graft loss was any retransplant or the permanent return to dialysis (more than 30 days) or patient death.~Graft survival was censored at the time of last follow-up contact."|End of study (maximum time on study was 1,941 days).|The number of participants analyzed represents the full analysis set.||percentage of participants||95% Confidence Interval|Number
176166|NCT00064701|Secondary|Kaplan-Meier Estimate of Patient Survival at the End of the Study|Patient survival was defined as any participant who was alive at the end of the study. Patient survival was censored at the time of last follow-up contact.|End of study (maximum time on study was 1,941 days).|The number of participants analyzed represents the full analysis set.||percentage of participants||95% Confidence Interval|Number
176167|NCT00064701|Secondary|Change From Month 1 in Creatinine Clearance at Month 6 and Month 12|Renal function was assessed by creatinine clearance, calculated using the Cockcroft-Gault formula.|Month 1, Month 6, and Month 12|The number of participants analyzed represents the full analysis set with available data at Month 1 and at each time point.||mL/min||Standard Deviation|Mean
176168|NCT00064701|Secondary|Change From Month 1 in Serum Creatinine at Month 6 and Month 12|Renal function was assessed by the change from Month 1 in serum creatinine six months and 12 months after transplant.|Month 1, Month 6, and Month 12|The number of participants analyzed represents the full analysis set with available data at Month 1 and at each time point.||mg/dL||Standard Deviation|Mean
176169|NCT00064701|Secondary|Number of Participants Who Crossed Over Due to Treatment Failure|Participants were allowed to cross over to an alternative primary immunosuppressive regimen (either to the tacrolimus or cyclosporine treatment arms) to address an adverse event which led to randomized study drug discontinuation or in the case of severe or refractory rejection. Crossover to the modified release tacrolimus treatment arm was not permitted.|one year|The number of participants analyzed represents the full analysis set.||participants|||Number
176170|NCT00064701|Secondary|Number of Participants With Treatment Failure|Treatment failure was defined as the discontinuation of randomized study drug for any reason. Participants who met the definition of treatment failure were to be followed throughout the 12-month treatment period.|one year|The number of participants analyzed represents the full analysis set.||participants|||Number
176173|NCT00064701|Secondary|Severity of Acute Rejection|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade IA: Significant interstitial infiltration and foci of moderate tubulitis; Grade IB: Significant interstitial infiltration and foci of severe tubulitis; Grade IIA: Mild to moderate intimal arteritis in at least 1 arterial cross section Grade IIB: Severe intimal arteritis comprising >25% of the luminal area lost in at least 1 arterial cross section; Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set with a biopsy-confirmed acute rejection episode during one year.||participants|||Number
176174|NCT00064701|Secondary|Number of Participants Requiring Anti-lymphocyte Antibody Therapy for Treatment of Rejection|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Participants with histologically-proven Banff Grade II or III rejection or participants with steroid-resistant rejection were treated with anti-lymphocyte antibody treatment according to institutional practice.~Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set.||participants|||Number
176175|NCT00064701|Secondary|Time to First Biopsy-confirmed Acute Rejection Episode|"Time to first biopsy-confirmed acute rejection episode defined as the number of days from skin closure (Day 0) to the date of biopsy. Rejection episodes were confirmed by biopsy by the clinical site pathologist and graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.~Acute rejection is defined as a grade ≥ I."|one year|The number of participants analyzed represents the full analysis set.||days||Full Range|Median
176176|NCT00064701|Secondary|Percentage of Participants With Biopsy Confirmed Acute Rejection at 6 and 12 Months|"Rejection episodes were confirmed by biopsy by the clinical site pathologist. Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel.~Acute rejection is defined as a grade ≥ I."|Six months and 12 months|The number of participants analyzed represents the full analysis set.||percentage of participants|||Number
176177|NCT00064701|Secondary|Graft Survival at One Year|"Graft survival defined as any participant who did not meet the criteria for graft loss, where graft loss is defined as any re-transplant, permanent return to dialysis (> 30 days), patient death, or participant whose outcome at one year was unknown.~Participants were only counted once regardless of how many criteria were met."|One year|The number of participants analyzed represents the full analysis set.||percentage of participants|||Number
176178|NCT00064701|Secondary|Patient Survival at One Year|Patient survival is defined as any participant who is known to be alive one year after the skin closure date. Participants who died or whose outcome was unknown at one year were considered to be non-survivors.|One year|The number of participants analyzed represents the full analysis set.||percentage of participants|||Number
176179|NCT00064701|Primary|Percentage of Participants With Efficacy Failure|"Efficacy failure is defined as any participant who died, experienced a graft failure (permanent return to dialysis [> 30 days] or retransplant), had a biopsy-confirmed (Banff Grade ≥ I) acute rejection (BCAR), or was lost to follow-up.~Biopsies were graded according to the 1997 Banff criteria:~Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis Grade III: Transmural arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocytic infiltrate in vessel."|one year|The number of participants analyzed represents the full analysis set, defined as all randomized patients who received at least one dose of study drug.||percentage of participants|||Number
176180|NCT00064662|Primary|24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success)|Stress-specific success defined by composite measure including: no self-reported symptoms of stress incontinence reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire , negative results (no leakage) on a provocative stress test at standardized bladder volume and no retreatment for stress incontinence Additional treatment for SUI includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.|Two years|All participants randomized were included in time to event analysis||% stress-specific success at 24 m||95% Confidence Interval|Number
176181|NCT00064662|Primary|24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).|Success defined as composite measure including: no self-reported incontinence symptoms reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire, <15g in pad weight during 24 hr pad test, no incontinence episodes on 3-day voiding diary, negative results (no leakage) on provocative stress test at standardized bladder volume, no retreatment for urinary incontinence. Additional treatment for stress urinary incontinence (SUI) includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.|Two years|All participants randomized were included in time to event analysis.||% success at 24 months||95% Confidence Interval|Number
176182|NCT00064350|Secondary|Best Overall Response|The best overall response is the best response (per RECIST 1.0) recorded from randomization until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since randomization.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years|||Participants|||Number
176184|NCT00064350|Secondary|Progression-free Survival|Progression-free survival is defined as the duration from randomization to disease progression or death, whichever occurs first. Only randomized patients were included in this analysis.|Assessed every 8 weeks while on treatment. After the end of treatment, assessed every 3 months for 2 years, then every 6 months for 3 years.|||Months||95% Confidence Interval|Median
176185|NCT00064350|Primary|Number of Patients Maintaining Stable Disease or Objective Response 2 Months After Randomization|"Per RECIST Criteria (V1.0):~Complete Response (CR): disappearance of all target lesions Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions Progressive Disease (PD): >=20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of longest diameter recorded since randomization, or the appearance of new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD"|Two months after randomization|||participants|||Number
176186|NCT00064259|Secondary|Microarray Data|This will be primarily descriptive, and will seek to compare patterns of gene expression pre- and post-treatment.|Up to 12 weeks||||||
176187|NCT00064259|Primary|Maximum Tolerated Dose (MTD) of Oblimersen in Combination With Cisplatin and 5-FU|Adverse events were evaluated according to the National Cancer Institute Common Toxicity Criteria (version 2.0). DLT was defined as grade 3 to 4 hematologic toxicity lasting more than 1 week after 5-FU/cisplatin, grade 3 to 4 nausea or vomiting occurring later than 11 days after cisplatin, grade 3 to 4 diarrhea occurring later than 10 days after 5-FU, and grade 3 to 4 mucositis at the beginning of the next cycle.|21 days|||mg/kg/d|||Number
176188|NCT00064038|Primary|Progression-Free Survival|"Progression is defined as a > 25% increase from baseline in myeloma protein production or other signs of disease progression such as hypercalcemia, etc.~In patients with a confirmed Partial Remission, Remission, or Complete Remission, relapse is defined as the first occurrence of any of the following: 1) a myeloma protein increase by than 100% from the lowest level recorded on study, provided the absolute magnitude of this increase is at least 1g/dL for a serum monoclonal protein or at least 500 mg/24 hrs of urine M-protein; 2) a myeloma protein increase above the response criteria for Partial Remission, with the same requirements for the absolute magnitude of the protein increase; 3)reappearance of any myeloma peak that had disappeared while on protocol treatment, provided it meets the same requirements listed above; 4) increase in the size and number of lytic bone lesions recognized on radiographs."|From date of initial registration to date of progression/relapse of disease or death from any cause, whichever came first, up to 5 years|||percentage of participants||95% Confidence Interval|Number
176189|NCT00064038|Secondary|Toxicity|Compare the toxicity profile of these regimens, including thrombotic complications, in these patients, based on CTCAE v. 3.0.|From time of initiating study treatment until discontinuation of study treatment or of open-label REVLIMID + LOW DOSE DEX, whichever comes last, up to 5 years|All participants receiving at least one dose of induction therapy||Participants|||Number
176190|NCT00064025|Secondary|Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression|Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.|During the hysterectomy , which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)||Aggregate Score from Immunohistochemistr||Standard Error|Mean
176191|NCT00064025|Secondary|Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression|Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3.|During the hysterectomy, which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy)||Aggregate Score from Immunohistochemistr||Standard Error|Mean
176192|NCT00064025|Primary|Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative|"To determine the presence of a histologic response, the slide from the initial sample was compared to the slide from the matching hysterectomy specimen. A complete histologic response was defined as the absence of identifiable adenocarcinoma in the hysterectomy specimen section. A partial histologic response was subjectively defined in advance of the study based on criteria slightly modified from Wheeler et al. (Am J Surg Pathol 2007;31:988-98) as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample. A complete or partial histologic response was considered a histologic response in the analysis of data.~PR Positivity is based on aggregate score >0.2 (vs. <=0.2). Aggregate score based on product of staining intensity and area."|During the hysterectomy, which is 21-24 days after administration of depo-provera|Eligible and Evaluable Patients (patients who had both an intake biopsy and hysterectomy and had histologic response data)||percentage of participants|||Number
176193|NCT00063986|Secondary|Rate of Conversion to Open Operation After Neoadjuvant Therapy|Proportion of patients with neoadjuvant therapy required conversion to open operation is reported.|Assessed at surgery|35 eligible and treated patients with neoadjuvant therapy are included in this analysis.||Proportion of patients||95% Confidence Interval|Number
176194|NCT00063986|Secondary|30-day Peri-operative Mortality After Neoadjuvant Therapy|Proportion of patients with neoadjuvant therapy died within 30 days of operation is reported.|Assessed at 30 days after surgery|35 eligible and treated patients with neoadjuvant therapy are included in this analysis.||Proportion of patients||90% Confidence Interval|Number
176195|NCT00063986|Secondary|3-year Survival Rate|Patients are followed for survival for 3 years from registration. Overall survival is defined as the time from operation to death.|Assessed at 3 years|Eligible and treated patients are included in this analysis.||proportion of participants||95% Confidence Interval|Number
176196|NCT00063986|Secondary|Total Number of Lymph Nodes Dissected|The total number of lymph nodes dissected is reported to assess the effectiveness of lymph node dissection by MIE.|Assessed at surgery|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, the number of lymph nodes removed is missing for 1 patient, so the results are based on data from 103 patients.||Lymph nodes||Full Range|Median
176197|NCT00063986|Secondary|Overall Length of Hospital Stay|The number of days patients stayed in the hospital after surgery is reported.|Assessed after surgery until patients are out of hospital|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of hospital stay is missing for 3 patients, so the results are based on data from 101 patients.||Days||Full Range|Median
176198|NCT00063986|Secondary|Duration of Intensive Care Stay|Number of post-operative days in intensive care is reported.|Assessed after surgery until patients are out of intensive care|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, duration of intensive care stay is missing for 3 patients, so the results are based on data from 101 patients.||Days||Full Range|Median
176199|NCT00063986|Secondary|Duration of Operating Time|The length of the operation (total of thoracic and abdominal components) is recorded.|Assessed at surgery|Eligible and treated patients are included in this analysis. Out of 104 eligible and treated patients, 10 patients' length of operation data were unavailable, so the results are based on data from 94 patients.||Minutes||Full Range|Median
176200|NCT00063986|Secondary|Rate of Conversion to Open Operation|Proportion of patients who required conversion to operation will be reported.|Assessed at surgery|Eligible and treated patients are included in this analysis.||Proportion of patients||95% Confidence Interval|Number
176201|NCT00063986|Primary|Peri-operative Mortality at 30 Days|The primary endpoint is 30-day peri-operative mortality rate. Proportion of patients died within 30 days of surgery will be reported.|Assessed at 30 days from surgery|Eligible and treated patients are included in this analysis.||proportion of participants||90% Confidence Interval|Number
176202|NCT00063934|Secondary|Bcl-2 Expression in Breast Cancer Tissue|Number of participant with Bcl-2 Expression in breast cancer tissue by protein and mRNA expression before treatment and at 3-5 days after oblimersen treatment.|before treatment and at 3-5 days after oblimersen treatment|||participants|||Number
176203|NCT00063934|Secondary|Clinical Imaging Responses|Evaluation target lesions (clinical response) by physical exam/ultrasound measurements of primary tumor and axillary lymph nodes after 3-6 courses: Complete Response: Disappearance of all target lesions; Partial Response: >30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease: >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1>new lesions; Stable Disease: Neither sufficient shrinkage for PR nor increase for PD, reference smallest sum LD since treatment started.|After 3 and 6 courses of 21 day treatments (up to 18 weeks)|||participants|||Number
176204|NCT00063934|Primary|Number of Participants With Pathologic Complete Response (pCR)|Pathologic complete responses (pCR), defined as no evidence of residual invasive tumor, including no residual tumor in the axillary lymph nodes, measured by microscopic evaluation of tissue specimen at time of definitive surgery (after 6 courses of neoadjuvant therapy). Neoadjuvant (preoperative) therapy administered on the first five days of every 3-week cycle. Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]|At time of definitive surgery (after 6 courses of neoadjuvant therapy in 3 week cycles), approximately 18 weeks|Intention to treat eligible participants per protocol.||Participants|||Number
176205|NCT00063934|Primary|Participant Toxicity|Incidence of toxicity summarized using NCI Common Toxicity Criteria, version 3.0 every 3 weeks.|From baseline to study completion, every 3 weeks||||||
176206|NCT00063635|Secondary|Change in QOL- Psychosocial Health|Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.|baseline and 96 weeks|||units on a scale||95% Confidence Interval|Mean
176207|NCT00063635|Secondary|Change in Quality of Life (QOL) Scores- Physical Health|Change in self-reported QOL physical health Pediatric Quality of Life Inventory (version 4.0) scores were recorded to range from 0 to 100 with increasing scores indicating better quality of life.|baseline and 96 weeks|||units on a scale||95% Confidence Interval|Mean
176208|NCT00063635|Secondary|Change in Serum Vitamin E Levels|Change in alpha-Tocopherol|baseline and 96 weeks|||mg/L||95% Confidence Interval|Mean
176209|NCT00063635|Secondary|Change in Body Mass Index||baseline and 96 weeks|||kg/m-squared||95% Confidence Interval|Mean
176210|NCT00063635|Secondary|Number of Participants With Improvement in Ballooning Degradation Score|Ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe ballooning. This secondary outcome measure is the number of participants that experienced a decrease in ballooning score at 96 weeks compared to baseline, which indicates improvement in ballooning.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.||participants|||Number
176211|NCT00063635|Secondary|Number of Participants With Improvement in Lobular Inflammation Score|Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score at 96 weeks compared to baseline, which indicates improvement in lobular inflammation.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.||participants|||Number
176212|NCT00063635|Secondary|Number of Participants With Improvement in Steatosis Score|Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score at 96 weeks compared to baseline, which indicates improvement in steatosis.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.||participants|||Number
176213|NCT00063635|Secondary|Number of Participants With Improvement in Liver Fibrosis Score|Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score at 96 weeks compared to baseline, which indicates improvement in fibrosis.|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.||participants|||Number
176243|NCT00062751|Secondary|Area Under the Concentration-time Curve (AUC) Sum|Area under the concentration-time curve to infinity (AUC) measured as hours multiplied by nanograms divided by milliliters (hr*ng/mL) for CCI-779, sirolimus and letrozole. Sum is calculated as the sum of CCI-779 plus sirolimus AUCs (AUCsum).|Cycle 1 Day 1 (1 cycle is defined as a 14 day duration) , Cycle 3 Day 1, and Cycle 4 Day 1, Day 6, Day 9, Day 11, and Day 12|ITT; Final analysis was not conducted.||hr*ng/mL||Standard Deviation|Mean
176214|NCT00063635|Secondary|Change in Nonalcoholic Fatty Liver Disease (NAFLD) Score (Histologic Feature Scores Determined by Standardized Scoring of Liver Biopsies) From Baseline at 96 Weeks of Treatment|Histological activity was assessed using the NAFLD activity score on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (0-3), lobular inflammation (0-3), and hepatocellular ballooning (0-2).|baseline and 96 weeks|Number of participants analyzed reflects the number of participants with baseline and 96 week liver biopsies.||units on a scale||95% Confidence Interval|Mean
176215|NCT00063635|Secondary|Change in Serum Aspartate Aminotransferase (AST)||baseline and 96 weeks|||IU/L||95% Confidence Interval|Mean
176216|NCT00063635|Primary|Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L|The primary outcome was sustained reduction in ALT level, defined as 50% or less of the baseline level or 40 IU/L or less at each visit from 48 to 96 weeks of treatment.|baseline and 96 weeks|All enrolled patients were included in analysis of the primary outcome, sustained reduction in ALT level. Patients missing a 96-week ALT measurement were imputed as not achieving a sustained reduction.||participants|||Number
176217|NCT00063622|Secondary|Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis|The criteria for nonalcoholic steatohepatitis was definite or possible steatohepatitis (assessed by a pathologist) with an activity score of 5 or more, or definite steatohepatitis (confirmed by two pathologists) with an activity score of 4. This secondary outcome measure is the number of participants who met this definition at baseline and did not meet this definition after 96 weeks of treatment and thus had a resolution of steatohepatitis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks||participants|||Number
176218|NCT00063622|Secondary|Number of Participants With Improvement in Fibrosis|Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. This secondary outcome measure is the number of participants that experienced a decrease in fibrosis score, which indicates improvement in fibrosis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks||participants|||Number
176219|NCT00063622|Secondary|Number of Participants With Improvement in Hepatocellular Ballooning|Hepatocellular ballooning is assessed on a scale of 0 to 2 with higher scores indicating more severe hepatocellular ballooning. This secondary outcome measure is the number of participants that experienced a decrease in hepatocellular ballooning score, which indicates improvement in hepatocellular ballooning.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks||participants|||Number
176220|NCT00063622|Secondary|Number of Participants With Improvement in Lobular Inflammation|Lobular inflammation is assessed on a scale of 0 to 3 with higher scores indicating more severe lobular inflammation. This secondary outcome measure is the number of participants that experienced a decrease in lobular inflammation score, which indicates improvement in lobular inflammation.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks||participants|||Number
176221|NCT00063622|Secondary|Number of Participants With Improvement in Steatosis|Steatosis is assessed on a scale of 0 to 3 with higher scores indicating more severe steatosis. This secondary outcome measure is the number of participants that experienced a decrease in steatosis score, which indicates improvement in steatosis.|baseline and 96 weeks|Number of subjects with biopsy specimens at baseline and 96 weeks||participants|||Number
176222|NCT00063622|Primary|Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment.|Total nonalcoholic fatty liver disease (NAFLD) activity was assessed on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (assessed on a scale of 0 to 3), lobular inflammation (assessed on a scale of 0 to 3), and hepatocellular ballooning (assessed on a scale of 0 to 2). The primary outcome was an improvement in histological findings from baseline to 96 weeks, which required an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.|baseline and 96 weeks|All randomized participants were included in the analysis of the primary outcome.||participants|||Number
176223|NCT00063570|Secondary|Overall Survival|Overall survival time is calculated as (Date of Death as a Result of any Cause - First Dose Date + 1)/ (365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|||months||Full Range|Median
176224|NCT00063570|Secondary|Time to Treatment Failure|Time to treatment failure is calculated as (Date of First Disease Progression, Death as a Result of any Cause, or Early Discontinuation of Treatment Due to Adverse Event or Physician Perception of Lack of Efficacy or Patient and Physician Perception of Lack of Efficacy, whichever Comes First - First Dose Date + 1)/ (365.25/12)|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Intention to Treat analysis||months||Full Range|Median
176225|NCT00063570|Secondary|Time to Progressive Disease|Time to progressive disease is calculated as (Date of First Disease Progression or Death Due to Disease under Study whichever Comes First - First Dose Date + 1)/(365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Intention to Treat analysis||months||Full Range|Median
176226|NCT00063570|Secondary|Duration of (Confirmed) Complete Response or Partial Response|Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed CR or PR + 1)/(365.25/12).|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Number of patients with a confirmed complete or partial response.||months||Full Range|Median
176254|NCT00062738|Secondary|Percent Responders|Percent of patients who had a 50% decrease in total HDRS at 8 weeks|8 weeks|intent to treat||percent of patients who were responders|||Number
176227|NCT00063570|Primary|Overall Tumor Response|Best overall (confirmed) response recorded from start of treatment until disease progression/recurrence, start of other anti-tumor therapy/intervention, or end of trial, whichever comes first. Response must be confirmed at least 6 weeks from previous scans. Best overall response assignment depends on both measurement and confirmation criteria.|Every 6 weeks from start of treatment until documented disease progression or for 6 months from last dose of study drug, whichever occurs first. After 6 months, clinical assessment every 12 weeks and radiologic test performed as clinically indicated|Patients who received at least one dose of study drug (pemetrexed or gemcitabine) were included in the analyses.||participants|||Number
176228|NCT00063362|Primary|The Proportion of Patients Who Experience a Marked and Persistent Bimodal Response|"A marked bimodal response is defined by the following three conditions over four consecutive weeks while on triple therapy and after three weeks of ltg:~Montgomery Asberg Depression Rating Scale (MADRS) total score of <= 19~Young Mania Rating Scale (YMRS) total score of <= 12.5~Global Assessment Scale (GAS) score >= 51~The MADRS measures the severity of a subject's depression symptoms with a possible total score ranging from 0 - 60, with higher scores indicating more severe depression.~The YMRS measures the severity of a subject's manic symptoms with a possible total score ranging from 0 - 60, with higher scores indicating more severe mania.~The GAS measures a used to rate subjectively the social, occupational, and psychological functioning of a subject and ranges in score from 0-100, with a higher score indicating better social, occupational, and psychological functioning."|Baseline and Week 28|||participants|||Number
176229|NCT00063258|Primary|Number of Patients With Response|Response defined by tumor assessment using Response Evaluation Criteria In Solid Tumors (RECIST) to learn effectiveness of Tarceva (OSI-774) when combined with standard chemotherapy before surgery.|5 Years to collect outcome information|Analysis limited since of 5 participants enrolled, only 1 evaluable for response.||Participants|||Number
176230|NCT00063232|Secondary|Change in Insulin Sensitivity (Glucose Tolerance, Homeostatic Model Assessment of Insulin Resistence (HOMA-IR)) From Baseline|HOMA-IR is calculated from Fasting Glucose and Fasting Insulin|from baseline to 48 weeks|||unit||Standard Deviation|Mean
176231|NCT00063232|Secondary|Change in Serum Alanine Aminotransferase (ALT) Levels From Baseline (Number of Participants in Each Change Category)|Alanine transaminase <42 U/L is considered normal|from baseline to 48 weeks|||participants|||Number
176232|NCT00063232|Primary|Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category)|Patients under went liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint is a three point improvement in the histological NASH activity index with a decrease in at least two of the component scores and no worsening of fibrosis or increase in Mallory bodies.|from baseline to 48 Weeks|||participants|||Number
176233|NCT00063154|Secondary|Number of Participants Free From Disease Progression at 3, 6, and 12 Months|Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.||participants|||Number
176234|NCT00063154|Secondary|Progression-free Survival|Progression-free survival was defined as the time from the first day of pertuzumab treatment (Cycle 1, Day 1) to the time of documented disease progression (per RECIST) or death, whichever occurred first.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.||weeks||95% Confidence Interval|Median
176235|NCT00063154|Secondary|Number of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD) With HER2 Phosphorylation + or - Tumors|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.||participants|||Number
176236|NCT00063154|Primary|Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD)|A best overall response could occur at any time during the study and was determined by Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs and normalization of tumor marker level. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the treatment started for TLs and the persistence of 1 or more non-TL(s) and/or the maintenance of tumor marker level above normal limits. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started or the appearance of one or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.|Baseline to the end of the study (up to 1 year)|Efficacy-evaluable population: Participants who received at least 2 doses of pertuzumab and either underwent at least 1 post-baseline assessment of response or died as a result of disease progression before any evaluation of response.||percentage of participants|||Number
176237|NCT00062764|Secondary|Mean BMI Change||48 weeks|||kg/m2||Standard Deviation|Mean
176244|NCT00062751|Secondary|Number of Participants With Antitumor Response in Relation to Expression of Akt Phosphorylation, Cyclin D1, PTEN, and p27|Number of participants with antitumor response (CR [disappearance of all target and non-target lesions with normalization of tumor marker level] or PR [at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD]) in relation to plasma levels of Akt phosphorylation, cyclin D1, PTEN, and p27.|Prior to baseline, after Cycle 4 (Week 8), after Cycle 8 (Week 14), and cross-over or final visit (within 15 days of stopping study treatment)|ITT; Final analysis was not conducted.||participants|||Number
176245|NCT00062751|Secondary|Health Outcomes Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionaire (EORTC QLQ) BR23|Assess specificity of breast cancer symptoms relevant to participant's perceived quality of life (disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm or shoulder pain, breast pain, swollen breast, and skin problems on the breast). 23-item assessment of symptoms or problems during the past week (items 1-13 and 17-23) or during the past 4 weeks (items 14-16); range from 1 (not at all) to 4 (very much). Index scores transformed and range from 0 to 100; higher scores indicate higher level of functioning and quality of life.|Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)|ITT; Final efficacy analysis was not conducted.||scores on a scale|||Number
176246|NCT00062751|Secondary|Health Outcomes Assessment: EuroQol (EQ-5D) Health State Profile Score|EQ-5D is a self-administered questionnaire to assess health-related quality of life in 5 domains (mobility, self care, usual activities, pain or discomfort, and anxiety or depression). Scores from the 5 domains are used to calculate the Health State Profile Score as a single index value; range: 0.0 (death) to 1.0 (perfect health); higher scores indicate a better health state.|Prior to baseline, Cycle 7 (Week 12) and final visit (within 15 days of stopping study treatment)|ITT; Final efficacy analysis was not conducted.||scores on a scale|||Number
176247|NCT00062751|Secondary|Number of Participants With Survival|Number of participants with survival (alive) in the interval from start of treatment to last contact for participant or death as a result of any cause.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) until death|ITT; Final efficacy analysis was not conducted.||participants|||Number
176248|NCT00062751|Secondary|Duration of Response|Duration of response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that reoccurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. SD is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started; the minimal time interval for duration of SD is 8 weeks.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.||days||Standard Deviation|Mean
176249|NCT00062751|Secondary|Percentage of Participants Exhibiting Freedom From Progression|Freedom from progression defined as CR (disappearance of all target and non-target lesions with normalization of tumor marker level), PR (at least a 30% decrease in sum of the LD of target lesions taking as reference the screening sum LD), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD [at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions]).|Baseline, 8 weeks, 6 months, 12 months, and 24 months|ITT; Final efficacy analysis was not conducted.||percentage of participants|||Number
176250|NCT00062751|Secondary|Time to Treatment Failure|Number of days to treatment failure defined as interval from start of treatment to first date of progressive disease (at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD since the treatment started; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions) or death or discontinuation of treatment due to Adverse Event, censored at last evaluation.|Baseline until Progressive disease, death, or discontinuation of study treatment|ITT; Final efficacy analysis was not conducted.||days||Standard Deviation|Mean
176251|NCT00062751|Secondary|Time to Disease Progression|Number of days to disease progression defined as the interval from the date of randomization until the first date that recurrence or progression is documented; progression (at least 20% increase in the sum of the LD of target lesions taking as reference the smallest sum of LD; appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions).|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.||days||Standard Deviation|Mean
176252|NCT00062751|Secondary|Percentage of Participants With Best Overall Response (Clinical Benefit)|Best response (CR, PR, or stable disease (SD) lasting ≥6 months) recorded from baseline to disease progression or recurrence (Progressive disease [PD]). CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR is ≥30% decrease in sum of LD of target lesions; SD=neither sufficient shrinkage to=PR nor sufficient increase to=PD, referencing smallest sum LD since treatment started; PD is ≥20% increase in sum of LD of target lesions referencing smallest sum of LD; appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression)|ITT; Final efficacy analysis was not conducted.||percentage of participants||95% Confidence Interval|Number
176253|NCT00062751|Primary|Percentage of Participants With Objective Response (OR)|OR measured as Complete response (CR) or Partial response (PR) confirmed by assessments performed no less than 4 weeks after the criteria for the response are first met. CR=disappearance of all target and non-target lesions with normalization of tumor marker level; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, referencing the screening sum LD. Target lesions=all measurable lesions up to 5 lesions per organ (10 lesions in total), representative of all involved organs, if possible; recorded and measured at screening. Non-target lesions=all other lesions.|Baseline, every 4 cycles (1 cycle is defined as a 14 day duration) up to Cycle 25, then every 6 cycles until disease progression|Intent to treat population (ITT) defined as all participants randomized in the study. Final efficacy analysis was not conducted because the development of temsirolimus (CCI-779) for the treatment of breast cancer was terminated.||percentage of participants||95% Confidence Interval|Number
176256|NCT00062647|Primary|Clinical Response (Cure, Failure, or Indeterminate) as Determined by the Investigator Based the Presence or Absence of Clinical Signs and Symptoms Associated With Bacteremia, Metastatic Complications, or Positive Culture at the Test of Cure Evaluation|Outcomes in this exploratory study were compared for noninferiority though no specific margin was justified. The 95% CI for the difference was -35.5 to 31.9; further statistical evaluation is not warranted owing to the small sample size.|12 weeks after start of treatment|The primary efficacy analysis was of the CE Population, defined as those patients meeting meeting inclusion/exclusion criteria, meeting continuation criteria, receiving assigned study drug for at least 14 days and available for assessment of response.||participants|||Number
176257|NCT00062439|Secondary|Response|Response was defined as achieving a confirmed or unconfirmed complete or partial response as determined by RECIST. Patients who dropped out due to any cause prior to getting their response assessment were counted as non-responders. A complete response (CR) was defined as disappearance of all disease. A partial response was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was defined as confirmed if two consecutive determinations were documented at least 4 weeks apart.|After completion of induction therapy.|Eligible patients who began the treatment regimen and who had measurable disease (per RECIST) at baseline were included in the analysis of response.||percentage of participants||95% Confidence Interval|Number
176258|NCT00062439|Secondary|Progression-Free Survival at 3 Years|Duration from date of enrollment to date of progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact.|At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment.|Eligible patients who began the treatment regimen were included in the analysis.||percentage of patients||95% Confidence Interval|Number
176259|NCT00062439|Secondary|Overall Survival|The duration from the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter.|Eligible patients who began the treatment regimen were included in the analysis.||years||95% Confidence Interval|Median
176260|NCT00062439|Primary|Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel.|Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen.|After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel|Eligible patients who began the treatment regimen were included in the analysis.||percentage of participants||95% Confidence Interval|Number
176261|NCT00062439|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks.|Eligible patients who received the study intervention.||Participants|||Number
176262|NCT00062010|Secondary|Progression-free Survival|Time from registration to documented disease progression (RECIST criteria) or death.|Assessed every 6 weeks|Eligible, treated patients||months||95% Confidence Interval|Median
176263|NCT00062010|Secondary|Survival|Time from registration to death.|Assessed every 3 months for 1 year then every 6 months|Eligible, treated patients||months||95% Confidence Interval|Median
176264|NCT00062010|Primary|Response by RECIST Criteria (v 1.0)|Number of eligible, treated participants in each response category by RECIST criteria|Assessed every 6 weeks|Eligible, treated patients||participants|||Number
176265|NCT00061945|Post-Hoc|Number of Participants Achieving Complete Remission|A complete remission (CR) requires the following: an absolute neutrophil count (segs and bands) > 1500/μl, no circulating blasts, platelets > 100,000/μl; bone marrow cellularity > 20% with trilineage hematopoiesis, and < 5% marrow blast cells, none of which appear neoplastic. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement).|Duration of study (up to 10 years)|Three participants were deemed ineligible and excluded from this analysis.||participants|||Number
176266|NCT00061945|Secondary|Overall Survival (Phase II)|Will be estimated using the Kaplan-Meier method with confidence intervals presented.|3 years||||||
176267|NCT00061945|Secondary|Disease-free Survival (Phase II)|Will be estimated using the Kaplan-Meier method with confidence intervals presented.|3 years||||||
176268|NCT00061945|Secondary|Modulation of Minimal Residual Disease During Treatment With Alemtuzumab (Phase II)||Up to 10 years||||||
176269|NCT00061945|Primary|Number of Participants Who Proceed to Course V Within 2-6 Weeks of the Last Dose of Alemtuzumab (Phase II)|The primary endpoint is the number of participants who are able to proceed to course V within two - six weeks of completion of course IV.|8 months|Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis.||participants|||Number
176270|NCT00061945|Primary|Maximum Tolerated Dose (MTD) of Alemtuzumab (Phase I)|The maximum tolerated dose is defined as the highest alemtuzumab dose at which less than 40% of patients develop the dose limiting toxicity (DLT), where DLT is defined as the inability to proceed (due to medical complications) with the protocol treatment within six weeks of receiving the last dose of alemtuzumab. Groups of six patients will be enrolled into each cohort at the time of re-registration prior to starting Course IV. After a cohort has accrued 6 patients and at least 3 have completed the 2-6 week post alemtuzumab observation period without DLT, the incoming patients will be assigned to the next cohort in the table while the DLT and other toxicities continue to be assessed for the newly closed cohort. If less than 3 out of 6 enrolled patients in a cohort have completed the 2-6 week post alemtuzumab observation period without DLT, additional patients may continue to enroll in that same cohort, i.e., accrual will not be suspended while waiting for patient follow-up data.|6 weeks|Only participants who started Alemtuzumab were analyzed per study design. Specifically, one patient declined Alemtuzumab and was excluded from this analysis.||mg|||Number
176271|NCT00061932|Secondary|Change in Patterns of Gene Expression Pre- and Post-treatment Performed by GeneChip Analysis||Baseline to 6 years||||||
176506|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 4|Percentage of participants with Viral Load < 400 copies/mL|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176272|NCT00061932|Primary|True Response Rate Evaluated for the Combination of Irinotecan and PS341 by Response Evaluation Criteria in Solid Tumors (RECIST)|Tumor response was assessed every eight weeks by CT/MRI using RECIST (Response Evaluation Criteria in Solid Tumors) criteria|Up to 6 years|||participants||95% Confidence Interval|Number
176273|NCT00061893|Secondary|Event Free Survival||24 months after start of protocol therapy|By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of Event Free Survival. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.||percentage of participants||95% Confidence Interval|Number
176274|NCT00061893|Primary|Occurrence of Severe Toxicity|An incidence of severe toxicity is defined to be the occurrence of grade 3 or higher infection or grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy. If 12 or more patients experience grade 3 or higher infection or five or more patients experience grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy, the regimen will be flagged as being associated with an excessive rate of severe toxicity.|The first two cycles (6 weeks) of protocol chemotherapy|By protocol design, all eligible patients who received protocol therapy were considered in the evaluation of severe toxicity. Three (3) patients were considered ineligible. All other patients (35) started protocol therapy and are thus included in the evaluation for this measure.||participants|||Number
176275|NCT00061633|Primary|Clinical Response Which is Measured at Test of Cure (TOC) in the Clinically Evaluable (CE) Population|"Cure: Resolution of clinically significant signs, symptoms associated with the skin infection present at study admission or improvement to the extent that the infectious process had been controlled and no further therapy with study medication was necessary.~Failure: Inadequate response to study therapy or the need for significant surgical management (e.g. more than just routine debridement) of the infection site following antibiotic therapy and prior to the Test-of-Cure (TOC) visit.~Indeterminate: Inability to determine outcome."|7-14 days following end of antibiotic treatment|"The CE population were a subset of the All Treated Population and was composed of patients who met the inclusion/exclusion criteria or were granted permission to enroll and had a clinical response of cure or failure. The All Treated Population patients received at least one treatment. The Primary Efficacy Analysis was of the CE population."||participants|||Number
176276|NCT00061373|Secondary|Bleeding Events|Bleeding events of any type, severity and at any time throughout the 30-day trial period.|2 hr, 24 hr, 72 hr, 5 days, 30 days from start of study drugs|All bleeding events that occurred among all patients enrolled and throughout the 30-day trial period but not classified as a primary outcome event. Bleeding events in this category include asymptomatic ICH(aICH);major systemic bleeding after 72 hours or minor and non-significant bleeding at anytime within the 30-day period.||participants|||Number
176277|NCT00061373|Primary|Non-MRI Selected Arm: Substantial Clinical Recovery (Non-MRI Arm)|"This is the primary response outcome measure for subjects in the non-MRI arm. A positive response is measured by a 7 point or more improvement in the NIHSS or for those with less than 7 points at baseline,complete resolution of stroke symptoms.~The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have normal examination. Patients with a score of 40 have the most severe stroke symptoms."|up to 24 hours from the start of study drugs|Clinical improvement on NIHSS of 7 points or greater at 72 hours is the primary response outcome for non-MRI selected patients. Clinical response outcome was analyzed on all patients enrolled; MRI selected and non-selected patients.||participants|||Number
176278|NCT00061373|Primary|MRI Selected Arm: Complete Brain Reperfusion|This is the primary response outcome measure for patients in the MRI arm. A positive response is measured by evidence of complete reperfusion (or restoration of blood flow)on the perfusion weighted images (PWI) and mean transit time (MTT) maps of MRIs at 2 hours and sustained at 24 hours.|up to 24 hours from the start of study drugs|Complete reperfusion at 2 and 24 hours was measured in MRI-selected patients only.||participants|||Number
176279|NCT00061373|Primary|Other Serious Adverse Event Related to Study Drug Administration, Including Death.|This is a primary safety outcome for all subjects.|From start of study drugs and prior to 72-hour head CT|All Patients completed 72-hour study safety evaluation||participants|||Number
176280|NCT00061373|Primary|Major Systemic Hemorrhage|Major systemic hemorrhage is defined bleeding associated with an adjusted decrease in hemoglobin of greater than 5 grams per diluent (g/dL), or and adjusted decrease in hematocrit greater than or equal to 15 percentage points or bleeding causing persistent or significant disability or incapacity such as hemorrhage in the eye.|From the start of study drugs and prior to 72-hour head CT|All patients completed 72-hour safety evaluation||participants|||Number
176281|NCT00061373|Primary|Symptomatic Intracerebral Hemorrhage (ICH)|"This is a primary safety outcome or toxicity measure for all subjects.~Symptomatic ICH is defined as the presence of two conditions: evidence of hemorrhage on the 72-hour head CT and an increase in the NIHSS score of 4 or more points from the prior examination. Hemorrhage classifications are according to European Cooperative Acute Stroke Study (ECASS).~The NIHSS is a 15-item neurologic examination stroke scale used to evaluate the effect of acute stroke on the levels of consciousness, language, neglect, visual-field loss, extra ocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patient's ability to answer questions and perform activities. Ratings for each of the 15 items are scored. Patients who have a score of 0 are considered to have normal examination. Patients with a score of 40 have the most severe stroke symptoms."|From the start of study drugs and prior to the 72-hour safety head CT|All patients had a 72-hour safety head CT performed||participants|||Number
176282|NCT00061048|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|18 months|||participants|||Number
176283|NCT00061048|Secondary|Cell Surface Expression of CD52 on Tumor Cells|The CD52 antibody-binding capacity (ABC) value is the measurement of the mean value of the maximum capacity of each cell to bind the anti-CD52 and when determined under conditions of saturating levels of antibody measures number of mean surface CD52 antigens per cell. CD52 ABC is negative when 100% saturation by therapeutic antibody is achieved.|6 months|||ABC value||Standard Deviation|Mean
176284|NCT00061048|Primary|Time to Progression|Time between the first day of treatment to the day of disease progression which is defined as a persistent (at least two determinations) doubling of the peripheral blood leukemic cell count, the development of new lesions, or Ca elevations that are uncontrolled by conventional therapeutic procedures.|60 months|||months||95% Confidence Interval|Median
176285|NCT00061048|Primary|Overall Survival|Time between the first day of treatment to the day of death.|60 months|||months||95% Confidence Interval|Median
176286|NCT00061048|Primary|Overall Response Rate|"Overall response rate is defined as the percentage of participants with response and utilizes the International Standardized workshop definition.~Complete response(CR)-Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related symptoms if present before therapy and normalization of those biochemical abnormalities (for example LDH) definitely assignable to the lymphoma.~Please see the protocol Link module for the full criteria if desired."|60 months|||percentage of participants||95% Confidence Interval|Number
176287|NCT00060944|Secondary|Overall Survival|The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.||months||95% Confidence Interval|Median
176288|NCT00060944|Secondary|Progression-Free Survival - Independent Review|The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.||months||95% Confidence Interval|Median
176289|NCT00060944|Secondary|Duration of Response - Independent Review|Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not. Participants with confirmed response only were analyzed.||Months||95% Confidence Interval|Median
176290|NCT00060944|Secondary|Percentage of Participants Objective Response - Independent Review|Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.||Percentage of participants||95% Confidence Interval|Number
176291|NCT00060944|Primary|Time to Progression- Independent Review|Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.|From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years|All participants who were randomly assigned to one of the two schedules, independent of whether they received trabectedin or not.||months||95% Confidence Interval|Median
176292|NCT00060840|Primary|The Number of Subjects With Left Ventricular Failure During Left Ventricular Assistance Device (LVAD) Placement After Cardio Pulmonary Bypass, as Determined by Failure Criteria, After Administration of Nitric Oxide.|"Failure criteria used to measure outcome includes:~Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2~Administration of ≥ 20 inotropic equivalents (IE)~Mean arterial pressure (MAP) ≤ 55 mm Hg~Central venous pressure (CVP) ≥ 16 mm Hg~Percentage of mixed venous oxygen saturation (SvO2) of ≤ 55% OR failure to wean from cardio pulmonary bypass (CPB) at least once due to hemodynamic failure or death."|28 days|The analysis was determined for intent-to-treat population.||Participants|||Number
176293|NCT00060528|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|77.5 months|||Participants|||Number
176294|NCT00060528|Secondary|Overall Survival|Overall survival is defined as the date of on-study to the date of death from any cause or last follow-up.|50 months|||Months||Full Range|Median
176295|NCT00060528|Secondary|Number of Participants With an Objective Response|Objective response is determined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria defined as: measurable disease (at least one measurable lesion), measurable lesions (lesions that can be accurately measured in at least one dimension with longest diameter >/= 20 mm using conventional techniques or >/= 10 mm with spiral CT scan. Non-measurable lesions (all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan), i.e. bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion...|53 months|All 12 participants with measurable disease were evaluated.||Participants|||Number
176296|NCT00060528|Secondary|Percent of Participants With a Decrease (i.e. Greater Than or Equal to 30%) in PSA Levels|PSA level at the time treatment is initiated compared to the PSA level at Day 85 and monthly thereafter while the patient continues on trial)|53 months|PSA was taken at multiple time points and proportion of patients (pts) who had a decrease in PSA of at least 30% was reported. This is standard reporting procedures for tumor markers (proportion of patients with a response);similar to RECIST reporting where there may be multiple scans obtained but one reports the proportion of pts with a response||Percentage of participants|||Number
176297|NCT00060528|Primary|Number of Participants With an Immune Response|Immune response is defined as an enhanced PSA specific T-cell immune response greater than or equal to twofold post-vaccination. Peripheral blood mononuclear cells (PBMCs) were collected by apheresis prior to treatment with vaccination and after approximately three months of therapy.|48 months|||Participants|||Number
176298|NCT00060346|Primary|Objective Response to Treatment|Objective response assessed using standard myeloma response criteria. Objective response is defined as a > 50% reduction in the quantitative IgM or M-Spike levels from baseline levels. Response must be documented by two measurements separated by at least 3 weeks.|Every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, every 12 months if patient is 6-10 years from study entry|All eligible and treated patients are included in this analysis.||proportion of participants||90% Confidence Interval|Number
176299|NCT00060008|Primary|Tumor Progression as Measured by Tumor Area and Volume at 1 Year.|We correlated SUVmax and change in tumor volume over the subsequent year|One year|||percentage of change|Participants|Full Range|Median
176300|NCT00059839|Primary|Event-free Survival (EFS)|Percentage of EFS patients. This is measured as the time from study entry until disease progression, disease recurrence, occurrence of a second malignant neoplasm, or death from any cause. To measure Event Free Survival, repeated one-sided logrank tests will be performed The upper critical values are based on the one-sided alpha-spending functions of t2 (alpha=0.05) and the lower critical values are based on testing the alternative hypothesis at 0.005 level.|From first enrollment up to 3 years.|64 patients from Arm I were analyzed for this outcome measure, one patient was deemed ineligible. 61 patients from Arm II were analyzed for this outcome measure, three patients were deemed ineligible.||percentage of participants||95% Confidence Interval|Number
176301|NCT00059787|Secondary|To Determine the Tolerability of Twelve Months of Maintenance Treatment||Twelve months of maintenance|||participants|||Number
176302|NCT00059787|Secondary|To Determine Progession Free Survival With the Addition of OSI-774 (Tarceva) to the Combination of Paclitaxel and Carboplatin||The duration of the study|||months||95% Confidence Interval|Median
176303|NCT00059787|Secondary|To Measure EGFR Gene Amplification in Tumor Specimens||The duration of the study for up to 7 years|Tumor specimens were evaluated for EGFR gene amplification in 20 patients||number of tumor specimens|||Number
176304|NCT00059787|Primary|The Percentage of Participants Experiencing Toxicty (Grade 2 and Grade 3/4) Associated With the Combined Regimen|Adverse event assessment|For the duration of the study up to 7 years|Patients enrolled on all stratums included||percentage of participants|||Number
176305|NCT00059787|Primary|Pathologic Complete Response Rates|Pathologic complete response was defined as having no pathologic or cytologic evidence of disease following surgical reassessment.|Up to 7 years|Patients who had optimally debulking surgery||participants|||Number
176306|NCT00059475|Primary|Response Rate|Response is measured from the time measurement criteria are first met for complete response (CR) or partial response (PR) (whichever is first) until the first date that recurrent disease is objectively documented. Complete response is the disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.|6 years|The number of participants analyzed and results are correct. We do not have the response rate data for all patients.||participants|||Number
176307|NCT00059475|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For details about the adverse events see the adverse event module.|11 months|||Participants|||Number
176308|NCT00059475|Primary|Immunologic Response Rate|Immunologic monitoring will be conducted using in vitro sensitization assays. The immunologic response in these assays will be considered positive if at least a two-fold increase in vaccine specific interferon gamma (y-IFN) secretion is seen between post vaccination specimens compared to the pre vaccination specimens.|11 months|The number of participants analyzed and results are correct. We do not have the immunologic response rate data for all patients.||Participants|||Number
176309|NCT00059332|Secondary|Mortality||3 months|||participants|||Number
176310|NCT00059332|Secondary|Symptomatic Intracranial Hemorrhage||3 month|||participants|||Number
176311|NCT00059332|Secondary|Serious Adverse Events||3 months|||participants|||Number
176312|NCT00059332|Secondary|Stroke Impact Scale|"The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes.~Physical problems~Memory and thinking~Mood and emotions~Communication, reading and understanding~Daily activities~Mobility at home and in the community~Affected hand use~Hobbies and activities participation"|3 months|||units on a scale||Inter-Quartile Range|Median
176313|NCT00059332|Secondary|Barthel Index|"The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are:~FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)"|3 months|||units on a scale||Inter-Quartile Range|Median
176314|NCT00059332|Secondary|NIH Stroke Scale|"The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are:~1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention"|3 months|||units on a scale||Inter-Quartile Range|Median
176315|NCT00059332|Secondary|Modified Rankin Score ≤2|Functional independence based on modified Rankin score|3 months|||participants|||Number
176316|NCT00059332|Secondary|Modified Rankin Score of 0 or 1|Minimal or no disability based on the modified Rankin score|3 months|||participants|||Number
176451|NCT00055601|Secondary|Bladder-intact Survival|Bladder-intact survival was measured from the date of randomization to occurrence of cystectomy or death. Five-year rates were estimated using the Kaplan-Meier method.|From the date of randomization to the time of cystectomy, death or last follow-up. Patients are followed until death. Analysis occurs at time of primary outcome measure, approximately eight years from study start.|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
176317|NCT00059332|Primary|Modified Rankin Scale|"Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes.~0 No symptoms at all~No significant disability despite symptoms; able to carry out all usual duties and activities~Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~Moderate disability; requiring some help, but able to walk without assistance~Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~Severe disability; bedridden, incontinent and requiring constant nursing care and attention~Dead"|3 months after stroke onset|||units on a scale||Inter-Quartile Range|Median
176318|NCT00059215|Secondary|Number of Participants With Non-CABG TIMI Major or Minor Bleeding Plus MACE|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding or MACE.~Major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin.~Minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease >=3 g/dL and <= 5 g/dL.~MACE is any of the following:death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization"|randomization though 30 days after percutaneous coronary intervention (PCI)|||participants|||Number
176319|NCT00059215|Secondary|Number of Participants With Non-Coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding.~A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin."|randomization though 30 days after percutaneous coronary intervention (PCI)|||participants|||Number
176320|NCT00059215|Secondary|Number of Participants With Major Adverse Cardiovascular Events (MACE)|Number of participants with any of the following: death, nonfatal myocardial infarction, stroke, total or subtotal occlusion of the target vessel, urgent target vessel revascularization, recurrent ischemia requiring hospitalization.|randomization though 30 days after percutaneous coronary intervention (PCI)|||participants|||Number
176321|NCT00059215|Primary|Number of Participants With Non-coronary Artery Bypass Graft (Non-CABG) Thrombolysis in Myocardial Infarction (TIMI) Major or Minor Bleeding Events|"Number of participants with non-coronary artery bypass graft (non-CABG) Thrombolysis In Myocardial Infarction (TIMI) Major or Minor bleeding.~A major bleed was defined as an intracranial hemorrhage OR a clinically overt hemorrhage with a >5 g/dL decrease in hemoglobin.~A minor bleed was defined as a clinically overt hemorrhage with a hemoglobin decrease >=3 g/dL and <= 5 g/dL."|randomization though 30 days after percutaneous coronary intervention (PCI)|Patients who received at least one dose of study drug||participants|||Number
176322|NCT00058825|Secondary|Median Time to Engraftment With the Isolex/CLINIMACs System|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days|||days||Full Range|Median
176323|NCT00058825|Secondary|Number of Patients Who Engrafted With the Isolex/CLINIMACs System|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days|||participants|||Number
176324|NCT00058825|Secondary|2-year Overall Survival|Overall survival (OS) was calculated from the time of transplant to death from any cause or censored at last follow-up. Survival data were analyzed by Kaplan-Meier method.|2 years|||percentage of participants||95% Confidence Interval|Number
176325|NCT00058825|Secondary|2-year Relapse-free Survival|Relapse-free survival (RFS) was calculated from the time of transplant to the date of relapse, death, or last follow-up, whichever occurred first. Survival data were analyzed by Kaplan-Meier method.|2 years|||percentage of participants||95% Confidence Interval|Number
176326|NCT00058825|Secondary|Chronic Graft Versus Host Disease|Number of patients with Chronic Graft Versus Host Disease within 1 year post-transplant|1 year|||participants|||Number
176327|NCT00058825|Secondary|Acute Graft Versus Host Disease|Number of patients with Acute Graft Versus Host Disease within 100 days post-transplant|100 days|||participants|||Number
176328|NCT00058825|Secondary|Donor Chimerism Engraftment of Greater Than 50%|Number of patients that engrafted who showed a chimerism (donor cells) of greater than 50% in the first 30 days|30 days|Patients engrafted||participants|||Number
176329|NCT00058825|Secondary|Time in Days to ANC Engraftment|Engraftment was defined as the day of absolute neutrophil counts (ANC) exceeded 0.5 X 10^9/L on the first of 3 days.|30 days|||days||Full Range|Median
176330|NCT00058825|Primary|Transplant Related Mortality (TRM)|Percentage of patients with transplant related mortality|100 days|||percentage of participants||97.5% Confidence Interval|Number
176331|NCT00058552|Secondary|Kaplan Meier Estimate of Percentage of Participants Who Were Free of Disease Progression at 3, 6, and 12 Months|Per RECIST v 1.1, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, and/or unequivocal progression of existing non-target lesions.|3, 6, and 12 months|Efficacy Analysis Population.||percentage of participants|||Number
176332|NCT00058552|Secondary|Overall Survival|Survival was the interval of time from date of first dose of study medication to date of death at any time. Participants who had not died were censored at the date of last contact when they were known to be alive.|Days 1, 8, and 15 of Cycles 1 and 2, Day 1 of Cycles 3-17, follow-up (30 days after the last dose of pertuzumab) and then every 3 months until death or loss to follow-up (up to 5 years)|Efficacy Analysis Population. Seventeen participants in pertuzumab 420 mg arm and 33 participants in pertuzumab 1050 mg were censored for this analysis.||weeks||95% Confidence Interval|Median
176333|NCT00058552|Secondary|Percentage of Participants Who Died|The percentage of participants experiencing death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|Days 1, 8, and 15 of Cycles 1 and 2, Day 1 of Cycles 3-17, follow-up (30 days after the last dose of pertuzumab) and then every 3 months until death or loss to follow-up (up to 5 years)|Efficacy Analysis Population.||percentage of participants|||Number
176334|NCT00058552|Secondary|Duration of Response|Duration of response was defined as the time from the initial CR or PR to the time of disease progression.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Only responders (CR or PR) were included in the analysis.||weeks||95% Confidence Interval|Median
176335|NCT00058552|Secondary|Median Time of PFS|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population. Six participants in pertuzumab 420 mg treatment arm and 15 participants in pertuzumab 1050 mg treatment arm were censored for this analysis.||weeks||95% Confidence Interval|Median
176336|NCT00058552|Secondary|Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment. The percentage of participants experiencing disease progression or death was calculated as the number of participants with event divided by the number of participants analyzed, multiplied by 100.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population. Six participants in pertuzumab 420 mg treatment arm and 15 participants in pertuzumab 1050 mg treatment arm were censored for this analysis.||percentage of participants|||Number
176337|NCT00058552|Primary|Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or Cancer Antigen 125 (CA-125) Changes|Response by tumor measurement occurred if there was documented and confirmed CR or PR determined by 2 consecutive investigator assessments that were at least 28 days apart. Response was assessed by either the RECIST v 1.1 or by CA-125 changes, based on measurable or non-measurable disease at baseline. Per RECIST v 1.1 (for measurable disease), CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Per CA-125 changes (for non-measurable disease), CR: decrease in the CA-125 to within the normal limits and less than (<) 40 international units per milliliter (IU/mL) and no clinical or radiological evidence of disease, PR: a greater than (>) 50 percent (%) decrease in CA-125 values from baseline, and no clinical or radiological evidence of new lesions.|Screening and prior to infusion at Cycles 3, 5, 7, 9, 13, and 17 and at follow-up (30 days after the last dose of pertuzumab)|Efficacy Analysis Population: All participants who received at least 1 dose of study drug and either underwent at least one postbaseline assessment of response or died within 30 days after the last study treatment before any evaluation of response.||percentage of participants||95% Confidence Interval|Number
176338|NCT00058539|Secondary|Serum Concentrations of Pertuzumab||Assessed at pre-dose, 15-minutes postdose on Day 1 (Cycle 1), Day 22 (Cycle 2), Day 43 (Cycle 3), Day 85 (Cycle 5), and Day 169 (Cycle 9); pre-dose on Day 253 (Cycle 13), and on Days 8, 15, 29 and 36|Pharmacokinetic evaluable participants||micrograms per milliliter (µg/mL)||Standard Deviation|Mean
176339|NCT00058539|Secondary|Percentage of Participants Who Progressed at 3, 6 and 9 Months|Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions. Percentage of participants who were free from disease progression was calculated by subtracting the number of participants with disease progression at that time point from the total population at risk of disease progression, multiplied by 100.|3, 6, and 9 months|Efficacy analysis population||percentage of participants|||Number
176340|NCT00058539|Secondary|Duration of Response|Duration of response was defined as the time from the initial CR or PR to the time of disease progression.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|No participants experienced either CR or PR.|||||
176341|NCT00058539|Secondary|Median Time of PFS|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population. Five participants were censored for this analysis.||weeks||95% Confidence Interval|Median
176342|NCT00058539|Secondary|Percentage of Participants With Disease Progression or Death (Progression Free Survival [PFS])|PFS was defined as the time from the first day of study drug treatment to the time of documented disease progression or death, whichever came first. Participants who were lost to follow-up or who had not progressed at the time of study completion or early termination were censored at the date of last tumor assessment. The percentage of participants experiencing disease progression or death was calculated as the number of participants with an event divided by the number of participants analyzed, multiplied by 100.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population. Five participants were censored for this analysis.||percentage of participants|||Number
176343|NCT00058539|Primary|Kaplan Meier Estimate of Percentage of Participants With Disease Progression at 3 Months|Per RECIST, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of longest diameter recorded since the treatment started or the appearance of 1 or more new lesions, and/or unequivocal progression of existing non-target lesions.|3 months|Efficacy analysis population.||percentage of participants|||Number
176356|NCT00057876|Secondary|Overall Response|Response was assessed per Response Evaluation Criteria In Solid Tumors (RECIST) by CT. Overall response included complete response (CR) and partial response (PR). CR was defined as the disappearance of all target and non-target lesions. PR was defined as CR of target lesions and persistence of one or more non-target lesions or at least a 30% decrease in the sum of the longest diameters of target lesions and non-progressive disease in the non-target lesions. The 71 eligible, treated participants were included in the analysis.|assessed at week 8, and every 3 months for 2 years, then every 6 months for year 3|Eligible patients||participants|||Number
176452|NCT00055601|Secondary|Complete Response After Induction|Complete response requires the absence of any tumor in the tumor-site biopsy specimen or elsewhere and a bimanual exam that does not indicate the presence of a tumor mass.|From randomization to eight weeks|All eligible patients who started study treatment||percentage of participants||95% Confidence Interval|Number
176344|NCT00058539|Primary|Percentage of Participants With a Best Overall Confirmed Response of Complete Response (CR) or Partial Response (PR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) and Prostate Specific Antigen (PSA) Response Rate Based on Bubley Criteria|Response by tumor measurement occurred if there was documented and confirmed CR or PR. Response was assessed by both the RECIST and by PSA levels measurement, based on measurable or non-measurable disease at baseline. Per RECIST, CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A PSA response was defined as a PSA decline of greater than or equal to (≥) 50%, which had to be confirmed by a second PSA value at least 4 weeks later.|Screening, Day 1 of Cycles 1-17, and at 30 days after the last dose of pertuzumab|Efficacy analysis population: All participants who received at least 1 dose of study drug and either underwent at least 1 postbaseline assessment of response or died within 30 days after the last study treatment before any evaluation of response.||percentage of participants||95% Confidence Interval|Number
176345|NCT00058214|Secondary|Time to Progression|Estimated using the product-limit method of Kaplan and Meier. Progression was defined as the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was < 2 months.|From the date of registration to the date of documented PSA progression, assessed up to 6 years|||months||95% Confidence Interval|Median
176346|NCT00058214|Primary|PSA Response|A PSA normalization (PSA-N) - was recorded on case report forms for any evaluation in which the PSA level was undetectable (< 0.1 ng/mL). If the PSA-N response was confirmed by a second measurement ≥ 4 weeks later, the patient’s best PSA response was considered PSA-N. PSA-PR was recorded if the PSA decreased by ≥ 50% from baseline (pretreatment) values and confirmed by a second measurement ≥ 4 weeks later. PSA-PD was recorded upon the appearance of ≥ 1 new lesion on radiographs consistent with metastatic disease, an absolute increase in PSA value of 5 ng/mL relative to the lowest postenrollment PSA value (including the baseline PSA value), or if the PSA doubling time was < 2 months. PSA-SD constituted responses that did not qualify for PSA-N, PSA-PR, or PSA-PD. Response = PSA-N + PSA-PR.|Up to 6 years|||percentage of participants|||Number
176347|NCT00058019|Secondary|Time to Progression|Defined as the time from the first day of treatment until the date PD(progressive disease) or death is first reported. Patients who died without a reported prior progression was considered to have progressed on the day of their death. Patients who did not progress was censored at the day of their last tumor assessment. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|up to 3 years|||Days||95% Confidence Interval|Median
176348|NCT00058019|Secondary|Overall Survival|Defined as the time from the first day of therapy to the date of death. If the patient was lost to follow-up, survival was censored on the last date the patient was known to be alive.|up to 3 years|||Days||95% Confidence Interval|Median
176349|NCT00058019|Secondary|Duration of Response|Duration of response was measured from the time measurement criteria are met for CR(complete response)/CRu(unconfirmed complete response)/PR(partial response), whichever was first recorded, until the first date that PD(progressive disease) was objectively documented. According to the 1999 international response criteria as published by Cheson, CR/CRu is defined as the disappearance of all target lesions; PR is defined as >=50% decrease in the sum of the products of the greatest diameters; PD is defined as >=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.|up to 3 years|||Days||95% Confidence Interval|Median
176350|NCT00058019|Primary|Safety and Toxicity of Ixabepilone|Number of patients experiencing adverse event grade 3 or above. Grade was determined by the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0. Adverse events possibly, probably, or definitely attributed to use of ixabepilone.|up to 3 years|||participants|||Number
176351|NCT00058019|Primary|Objective Overall Response Rate|The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10561185) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires >=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.|up to 3 years|||participants|||Number
176352|NCT00057954|Secondary|Progression-free Survival|Progression-free survival was defined as time from enrollment to disease progression or death from any cause, whichever occurred first. Patients who did not have progression-free survival events were censored at last date of disease assessment.|Assessed day 100 post transplant and every 3 months during year 1, every 6 months during years 2-3, then every 12 months during years 4-5 or through diagnosis of disease progression|all 6 enrolled patients||days||95% Confidence Interval|Median
176353|NCT00057954|Secondary|100-day Overall Survival|Proportion of patients who survived 100 days or more after enrolled on the study|Assessed at least twice a week for the first 60 days and weekly until day 100.|all 6 enrolled patients||Proportion of participants||95% Confidence Interval|Number
176354|NCT00057954|Primary|Proportion of Participants With Successful Engraftment||Assessed daily during inpatient stay|all enrolled 6 patients||Proportion of participants||95% Confidence Interval|Number
176355|NCT00057941|Primary|Clinical Benefit Rate|Clinical benefit = complete response (CR), partial response (PR), or stable disease (SD) lasting for at least 6 months, assessed per Response Evaluation Criteria of Solid Tumor (RECIST).CR=disappearance of all target and non-target lesions. PR= disappearance of or at least 30% decrease in the sum of the longest diameters of target lesions, with non-progressive disease in non-target lesions. SD= sum of the longest diameters of target lesions decrease <30% or increase <20%, with non-progressive disease in non-target lesions. 141 eligible, treated patients were included.|assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years|141 eligible and treated patients, 72 on Arm I (Anastrozole and ZD1839) and 69 on Arm II (Fulvestrant and ZD1839)||percentage of participants||95% Confidence Interval|Number
176475|NCT00054847|Secondary|Myocardial Infarction||Within 1 year of bypass surgery|||participants|||Number
176476|NCT00054847|Secondary|Death||Within 1 year of surgery.|||participants|||Number
176357|NCT00057876|Secondary|Progression-free Survival Time|Time from randomization (registration) to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions (taking as reference the baseline sum longest diameter), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients who received treatment beyond 3 years were also followed for survival.|assessed every 3 months for 2 years, then every 6 months for year 3|67 eligible patients with data on progression-free survival(PFS)||Months||95% Confidence Interval|Median
176358|NCT00057876|Primary|Overall Survival Time|Overall survival was defined as the time from randomization (registration) to death from any cause. Patients alive at last follow-up were censored. Patients were followed every 3 months for 2 years and then every 6 months for year 3. Patients received treatment beyond 3 years were also followed for survival.|assessed every 3 months for 2 years, then every 6 months for year 3|71 eligible patients||Months||95% Confidence Interval|Median
176359|NCT00057863|Secondary|Toxicities, Assessed and Graded According to CTCAE Version 3.0|Exact 95% confidence intervals will be calculated. The 95% confidence interval was not calculated for the toxicities|Up to 7 years|There were 135 cycles administered.||percentage of grade 3/4|||Number
176360|NCT00057863|Secondary|Overall Survival|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|From first treatment day until death, assessed up to 7 years|||weeks||95% Confidence Interval|Mean
176361|NCT00057863|Secondary|Progression-free Survival|Assessed by Kaplan-Meier survival analysis and 95% confidence intervals will be calculated using Greenwood's formulae.|From first treatment day until objective or symptomatic progression or death, assessed up to 7 years|||weeks||95% Confidence Interval|Mean
176362|NCT00057863|Primary|Overall Objective Response Rate (CR+PR)|95% confidence interval will be estimated via binomial proportions.|Up to 7 years|||participants|||Number
176363|NCT00057837|Secondary|Overall Survival|Overall survival is defined as the time from randomization to death.|Assessed every 3 months for 2 years, then every 6 months for 1 years|Only eligible and treated patients are included in this analysis.||Months||95% Confidence Interval|Median
176364|NCT00057837|Secondary|Duration of Response|Duration of response is defined as the period measured from the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease is objectively documented, taking as reference the smallest measurements recorded since treatment started.|Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.|Only eligible and treated patients with response are included in this analysis.||Months||95% Confidence Interval|Median
176365|NCT00057837|Primary|Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)|"Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.~Objective response = CR + PR"|Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.|Only treated and eligible patients are included in this analysis.||proportion of participants||90% Confidence Interval|Number
176366|NCT00057811|Primary|Toxic Death|Implementation of the toxic death rate stopping rule, a death must be possibly, probably or definitely attributable to Rituximab and/or chemotherapy to be considered a toxic death.|Up to 1 year|Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.||participants|||Number
176367|NCT00057811|Primary|Minimal Residual Disease|The presence or absence of tumor cells at the end of induction assessed by studying tissue and/or blood/marrow. Details of methods and criteria used can be found in Shiramizu at al. BJH 153:758-763, 2011 (full citation in the citation section).|Not Provided|Population analyzed included patients submitting samples for minimal disease assay at end induction||percentage of samples analyzed||95% Confidence Interval|Number
176368|NCT00057811|Primary|Response Rate|Response includes both complete and partial responses. Per protocol, complete Response is defined as the complete disappearance of all clinical evidence of disease by physical examination, by imaging studies, by bone marrow biopsy (where indicated), by CNS evaluation (where indicated) and by biopsy where there is a residual abnormality on an imaging study. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present. Partial response is defined as: at least a 50% reduction in the size of all measurable tumor areas. Each site is to be defined by the product of the maximum length, width and depth (3 dimensions). No lesion may progress. No new lesion may appear. Bone marrow must contain <5% blasts. CSF WBC must be <5/μL with no blasts or lymphomatous cells present..|Up to 5 years|Population analyzed includes eligible patients considered evaluable for response (with measurable disease at on study and adequate assessment of response).||percentage of participants analyzed||95% Confidence Interval|Number
176369|NCT00057811|Primary|Grade ≥ 3 Stomatitis|The incidence of grade ≥ 3 stomatitis. Grade 3 stomatitis: Confluent ulcerations or pseudomembranes; bleeding with minor trauma. Grade 4 stomatitis: Tissue necrosis; Significant spontaneous bleeding; life-threatening consequences|Up to 1 year|Population analyzed includes eligible patients (Group B:46; Group C: 42). Three additional patients (Group B:1; Group C:2) have been excluded as inevaluable per the study chair.||participants|||Number
176370|NCT00057785|Secondary|Chemotherapy Compliance||From start of treatment to end of treatment||||||
176371|NCT00057785|Secondary|Other Acute and Late Toxicities||From start of treatment to last follow-up||||||
176372|NCT00057785|Secondary|Whole Mouth Saliva Output Relative to Pretreatment Measurements||From start of treatment to 1 year||||||
176373|NCT00057785|Secondary|Rate of Locoregional Control at 2 Years||From registration to 2 years||||||
176374|NCT00057785|Secondary|Rate of Xerostomia at 1 Year (Grade ≥ 2)||From start of treatment to 1 year||||||
176499|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 56|Percentage of participants with Viral Load < 400 copies/mL|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176375|NCT00057785|Primary|Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered|Patients scored by the study chairs as no variation or minor variation were considered compliant, while patients scored as major variation or inevaluable were considered non-compliant. The number being reported is the number non-compliant. A compliance rate of 90% was targeted with 75% or lower being considered unacceptable. Fifty-seven patients were required with types I and II error rates both 0.10. If 10 or more patients out of 57 were non-compliant, the treatment would be unacceptable, per a two-stage Fleming multiple testing procedure.|From start of treatment to end of treatment|First 57 eligible patients who started study treatment.||participants|||Number
176376|NCT00057746|Primary|Incidence of Chronic Neurotoxicity|Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.|From study registration to one year.|||percentage of participants||95% Confidence Interval|Number
176377|NCT00057681|Secondary|K-SADS Mania Rating Scale|The K-SADS Mania Rating Scale (KMRS) is comprised of 15 items modified from WASH-U-KSADS items. The individual items are scored on a 1-6 severity scale and then these item scores are summed to create an overall KMRS score. Guidelines for interpretation are as follows: 0-11 = no or minimal mania, 12-17 = mild mania, 18-25 = moderate mania, 26+ = marked or worse mania. The maximum possible score is 64.|Measured at Week 8|KMRS data were analyzed for all subjects completing 8 weeks of the study.||units on a scale||Standard Deviation|Mean
176378|NCT00057681|Secondary|Modified Side Effects Form for Children and Adolescents|The Modified Side Effects Form for Children and Adolescents includes 62 potential side effects, with measures of frequency and severity for each item. Frequencies are 0=not present, 1=1-2 days, 2=3-4 days, 3=5-7 days. Severity scores are 0=not present, 1=mild (does not interfere with functioning), 2=moderate (some interference with functioning), 3=severe (functioning is significantly impaired because of side effects). Items for cardiovascular, gastrointestinal, central nervous system, ocular, mouth and nose, genito urinary, dermatology, musculo-skeletal, and other side effects are included. For analyses, side effects that were reported at any frequency and a severity of 2 or greater were considered present.|Measured at Week 8|Modified Side Effects Form for Children and Adolescents data were analyzed for all subjects completing 8 weeks of the study.||side effects at week 8||Standard Deviation|Mean
176379|NCT00057681|Primary|Clinical Global Impressions-Bipolar Mania Improvement|The Clinical Global Impressions-Bipolar (CGI-BP) assessment instrument measured improvement in mania, depression, and overall bipolar illness. The primary outcome measure was mania improvement, which measured the change in mania from baseline. Scores were 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.|Measured at Week 8|CGI-BP mania improvement data were analyzed for all subjects completing 8 weeks of the study.||units on a scale||Standard Deviation|Mean
176380|NCT00057577|Other Pre-specified|Serious Adverse Events|Serious Adverse Events (SAEs) as reported to the Institutional Review Boards and Data Safety Monitoring Board throughout the duration of the study|Thorought study||06/2016||||
176381|NCT00057577|Primary|Number of Participants in Recurrence According to the LIFE and HRSD|Recurrence defined as two consecutive weeks of elevated LIFE PSR scores of 5 or above and HRSD scores of 16 or above (three weeks during period of medication withdrawal)|Measured up to Month 36 from recovery||06/2016||||
176382|NCT00057577|Primary|Number of Participants in Recovery According to the LIFE and HRSD|Six consecutive months following remission without relapse (two weeks of elevated LIFE PSR scores of 4 or more and HRSD scores of 14 and above)|Through 36 months of treatment|||number participants that reach recovery|||Number
176383|NCT00057577|Primary|Number of Participants in Remission According to the Longitudinal Interval Follow-up Evaluation (LIFE) and the Hamilton Rating Scale for Depression (HRSD)|Remission defined as four consecutive weeks of LIFE Problem Symptom Rating (PSR) values of 2 or less and HRSD scores of 8 or less for four consecutive weeks (with partial remission defined as LIFE PSR values of 3 or less and HRSD scores of 12 or less after month 12 only)|Through month 18 of treatment|||number participants that reach remission|||Number
176384|NCT00057551|Primary|Remission|Hamilton Depression Scale (HAM-D)<8 and does not meet DSM-IV criteria for Major Depressive Disorder for 2 consecutive visits|12 weeks|||percentage of participants|||Number
176385|NCT00057330|Secondary|Number of Subjects Reporting Serious Adverse Events (SAEs)|SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in a subject’s offspring.|Throughout the study (From Month 0 up to Month 20)|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
176386|NCT00057330|Secondary|Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)|NOCDs included adverse events (AEs) as autoimmune disorders, asthma, type I diabetes, allergies. MSCs included AEs prompting emergency room or physician visits unrelated to common diseases or routine visits for physical examination or vaccination, or SAEs unrelated to common diseases. SAEs included medical occurrences either life-threatening, requiring hospitalization, or resulting in death, disability/incapacity or congenital anomaly/birth defect in a subject’s offspring. Common diseases included upper respiratory infections (URIs), sinusitis, pharyngitis, gastroenteritis, urinary tract infection, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. The following were not reported if not considered as SAEs and occurring more than 30 days post vaccination: URIs, sinusitis, pharyngitis, gastroenteritis, injury, or visits for routine physical examination or vaccination. AEs are described, using Medical Dictionary for Regulatory Activities’ preferred terms.|Throughout the study (From Month 0 up to Month 20)|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
176411|NCT00056407|Secondary|Mean Change From Baseline in Testosterone at Month 48|Testosterone, a male sex hormone, was measured by taking blood samples at screening and yearly thereafter.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.||percent change||Standard Deviation|Mean
176387|NCT00057330|Secondary|Number of Subjects Reporting Unsolicited Adverse Events (AEs)|Unsolicited AEs have been tabulated for a 31-day period. An unsolicited AE was any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.|Within 31 days after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
176388|NCT00057330|Secondary|Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms|"Solicited general symptoms assessed were fatigue, headache, malaise and fever (oral/axillary/tympanic).~Grade 3 headache, fatigue, malaise = symptom that prevented normal activities.~Grade 3 fever = temperature above 39.0 degrees Celsius.~Related = symptom assessed by the investigator as causally related to the vaccination"|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
176389|NCT00057330|Secondary|Number of Subjects Reporting Grade 3 Solicited Local Symptoms|"Solicited local symptoms assessed were pain, redness and swelling.~Grade 3 pain = pain that prevented normal activities.~Grade 3 redness/swelling = redness/swelling above 30 mm and persisting for more than 24 hours"|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
176390|NCT00057330|Secondary|Number of Subjects Reporting Solicited Local and General Symptoms|"Solicited local symptoms assessed were pain, redness and swelling.~Solicited general symptoms assessed were fatigue, headache, malaise and fever (defined as oral/axillary/tympanic temperature equal to or above 37.5 degrees Celsius)."|Within 7 days (Days 0-6) after vaccination|The Intention To Treat cohort for the analysis of safety included all vaccinated subject for whom safety data were available.||Subjects|||Number
176391|NCT00057330|Secondary|Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.|Titers for Anti-HSV neutralizing antibodies are presented as Geometric Mean Titers (GMTs), and are expressed in Estimated Doses (ED), that is, the reciprocal of the dilution necessary to achieve neutralization. Antibody titers below the lowest level of quantification were not calculated .|At Months 0, 2, 6, 7, 12, 16 and 20|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (meeting eligibility criteria, complying with protocol-defined procedures and not meeting either the infection or disease criteria on or prior to Month 7) for whom data concerning immunogenicity outcome measures were available.||ED||95% Confidence Interval|Geometric Mean
176392|NCT00057330|Secondary|Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.|Antibodies were measured by Enzyme-linked immunosorbent assay (ELISA). Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EU/mL). The seroprotection cut-off of the assay was 40 EU/mL|At Months 0, 2, 6, 7, 12, 16 and 20|The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (meeting eligibility criteria, complying with protocol-defined procedures and not meeting either the infection or disease criteria on or prior to Month 7) for whom data concerning immunogenicity outcome measures were available.||EU/mL||95% Confidence Interval|Geometric Mean
176393|NCT00057330|Secondary|Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion|The number of subjects with newly acquired HSV-2 infection confirmed by either virus culture or HSV-2 seroconversion was tabulated. Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 7 and 20|The Per Protocol cohort for analysis of efficacy (Months 7-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 3 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.||Subjects|||Number
176394|NCT00057330|Secondary|Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion.|The number of subjects with newly acquired HSV-2 infection confirmed by either virus culture or HSV-2 seroconversion was tabulated. Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 2 and 20|The Per Protocol cohort for analysis of efficacy (Months 2-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 2 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.||Subjects|||Number
176395|NCT00057330|Secondary|Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2|Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 7 and 20|The Per Protocol cohort for analysis of efficacy (Months 7-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 3 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.||Subjects|||Number
176412|NCT00056407|Secondary|Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48|Number of participants whose DHT, the active form of the male sex hormone testosterone, was less than 0.555 nanomoles/liter and below the level of detection at Month 48 was measured. It was measured by taking blood samples at screening and yearly thereafter.|Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.||participants|||Number
176500|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 48|Percentage of participants with Viral Load < 400 copies/mL|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176396|NCT00057330|Primary|Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2|Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.|Between Months 2 and 20|The Per Protocol cohort for analysis of efficacy (Months 2-20) included all subjects who met inclusion/exclusion criteria, did not meet infection/disease, did not meet censoring criteria, had at least 1 efficacy assessment, received 2 doses of the vaccine within the permitted time interval, with known vaccine administration site and route.||Subjects|||Number
176397|NCT00056862|Secondary|Time to Negativity|Time from treatment initiation to the first negative HCV RNA test during treatment|24 weeks|||days||95% Confidence Interval|Median
176398|NCT00056862|Secondary|Slope of Second Phase Decline in HCV Levels|The 2nd phase slope is defined as the slope of the logarithmic viral levels from week 1 to week 4 of treatment (see Neumann et al, Science, 1998).|day 7 to day 28|||logIU/mL||Standard Deviation|Mean
176399|NCT00056862|Primary|Virological Response Category (Per Protocol)|Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped.|6 months after therapy|Per protocol||participants|||Number
176400|NCT00056862|Secondary|First Phase Decline in Logarithm of HCV RNA Level|The 1st phase decline is defined as the log difference between baseline HCV RNA level and the level on day 2 of treatment (see Neumann et al, Science, 1998).|2 days|||logIU/mL||Standard Deviation|Mean
176401|NCT00056862|Primary|Virological Response (Intention to Treat)|Virological response category. Sustained virological response (SVR) is defined as negative serum HCV RNA at least 6 months after the end of treatment. Non-response is defined as serum HCV RNA positivity on week 12 of treatment. Breakthrough/relapse is defined as HCV RNA becoming negative and subsequently positive on treatment or after treatment is stopped.|6 months after stopping therapy|Intention-to-treat||participants|||Number
176402|NCT00056563|Secondary|The Change of Scores on the UPDRS for Blinded Assessed Motor Function 'Off' Medication and 'on' Stimulation|Unified Parkinson’s Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery. UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses. The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit. The higher score indicates that the condition is worse.|at six months|||units||95% Confidence Interval|Mean
176403|NCT00056563|Primary|The Difference of Time Spent in the 'on' State Without Troublesome Dyskinesia Based on Patient Motor Diaries as Compared to the Baseline.||at six months|||Hours per day||95% Confidence Interval|Mean
176404|NCT00056550|Secondary|Local Assessment of Thromboembolism by Physical Examination.|The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.|30 days after last dose|14 patients were included in the trial and treated with rhAT.||Participants in study|||Number
176405|NCT00056550|Primary|Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).|Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).|Baseline, last day of dosing and day 7 (+ or - 1 day)|14 patients who received at least 1 dose of rhAT were included in the Safety population. During the central review of the duplex ultrasound, 1 delivery patient was diagnosed with a DVT at baseline, and was not evaluable for efficacy, the patient was excluded from the PP population.||participants|||Number
176406|NCT00056498|Secondary|Neuropsychological Testing||Measured at baseline and Week 16||08/2015||||
176407|NCT00056498|Primary|Brief Psychiatric Rating Scale (BPRS)|Scale assesses psychotic symptoms on a 20-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe.|Measured at baseline and every 2 weeks for 16 weeks|64 participants began study medication and were used in the Intent to Treat(ITT) analyses (risperidone: 30; placebo:34). 53 subjects were used in the completer analyses (risperidone: 25; placebo: 28) BPRS items 4, 11, 12, and 15 (positive symptoms of schizophrenia), potentially ranging from 4 to 28 were used in the analyses.||Units on Scale||Standard Deviation|Mean
176408|NCT00056472|Other Pre-specified|Mean Score Hamilton Depression Rating Scale (Ham-D) Over the Course of the Trial From Week to Week.|The Ham-D measures depression severity. Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression.|Weeks 1 to 12|||Scores on Ham-D||Standard Error|Mean
176409|NCT00056472|Secondary|Scores on CGI-S Compared to Baseline Over the Course of the Trial|A measure of overall symptom severity, the Clinical Global Impressions, Severity of Illness Scale (CGI-S). It is a seven point scale with a one indicating not at all ill, and seven indicating the most extremely ill. This rating was done each week after baseline by the PI at each site after visiting with the patient.|Weeks 1 to 12|||units on CGI scale||Standard Error|Mean
176410|NCT00056472|Primary|Remission of Depression Hamilton Depression Scale (Ham-D) and Psychosis Schedule for Affective Disorders in Schizophrenia - Delusional Item (SADS) During the Course of the Trial|"Remission was defined as scores on Ham-D of less than 10 at two consecutive assessments and the absence of delusions (measured as SADS delusional item scores of 1) at the second assessment of the two-assessment remission of depression interval.~Scores on Ham-D range from 0 to 52 with higher scores indicating more severe depression. Scores on SADS range from 1 to 7 with higher scores indicating the delusions(s) more adversely effect the subject's behavior."|Weeks 1 to 12|||participants|||Number
176450|NCT00055692|Primary|Progression-free Survival||At 6 months|||percentage of participants||95% Confidence Interval|Number
176413|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48|The PASSFI is a 3-item questionnaire that measures sexual function. Responses range from 0 (big problem) to 4 (no problem), with a total score of 12. A higher score indicates fewer problems with sexual functioning. Participants completed the questionnaire at Baseline and then yearly . Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.||points on a scale||Standard Error|Mean
176414|NCT00056407|Secondary|Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48|The QOL Q8 is the last question of the IPSS Questionnaire. It is a question about the participant's quality of life as it relates to prostate symptoms. Responses range from 0 (most positive) to 6 (most negative). A higher score indicates worse quality of life. Participants completed the questionnaire at Screening, Baseline, and at each 6-month visit. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.||points on a scale||Standard Error|Mean
176415|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48|The NIH CSPI is a 9-item questionnaire that measures chronic prostatitis symptoms. The total score ranges from 0 to 43. A higher score indicates greater negative impact of prostatitis. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from Baseline = Baseline Value and Cluster and Treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.||points on a scale||Standard Error|Mean
176416|NCT00056407|Secondary|Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48|The MOS Sleep-6S is a 6-item questionnaire measuring quality of sleep. Scores range from 1 (all of the time) to 6 (none of the time) and are converted to a 1-100 scale and then averaged; a higher score indicates greater negative impact, which indicates more sleep disturbance. Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model: change from baseline=baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.||points on a scale||Standard Error|Mean
176417|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48|The BII is a 4-item questionnaire that rates the level of BPH-related physical discomfort, worry, and interference with normal activities the participant has experienced. The total BII score ranges from 1 (no impact on symptoms) to 13 (major impact on symptoms). Participants completed the questionnaire at Baseline and at each 6-month visit. Participants whose language did not have a validated translation of the questionnaire did not participate. Estimates are based on the adjusted means from the general linear model:change from baseline = baseline value and cluster and treatment.|Baseline and Month 48|Efficacy Population (LOCF). The numbers presented are less than the overall population, as data were not available for all participants.||points on a scale||Standard Error|Mean
176418|NCT00056407|Secondary|Overall Survival|Overall survival is assessed as the number of deaths reported throughout the study.|From time informed consent is signed to 4-month Safety Follow-Up period|Efficacy Population||number of deaths|||Number
176419|NCT00056407|Secondary|Number of Participants With Post-biopsy Macroscopic Hematospermia|Participants reported events of macroscopic hematospermia (visible blood in semen) throughout the study.|Baseline through Year 4|Efficacy Population||participants|||Number
176420|NCT00056407|Secondary|Number of Participants With Post-biopsy Macroscopic Hematuria|Participants reported events of macroscopic hematuria (visible blood in the urine) throughout the study.|Baseline to Year 4|Efficacy Population||participants|||Number
176421|NCT00056407|Secondary|Number of Participants With at Least One Urinary Tract Infection (UTI)|A participant was considered to have a UTI if the investigator noted that the participant had UTI symptoms and had been prescribed antibiotics. Participants were asked to report any events of UTI during the study.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population||participants|||Number
176422|NCT00056407|Secondary|Number of Participants With at Least One Event of Acute Urinary Retention (AUR)|A participant was considered to have AUR when he reported being unable to urinate and required catherization. Participants were asked to report any events of AUR during the study.|Years 1-2 and Overall (Years 1-4)|Efficacy Population||participants|||Number
176423|NCT00056407|Secondary|Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms|Medication taken during the study, including alpha blockers, was recorded at each 6-month study visit and during phone calls that occurred 3 months after each visit.|Years 1-2, Overall (Years 1-4)|Efficacy Population||participants|||Number
176424|NCT00056407|Secondary|Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48|Maximum urinary flow was measured at selected sites using a Dantec Uroflow meter with a Thompson filter. Change from baseline was calculated as Month 12, 24, 36, and 48 values minus the baseline value. Estimates are based on the adjusted means from the general linear model: change from baseline = baseline Qmax and treatment. This measurement was performed at selected centers.|Baseline and Months 12, 24, 36, and 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.||milliliters/second||Standard Error|Mean
176425|NCT00056407|Secondary|Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48|Prostate volume was measured by transrectal ultrasound (TRUS) when biopsies were performed at Year 2 and Year 4. The investigator calculated the prostate volume using three prostate measurements (anteroposterior, cephalocaudal, and transverse diameters). Estimates are based on the adjusted means from the general linear model: log(Post-Baseline/Baseline value) = treatment and cluster and log (baseline value).|Baseline, Month 24, and Month 48|Efficacy Population (LOCF). The number analyzed is smaller than the total number in the population due to missing values.||percent change||Standard Error|Mean
176426|NCT00056407|Secondary|Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48|The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted means from the general linear model: change from baseline = baseline value and cluster and treatment.|Baseline to Year 4 (Month 48)|Efficacy Population, last observation carried forward (LOCF). In the LOCF approach, missing values at post-baseline assessments are replaced with the participant's previous non-missing post-baseline assessment. The number analyzed is smaller than the total number in the population due to missing values.||points on a scale||Standard Error|Mean
176427|NCT00056407|Secondary|Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment|The number of participants who received treatment for prostate cancer was measured. Prostate cancer interventions included surgical interventions (e.g., prostatectomy, adenomectomy, transurethral resection) and non-surgical interventions (e.g., chemotherapy, hormone therapy, radiation therapy).|Baseline to Year 4|Efficacy Population||participants|||Number
176428|NCT00056407|Secondary|Treatment Alteration Score|The treatment alteration score is a measure of the cellular changes due to treatment (effect of male hormone withdrawal) on the nucleus and cytoplasm of the prostate cancer cell. The treatment alteration score is the sum of two scores (the nuclear alteration score and the cytoplasmic architectural score), each ranging from 0 to 3, with 0 indicating no change and 3 indicating severe changes.|Baseline to Year 4|Biopsied Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.||points on a scale||Standard Deviation|Mean
176429|NCT00056407|Secondary|Number of Cancer-positive Cores|The average number of prostate biopsy samples (cores) determined to be cancerous by the pathologist was measured. Normally, 10 cores were taken per biopsy for each participant.|Baseline to Year 4|Prostate Cancer Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.||number of cores||Standard Deviation|Mean
176430|NCT00056407|Secondary|Percentage of Core Involved at Diagnosis|The average amount of cancer seen by the pathologist in the prostate tissue samples taken during the biopsy was measured. A core is a prostate biopsy sample.|Baseline to Year 4|Prostate Cancer Population: all participants in the Efficacy Population who received a post-baseline diagnosis of prostate cancer by the central pathology laboratory. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.||percentage of core||Standard Deviation|Mean
176431|NCT00056407|Secondary|Volume of HGPIN at Biopsy|The amount of prostate biopsy tissue with HGPIN was measured.|Baseline to Year 4|Biopsied Population. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.||cc*10^-3 (microliter)||Standard Deviation|Mean
176432|NCT00056407|Secondary|Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy|"The occurrence and quantity of high-grade prostatic intraepithelial neoplasia (HGPIN) and atypical small acinar proliferation (ASAP) at biopsy were measured. HGPIN and ASAP are considered precancerous conditions. A participant diagnosed with prostate cancer only (i.e., no HGPIN or ASAP) was counted in both the first category (HGPIN or prostate cancer diagnosis) and again in the last category (HGPIN, ASAP, or prostate cancer diagnosis)."|Baseline to Year 4|Biopsied Population: the number analyzed is the total number in the population||participants|||Number
176433|NCT00056407|Secondary|Number of Participants With the Indicated Gleason Score at Diagnosis|Gleason score was determined by examining prostate biopsies and surgical samples. The Gleason scoring system sums the two most common Gleason grade patterns in order to predict the likelihood of a participant doing well or badly with their cancer. Gleason grades range from 1 (normal) to 5 (advanced cancer). The lowest Gleason score is 2 (1+1), and the highest Gleason score is 10 (5+5). A Gleason score of 2-6 is a low-grade cancer; a Gleason score of 7-10 is high-grade cancer. The most severe high-grade cancers are the subset of Gleason scores 8-10.|Baseline to Year 4|Biopsied Population: all randomized participants with a negative entry biopsy who received at least 1 dose of study treatment and who had at least 1 biopsy reviewed by the central pathology lab. Only needle biopsies are included (surgeries are excluded). The number analyzed is smaller than the total number in the population due to missing values.||participants|||Number
176434|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)|Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk set at Years 1-2, Years 3-4, and Overall (Years 1-4) were those who had a biopsy during the specified time period.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population, restricted crude rate: the number of prostate cancer events is based on the the number of participants who had at least one biopsy during the time period. Ns at Years 1-2 and Years 3-4 are the number who had a biopsy in those time periods; the overall n is the number of participants who had 1 or more biopsy during Years 1-4.||participants|||Number
176435|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)|Study biopsies (biop.) consisted of 10 biop. samples (cores) in a pre-defined pattern and were read at the central pathology laboratory. Biop. cases that were positive for prostate cancer or precancerous lesions (HGPIN or ASAP) and prostate surgeries were reviewed by the lead pathologist. Participants included in the risk sets at Years 1-2 and Years 3-4 included those with a positive biop. at Years 1-2 or a biop. after Months 18-24, and those with a positive biop. at Years 3-4 or a biop. after Month 42, respectively. Overall included participants with a positive biop. or biop. after Month 42.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population, modified crude rate: participants who either were diagnosed with prostate cancer during the study or had an end of time period biopsy. N for each time period is the number who either had at least 1 biopsy in the final 6 months of the time period or had a positive biopsy anytime during the time period.||participants|||Number
176436|NCT00056407|Primary|Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)|Study biopsies consisted of 10 biopsy samples (cores) in a pre-defined pattern. Biopsies were read at the central pathology laboratory (CPL, which processed the majority, 94%, of biopsies). Biopsy cases that were positive for prostate cancer or precancerous lesions (high-grade prostatic intraepithelial neoplasia[HGPIN] or typical small acinar proliferation [ASAP]) and prostate surgeries were reviewed by the lead pathologist.|Years 1-2, Years 3-4, and Overall (Years 1-4)|Efficacy Population: all randomized participants with a negative entry biopsy, as determined by the CPL, who received at least 1 dose of study drug. The crude rate approach included all participants at risk at the beginning of each time period .||participants|||Number
176437|NCT00056316|Secondary|Secondary Outcome: Negative Affect Scale (Watson, Clark & Tellegen, 1988)|"10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = very slightly or not at all, and 5 = extremely. The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion."|Post-intervention, assessed 4-14 days after final intervention session.|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.||Points on a scale||Standard Deviation|Mean
176438|NCT00056316|Primary|Primary Outcome: Beck Depression Inventory II (Beck, Steer & Brown, 1996)|21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.|Post-intervention, assessed 4-14 days after final intervention session.|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.||Points on a scale||Standard Deviation|Mean
176439|NCT00056316|Secondary|Negative Affect Schedule (Watson, Clark & Tellegen, 1988)|"10 item self-report assessment of negative affects. Participants rate items on a scale from 1 to 5, based on the strength of emotion where 1 = very slightly or not at all, and 5 = extremely. The total continuous score may range from 10 to 50, with higher values indicative of stronger negative emotion."|Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention|All participants who were randomized into the study were included in the analyses (i.e., Intention to treat). Missing values were replaced with the Last Observation Carried Forward (LOCF) imputation method.||Points on a scale||Standard Deviation|Mean
176440|NCT00056316|Primary|Beck Depression Inventory II (Beck, Steer & Brown, 1996)|21-item self-report instrument to assess severity of symptoms of depression. There is a four-point scale for each item ranging from 0 to 3. The total continuous score can range from 0 to 63 points, with higher scores reflective of greater severity.|Pre-intervention intake assessment, conducted 7-14 days prior to start of intervention|All randomized participants||Points on a scale||Standard Deviation|Mean
176441|NCT00056160|Secondary|Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)|The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.|30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.||Weeks||Standard Deviation|Mean
176442|NCT00056160|Secondary|Myeloma Response|The overall confirmed response that was maintained for ≥6 weeks. Complete Response (CR):Disappearance of monoclonal paraprotein. Remission Response (RR):75-99% reduction in monoclonal paraprotein/90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR):50-74% reduction in monoclonal paraprotein/50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD):Criteria for PR or PD not met. Plateau Phase:If PR, stable monoclonal paraprotein (within 25% above or below nadir)/stable soft tissue plasmacytomas. Progressive Disease (PD):Disease worsens.|Up to Unblinding (07 Jun 2005)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized. Results reported (Response) are numbers of subjects.||Participants|||Number
176443|NCT00056160|Secondary|Overall Survival|Overall survival was calculated as the time from randomization to death from any cause.|170 weeks (median overall survival of CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.||Weeks||95% Confidence Interval|Median
176444|NCT00056160|Primary|Time to Tumor Progression (TTP)|Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.|60 weeks (median Time To Progression of CC-5013/Dex treatment group)|Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.||Weeks||95% Confidence Interval|Median
176445|NCT00055692|Other Pre-specified|Disease Stability||At 6 months||||||
176446|NCT00055692|Primary|To Collect Information on Hepatic Function and Hepatitis Viral Activity in Cirrhosis and Upon Potential Alterations in the Setting of VEGF-inhibition||During and after treatment|No data was collected by the principal investigator for this outcome|||||
176447|NCT00055692|Primary|Assessment on Circulating Levels of VEGF Which Also Contribute to HCC Pathogenesis and on Potential Alterations of These Levels in the Setting of VEGF-inhibition||During treatment|Six of eight patients were analyzed after 8 weeks of bevacizumab therapy||pg/mL||Standard Deviation|Mean
176448|NCT00055692|Primary|Mean Arterial Enhancement, Per Lesion, as Determined by Dynamic Gadolinium-enhanced Magnetic Resonance Imaging (MRI), Before and Following Bevacizumab Therapy.||Baseline and 8 weeks after bevacizumab therapy|Eight consecutive patients enrolled at one site were evaluated before and at 8 weeks after bevacizumab therapy with DCE-MRI.||relative MR units||Standard Deviation|Mean
176449|NCT00055692|Primary|Disease Response|MRI scan is required at weeks 8, 16 and then every 12 weeks until disease progression. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR|MRI is required at weeks 8, 16 and then every 12 weeks until disease progression|||participants||95% Confidence Interval|Number
176453|NCT00055601|Primary|Treatment Completion Rate|Radiation therapy and chemotherapy per protocol or within acceptable variation guidelines based on central review. The study was designed for a two-sided binomial test with 87% power and a significance level of 0.05 with a null hypothesis of a 70% completion rate against the alternative 90% completion rate. For each arm, more than 34 out of 43 evaluable patients completing the treatment, would indicate to reject the null hypothesis for a better treatment completion rate. Fewer than 24 out 43 evaluable patients completing the treatment would indicate to reject the null hypothesis for a worse treatment completion rate. Otherwise, the conclusion would be that there is not enough evidence to reject the null hypothesis of a 70% completion rate in either direction.|From randomization to 11 weeks|All eligible patients who started study treatment.||percentage of participants||95% Confidence Interval|Number
176454|NCT00055497|Secondary|Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF|"IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue all of the time) and 7=good quality on the item (e.g., feeling of fatigue none of the time). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life."|Change from Baseline of lead-in study to Week 24 and Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. OL adalimumab group was all participants assigned to the OL treatment who continued past Week 4. LOCF was used for missing data. 4 participants in OL group did not have IBDQ data at Baseline of lead-in study.||Scores on a scale||95% Confidence Interval|Mean
176455|NCT00055497|Secondary|Number of Participants Achieving CR-70 - LOCF|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF imputation was used for missing data.||Participants|||Number
176456|NCT00055497|Secondary|Number of Participants Achieving CR-100 - LOCF|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF was used for missing data.||Participants|||Number
176457|NCT00055497|Secondary|Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|||Participants|||Number
176458|NCT00055497|Secondary|Number of Participants Achieving Clinical Remission at Week 24 - LOCF|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 24|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Last observation carried forward (LOCF) was used for missing data.||Participants|||Number
176459|NCT00055497|Secondary|Number of Participants Achieving Clinical Response 70 (CR-70)- NRI|A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and to Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-70 not achieved) was used for missing data.||Participants|||Number
176460|NCT00055497|Secondary|Number of Participants Achieving Clinical Response 100 (CR-100) - NRI|A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|From Baseline of lead-in study to Week 24 and Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.||Participants|||Number
176501|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 40|Percentage of participants with Viral Load < 400 copies/mL|Week 40|||Percentage of participants|||Number
176502|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 32|Percentage of participants with Viral Load < 400 copies/mL|week 32|||Percentage of participants|||Number
176461|NCT00055497|Primary|Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Last observation carried forward was used for missing data.||Participants|||Number
176462|NCT00055497|Primary|Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.||Participants|||Number
176463|NCT00055497|Secondary|Number of OL Participants Achieving Clinical Remission at Week 56 - NRI|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 56|Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.||Participants|||Number
176464|NCT00055497|Secondary|Number of Participants Achieving Clinical Remission at Week 24 - NRI|Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's−related variables during a 1−week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.|Week 24|Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.||Participants|||Number
176465|NCT00055471|Secondary|Change in Urine Concentration of Type I Collagen-Cross Linked N Telopeptide (NTx)|Percentage change in urine concentration of Type I Collagen-Cross Linked N Telopeptide (NTx) (nmol BCE/mmol Creatinine) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054||Percentage Change||Standard Deviation|Mean
176466|NCT00055471|Secondary|Change in Serum Concentration of C-Terminal Telopeptide of Type I Collagen (CTx)|Percentage change in serum concentration of C-Terminal Telopeptide of Type I Collagen (CTx) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054||Percentage Change||Standard Deviation|Mean
176467|NCT00055471|Secondary|Change in Serum Concentration of Procollagen Type I N Propeptide (PINP)|"Percentage change in serum concentration of Procollagen Type I N Propeptide (PINP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2).~Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100"|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054||Percentage Change||Standard Deviation|Mean
176468|NCT00055471|Secondary|Change in Serum Concentration of Bone Alkaline Phosphatase (ALP)|Percentage change in serum concentration of Bone Alkaline Phosphatase (ALP) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2). Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054||Percentage Change||Standard Deviation|Mean
176469|NCT00055471|Secondary|Change in Total Prostate Specific Antigen (PSA)|"Percentage change in total Prostate Specific Antigen (PSA) (ng/mL) from baseline to Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2).~Percentage change = [(measure at Day 15 – measure at baseline)/measure at baseline]*100"|Baseline to Day 15.|The analysis population includes only patients dosed with ZD4054||Percentage Change||Standard Deviation|Mean
176470|NCT00055471|Secondary|Total Prostate Specific Antigen (PSA) Concentration|Total Prostate Specific Antigen (PSA) concentration at Day 15 (14 doses of study treatment per patient – no dose was administered on Day 2).|Baseline to Day 15.|All dosed patients.||ng/ml||Full Range|Geometric Mean
176471|NCT00055471|Primary|Dose Limiting Toxicities (DLTs)|"DLT is defined as experiencing Common Toxicity Criteria (CTC) grade 3 or 4 headache with onset within 24 h of receiving ZD4054, CTC grade 2 rhinitis leading to the withdrawal of the subject, or other CTC grade 3 or 4 toxicity that was considered to be related to ZD4054 treatment.~The numbers of patients with a DLT are reported."|Baseline to Day 29.|||Participants|||Number
176472|NCT00055237|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events, see the adverse event module.|70 months|"All adverse events regardless of attribution, over 202 cycles in 19 patients. Per protocol analysis of adverse events.~Cohort 1 and 2 are reported together."||Participants|||Number
176473|NCT00055237|Primary|Response Rate|Percentage of participants with a complete response (CR) + partial response (PR)per the Modified AIDS Clinical Trial Group Criteria (ACTG) for HIV-KS. PR is a 50% decrease in the number and/or size of previously existing lesions for 4 weeks; or complete flattening of at least 50% of all previously raised lesions lasting for at least 4 weeks; or a 50% decrease in the sum of the products of the largest perpendicular diameters of the marker lesions lasting for at least 4 weeks; CR is the absence of any detectable residual disease, including tumor associated edema, persisting for at least 4 weeks.|36 months|Cohort 2 is not reported here because response rate in HIV negative patients was a secondary outcome.||Percentage of participants||95% Confidence Interval|Mean
176474|NCT00054847|Secondary|Stroke||Within 1 year of bypass surgery|||participants|||Number
176477|NCT00054847|Primary|To Compare 1-year Angiographic Patency of Radial Artery Grafts Versus Saphenous Vein Grafts in Patients Undergoing Elective Coronary Artery Bypass Graft (CABG) Surgery.|The primary end point was angiographic graft patency at 1 year after coronary artery bypass surgery, defined as any opacification of distal target by injection of the graft. The window for the 1-year angiogram was 2 to 24 months. This window was chosen to capture early clinically indicated angiograms and late selective angiograms in patients who did not have symptoms. Study grafts that were occluded at 1 week after coronary artery bypass graft surgery were considered occluded at 1 year. One-year graft patency data were missing if patients whose study grafts were patent at 1 week did not undergo an angiogram within the time window or if the central angiography laboratory was not able to determine graft patency.|1 year|All analyses were performed according to intention to treat. The study was designed to have 90%power to detect 1-year patency rates of 92% in radial artery vs 83% in saphenous vein grafts, with a 2-sided type I error of 5% and an expected 1-year catheterization completion rate of 65%. .||grafts|Participants||Number
176478|NCT00054717|Secondary|Percentage of Patients With Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 or 4 Laboratory Abnormalities|NIH Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading Severity of Adult Adverse Experiences, December 2004.|240 Weeks|Safety Analysis Set with On-Treatment data (SAF-OT), all patients treated with at least one dose of study drug and have on-treatment laboratory values||Percentage of participants|||Number
176479|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 96|Percentage of participants with Viral Load < 50 copies/mL|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176480|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 88|Percentage of participants with Viral Load < 50 copies/mL|Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176481|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 80|Percentage of participants with Viral Load < 50 copies/mL|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176482|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 72|Percentage of participants with Viral Load < 50 copies/mL|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176483|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 64|Percentage of participants with Viral Load < 50 copies/mL|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176484|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 56|Percentage of participants with Viral Load < 50 copies/mL|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176485|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 48|Percentage of participants with Viral Load < 50 copies/mL|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176486|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 40|Percentage of participants with Viral Load < 50 copies/mL|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176487|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 32|Percentage of participants with Viral Load < 50 copies/mL|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176488|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 24|Percentage of participants with Viral Load < 50 copies/mL|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176489|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 16|Percentage of participants with Viral Load < 50 copies/mL|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176490|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 8|Percentage of participants with Viral Load < 50 copies/mL|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176491|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 4|Percentage of participants with Viral Load < 50 copies/mL|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176492|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Week 2|Percentage of participants with Viral Load < 50 copies/mL|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176493|NCT00054717|Secondary|Virologic Response (VL < 50 Copies/ml) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load < 50 copies/mL|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176494|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 96|Percentage of participants with Viral Load < 400 copies/mL|week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176495|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 88|Percentage of participants with Viral Load < 400 copies/mL|week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176496|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 80|Percentage of participants with Viral Load < 400 copies/mL|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176497|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 72|Percentage of participants with Viral Load < 400 copies/mL|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176498|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 64|Percentage of participants with Viral Load < 400 copies/mL|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176507|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Week 2|Percentage of participants with Viral Load < 400 copies/mL|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176508|NCT00054717|Secondary|Virologic Response (VL < 400 Copies/ml) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load < 400 copies/mL|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176509|NCT00054717|Secondary|Time to New CDC Class C Progression Event or Death.|Time to new Centers for Disease Control and Prevention (CDC) class C progression event (i.e., new AIDS defining illness) or death|after 48 weeks of treatment|Safety Analysis Set (SAF), includes all patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
176510|NCT00054717|Secondary|Mean Change From Baseline to Week 96 in CD4+ Cell Count||Baseline to Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176511|NCT00054717|Secondary|Mean Change From Baseline to Week 88 in CD4+ Cell Count||Baseline to Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176512|NCT00054717|Secondary|Mean Change From Baseline to Week 80 in CD4+ Cell Count||Baseline to Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176513|NCT00054717|Secondary|Mean Change From Baseline to Week 72 in CD4+ Cell Count||Baseline to Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176514|NCT00054717|Secondary|Mean Change From Baseline to Week 64 in CD4+ Cell Count||Baseline to Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176515|NCT00054717|Secondary|Mean Change From Baseline to Week 56 in CD4+ Cell Count||Baseline to Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176516|NCT00054717|Secondary|Mean Change From Baseline to Week 48 in CD4+ Cell Count||Baseline to Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176517|NCT00054717|Secondary|Mean Change From Baseline to Week 40 in CD4+ Cell Count||Baseline to Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176518|NCT00054717|Secondary|Mean Change From Baseline to Week 32 in CD4+ Cell Count||Baseline to Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176519|NCT00054717|Secondary|Mean Change From Baseline to Week 24 in CD4+ Cell Count||Baseline to Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176520|NCT00054717|Secondary|Mean Change From Baseline to Week 16 in CD4+ Cell Count||Baseline to Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176521|NCT00054717|Secondary|Mean Change From Baseline to Week 8 in CD4+ Cell Count||Baseline to Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176522|NCT00054717|Secondary|Mean Change From Baseline to Week 4 in CD4+ Cell Count||Baseline to Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176523|NCT00054717|Secondary|Mean Change From Baseline to Week 2 in CD4+ Cell Count||Baseline to Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Cells/mm3||Standard Deviation|Mean
176524|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 96||Baseline to Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
176525|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 88||Baseline to Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
176526|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 80||Baseline to Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
176527|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 72||Baseline to Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
176528|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 64||Baseline to Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
176529|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 56||Baseline to Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
176530|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 48||Baseline to Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
176531|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 40||Baseline to Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
176532|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 32||Baseline to Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
176533|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 24||Baseline to Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
176534|NCT00054717|Secondary|Median Change From Baseline in Viral Load to Week 16||Baseline to Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Log(Copies/mL)||Inter-Quartile Range|Median
176538|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 64|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176539|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 56|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176540|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 48|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176541|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 40|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176542|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 32|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176543|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 24|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176544|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 16|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176545|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 8|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176546|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 4|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176547|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Week 2|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176548|NCT00054717|Secondary|Virologic Response (Viral Load >= 1 Log Drop) at Viral Load Nadir, LOCF|Percentage of participants with Viral Load (VL) >= 1 log reduction from baseline|Week 2 through Week 96 (at any point during trial)|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176549|NCT00054717|Secondary|Time to Confirmed Virologic Failure Through 96 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
176550|NCT00054717|Secondary|Time to Confirmed Virologic Failure Through 48 Weeks of Treatment|Time to virologic failure is defined as the time from the start of treatment to the last measurement with a viral load reduction greater than 1.0 log before a confirmed drop of viral load reduction below 1.0 log.|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
176551|NCT00054717|Secondary|Time to Treatment Failure Through 96 Weeks of Treatment|time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
176552|NCT00054717|Secondary|Treatment Response at Week 96|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 96|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176553|NCT00054717|Secondary|Treatment Response at Week 88|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 88|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176554|NCT00054717|Secondary|Treatment Response at Week 80|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 80|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176555|NCT00054717|Secondary|Treatment Response at Week 72|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 72|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176556|NCT00054717|Secondary|Treatment Response at Week 64|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 64|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176557|NCT00054717|Secondary|Treatment Response at Week 56|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 56|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176558|NCT00054717|Secondary|Treatment Response at Week 48|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176559|NCT00054717|Secondary|Treatment Response at Week 40|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 40|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176560|NCT00054717|Secondary|Treatment Response at Week 32|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 32|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176561|NCT00054717|Secondary|Treatment Response at Week 24|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176562|NCT00054717|Secondary|Treatment Response at Week 16|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 16|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176563|NCT00054717|Secondary|Treatment Response at Week 8|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 8|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Percentage of participants|||Number
176564|NCT00054717|Secondary|Treatment Response at Week 4|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 4|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176565|NCT00054717|Secondary|Treatment Response at Week 2|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|week 2|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176566|NCT00054717|Secondary|Treatment Response at Week 24|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|Week 24|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176567|NCT00054717|Primary|Time to Treatment Failure Through 48 Weeks of Treatment|Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with VL measurements <1 log10 below baseline.|Week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||Days||Inter-Quartile Range|Median
176568|NCT00054717|Primary|Treatment Response at Week 48|Treatment response (TR) is defined as two consecutive VL ≥ 1 log10 below baseline without discontinuation of study drug, change in anti-retroviral background, or rebound|At week 48|FAS, Full Analysis Set includes all randomized patients treated with at least one dose of study medication||percentage of participants|||Number
176569|NCT00054704|Primary|Montgomery-Asberg Depression Rating Scale|The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated assessment of depression symptoms. Patients were rated weekly on 10 symptoms on a scale of 0 to 6 for each item, where 0 indicated no symptoms and 6 indicated the highest severity of that symptom. Total scores range from 0 to 60, where a moderate severity of depression would be present with a score of at least 20.|8 weeks|Data from all patients were included in the analysis.||Units on a scale||Standard Error|Least Squares Mean
176570|NCT00054691|Secondary|Duration of Response|Response duration was defined as the time from initial response during therapy to progression of disease.|Every 8 weeks till disease progression.|Out of 40 participants, 19 participants had progressive disease, 2 participants had unmeasurable disease and 1 participant was noncompliant.||months||Full Range|Median
176571|NCT00054691|Primary|Number of Participants With Objective Response (Partial Response, Stable Disease and Progressive Disease)|Responses were assessed according to the Union Internationale Contre le Cancer (UICC) / World Health Organization (WHO) criteria. Objective response (measurable response) defined as: Partial response (PR): Applies only to participants with at least 1 measurable lesion; >/=50% decrease under baseline in sum of products of perpendicular diameters of all measurable lesions. Stable Disease (SD): No progression of evaluable disease and/or no new lesions. Progressive Disease (PD): 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease.|Every 8 weeks till disease progression.|Out of 40 participants, 2 participants had unmeasurable disease and 1 participant was noncompliant.||participants|||Number
176572|NCT00054665|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|43 months|||Participants|||Number
176573|NCT00054665|Primary|Clinical Response Rate|Clinical Response Rate is the number of participants with a partial and complete response assessed by the criteria for lymphoma. A complete response is complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy and normalization of those biochemical abnormalities. Partial response is a greater than or equal to 50% decrease in the sum of the products of the greatest diameters of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease|18 weeks|||Participants|||Number
176574|NCT00054639|Primary|Number of Patients With Objective Response|Efficacy as measured by objective response complete (CR) and partial (PR) response rates at 2 months following study treatment|2 months following study treatment|Analysis was per protocol. Of the 48 participants enrolled, only 42 were evaluable for response.||participants|||Number
176575|NCT00054327|Post-Hoc|Number of Patients With Overall Survival at 2 Years.||at 2 years from transplant|||participants|||Number
176576|NCT00054327|Secondary|Toxicity as Measured by CTC v2.0|Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities.|at 100 days post transplant|||participants|||Number
176577|NCT00054327|Secondary|Incidence of Recurrent Disease|Number of patients that have disease recurrence.|at day 100 post transplant|||participants|||Number
176578|NCT00054327|Secondary|Graft-versus-host Disease (GVHD)|Number of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe.|at 100 days post transplant|||participants|||Number
176579|NCT00054327|Primary|Rates of Durable Engraftment|Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC >500/µl and platelets >20K/µl without transfusion support.|at day 42|||days||Standard Deviation|Mean
176580|NCT00054275|Secondary|Overall Survival as of 2008|Overall survival (OS) was defined as time from the start of treatment to death, and censored at the time of last assessment for survivors.|5 yrs|Including 10 patients with only 1 cycle of treatment||months||95% Confidence Interval|Median
176581|NCT00054275|Secondary|Progression Free Survival(PFS)|Progression free survival was defined as time from the start of treatment to the date of cancer progression, or death, and censored at the date of last follow-up for those without disease progression and still alive. Stable disease is measured from the start of the treatment until progression, taking as reference the smallest measurements recorded since the treatment started. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|3 years|||months||95% Confidence Interval|Median
176582|NCT00054275|Primary|Disease Response (Tumor Measurements)Per RECIST Criteria v. 2000|Response and progression will be evaluated in this study using the criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive Disease: At least a 20% increase in the sum of the LD of target lesions. Stable Disease: Neither sufficient shrinkage nor sufficient increase.|after 6 course (6 months) of combination therapy|Excluding 11 not evaluable cases||participants|||Number
176583|NCT00054028|Secondary|Response as Measured by RECIST Criteria|Evaluation of secondary endpoints will be primarily descriptive. Descriptive data will be computed and compared using analysis of variance and non-parametric rank equivalents for continuous data and chi-square or Fisher's exact test for discrete data. Response rates will include 95% confidence limits.|Up to 5 years|Objective Response Rate||percentage of patients|||Number
176584|NCT00054028|Primary|Objective Response Rate (Complete Response and Partial Response) as Measured by RECIST Criteria (Phase II)|Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0) for target lesion s and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR+PR.|Up to 8 weeks|||patients|||Number
176585|NCT00054028|Primary|Percentage of Patients That Achieved Target Suramin Concentrations in Plasma|Target suramin concentration was considered achieved, if at least 5 of 6 patients achieved the target plasma concentration of 10-50 µM over the duration of 8-48 hours when paclitaxel levels are therapeutic.|Up to 5 years|||percent of patients|||Number
176586|NCT00053846|Primary|Dyspnea as Measured by Oxygen Cost Diagram (OCD)|OCD was used to evaluate dyspnea on exertion and activities of daily living. OCD is a visual analog scale for quantifying a patient's evaluation of tolerance of exertion, which corresponds to oxygen requirements at different activity levels. It is measured as a score of 2 (sleeping) to 14 (brisk walking uphill). HIgher scores indicate fewer limitations due to dyspnea.|28 days after beginning study drug or placebo|||units on a scale||Standard Deviation|Mean
176587|NCT00053703|Secondary|Change From Baseline in Body Mass Index Change, kg/m2, at Week 8|Change from baseline in Body Mass Index Change, kg/m2, at week 8, last observation was carried forward for individuals who withdrew from treatment early.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.||kg/m2||Standard Deviation|Mean
176588|NCT00053703|Primary|Change From Baseline in PANSS Negative Symptom Subscale at Week 8|The PANSS (described above) includes 7 items that reflect negative psychotic symptoms such as amotivation and social withdrawal. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.|8 weeks|||units on a scale||Standard Deviation|Mean
176589|NCT00053703|Primary|Change From Baseline in PANSS Positive Symptom Subscale Score at 8 Weeks.|The PANSS (described above) includes 7 items that reflect positive psychotic symptoms such as hallucinations and delusions. As are all items within the PANSS, items are categorically rated by the clinician between 0 - no symptoms to 7 extreme symptoms. The minimal score is 0 reflecting no positive symptoms to 49 reflecting that all items were extreme. Higher scores reflect more severe symptoms. Scores above 18 are usually clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.||units on a scale||Standard Deviation|Mean
176590|NCT00053703|Secondary|Change From Baseline in Barnes Akathisia Scale at Week 8|Barnes Akathisia Scale is a clinician rated scale which considers information based on observation of the participant as well as participant report. The scale includes 3 items rated between 0- none to 3 severe and 1 summary item rated between 0 none to 5 severe. All items are summed to obtain the total score. The minimal total score is 0 and the maximal score is 14 with higher scores reflecting more severe akathisia. A score of 4 or more is clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.||units on a scale||Standard Deviation|Mean
176592|NCT00053703|Primary|Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at 8 Weeks|Assessed with the Positive and Negative Syndrome Scale in which a clinician rates various psychotic symptoms on the basis of observation of the participant, interview with the participant, and review of all other available information including informant reports. The scale consists of 30 items which are rated categorically between 1 - no symptoms to 7 - extreme symptoms. The minimal score is 0 and the maximal score is 210, with higher scores reflecting more symptoms. Typically scores > that 60 are considered clinically significant.|8 weeks|All randomized patients who took at least one dose of drug and had at least one post-baseline assessment.||units on a scale||Standard Deviation|Mean
176593|NCT00053495|Other Pre-specified|Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 (baseline) and 15 post-vaccination|Hematology parameters were evaluated in the safety, intent-to-treat population.||x10-6th/μL||Standard Deviation|Mean
176594|NCT00053495|Other Pre-specified|Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 (baseline) and 15 post-vaccination|Hematology parameters were evaluated in the safety, intent-to-treat population.||Percentage (%)||Standard Deviation|Mean
176595|NCT00053495|Primary|Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination|Plaque-reduction neutralization test (PRNT50) titers were determined in the antibody evaluable, per-protocol population||Participants|||Number
176596|NCT00053495|Other Pre-specified|Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in safety, intent-to-treat population||mg/dL||Standard Deviation|Mean
176597|NCT00053495|Other Pre-specified|Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in safety, intent-to-treat population||IU/L||Standard Deviation|Mean
176598|NCT00053495|Other Pre-specified|Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Days 0 to 30 post-vaccination|Treatment-emergent rash events were assessed in the safety, intent-to-treat population.||Participants|||Number
176599|NCT00053495|Primary|Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination|Neutralizing antibody response titers were evaluated in the antibody evaluable, per-protocol population.||PRNT50 Titers||Standard Deviation|Mean
176600|NCT00053495|Primary|Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine|The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.|Days 0 to 30 post-vaccination|Adverse events were assessed in the safety, intent-to-treat population||Participants|||Number
176601|NCT00053482|Other Pre-specified|Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in the intent-to-treat safety population||IU/L||Standard Deviation|Mean
176602|NCT00053482|Other Pre-specified|Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|Clinical chemistry parameters were assessed in the intent-to-treat safety population||mg/dL||Standard Deviation|Mean
176603|NCT00053482|Other Pre-specified|Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|The hematology parameters were assessed in the intent-to-treat safety population.||x10^6th/µL||Standard Deviation|Mean
176604|NCT00053482|Other Pre-specified|Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 (Baseline) and 15 post-vaccination|The hematology parameters were assessed in the intent-to-treat safety population.||Percentage (%)||Standard Deviation|Mean
176605|NCT00053482|Other Pre-specified|Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 to 30 post-vaccination|Treatment-emergent rash events were assessed in the safety intent-to-treat population.||Participants|||Number
176606|NCT00053482|Primary|Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine||Days 0 to 30 post-vaccination|Post-vaccination adverse events were assessed in the safety, intent-to-treat population.||Participants|||Number
176607|NCT00053482|Primary|Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.||Day 30 post-vaccination|||Participants|||Number
176608|NCT00053482|Primary|The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine|The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)|Day 30 post-vaccination|The neutralizing antibody response titers were assessed in the antibody evaluable, per-protocol population.||PRNT50 Titers||Standard Deviation|Mean
176609|NCT00053417|Primary|Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test|The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).|Baseline (placebo run-in period); 12-week stable dose period|||percent change||Full Range|Median
176610|NCT00053365|Secondary|Duration of Progression-free Survival||From study entry until disease progression, death or date of last contact, assessed up to 5 years||||||
176628|NCT00051636|Secondary|Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10|The percent change in serum C-telopeptide from baseline to day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.||percent change||Standard Deviation|Mean
176611|NCT00053365|Secondary|Overall Survival and Progression-free Survival|Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria, progression is defined as at least a 20% increase in the sum of longest dimesions(LD) of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.|From entry into study to death or date of last contact, assessed up to 5 years|||months||95% Confidence Interval|Median
176612|NCT00053365|Primary|Frequency and Severity of Observed Adverse Events, Graded According to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0||Up to 5 years||||||
176613|NCT00053365|Primary|Tumor Response|"Per Gynecologic Oncology Group(GOG) Response Evaluation Criteria in Solid Tumors(RECIST) Criteria: Complete Response is disappearance of all target and non-target lesions; Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable dimensions; Increasing Disease is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Response is to be evaluated every 42 days for the first 6 months and every 6 months thereafter while the patient is receiving study treatment, then every 3 months for 2 years and every 6 months for the next 3 years until documented progression or death."|From entry into study until documented progression or death, assessed up to 5 years.|||participants|||Number
176614|NCT00053014|Secondary|Serious Adverse Events|Twice a week for the first two months, one time a week during month 3, one time every two weeks for months 4-9.|9 months|All patients||participants|||Number
176615|NCT00053014|Primary|Overall Survival|measured from date of registration to study until death from any cause with patients still alive censored at date of last contact|1 year|||participants|||Number
176616|NCT00052962|Secondary|Number of Participants With an Adverse Event|Here is the number of participants with an adverse event. For a detailed list of adverse events see the adverse event module.|2003-2008|Three participants were not included in the analysis because one participant was not randomized/not evaluable, two were not evaluable, and/or information is not known.||Participants|||Number
176617|NCT00052962|Primary|Progression Free Survival|"CHPP is administered as a heated cisplatin solution delivered to the abdomen through a catheter (plastic tube), washed through the abdomen for 90 minutes, and then drained out of the body through another catheter.~Progression is defined as imageable tumor nodules or increasing ascites persistent on two serial computed tomography (CT) scans."|2003-2008|Study was closed July 2008 because the PI left the institution, thus the objective was not met.|||||
176618|NCT00052429|Primary|Local Control of Participants|Patients will be classified as controlled as long as there is no clinical or radiographic evidence of disease progression. Physical exam with fiberoptic nasopharyngoscopy will be performed approximately every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.|every 3 months in the first year of follow-up, every 4 months in the second year, every 6 months in the third-fifth years and annually, thereafter.|||percentage of participants|||Number
176619|NCT00052429|Primary|Survival Rate of Patients|Patients will be followed indefinitely and will have standard screening for development of distant metastases, including physical exam, as well as liver function tests and a chest radiograph annually. Patients will be classified as progression free as long as they remain alive with local, regional or distant recurrence.|up to 77 months|||months||Full Range|Median
176620|NCT00051636|Secondary|Number of Participants With a Disease Relapse During the Extended Observation Period|Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||Participants|||Number
176621|NCT00051636|Secondary|Number of Participants With a Partial Disease Relapse During the Extended Observation Period|Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase >= 50% from the serum alkaline phosphatase measurement at month 6 and at least 1.25 times the upper normal limit.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||Participants|||Number
176622|NCT00051636|Secondary|Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period|Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase.|8 years was the maximum|Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.||Participants|||Number
176623|NCT00051636|Secondary|Change in Pain Interference Score|Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.||Units on a scale||Standard Deviation|Mean
176624|NCT00051636|Secondary|Change in Pain Severity Score|Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain.|Baseline and day 182|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis.||Units on a scale||Standard Deviation|Mean
176625|NCT00051636|Secondary|Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline|Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range.|Baseline and day 28|Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis.||Participants|||Number
176626|NCT00051636|Secondary|Time to First Therapeutic Response|A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.|182 days|Intent-to-treat population: all randomized patients.||Days||Inter-Quartile Range|Median
176627|NCT00051636|Secondary|Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10|The percent change in urine alpha C-telopeptide from baseline to day 10 was measured.|Baseline and day 10|Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis.||Percent change||Standard Deviation|Mean
176629|NCT00051636|Secondary|Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28|The percent change in serum alkaline phosphatase from baseline to day 28 was measured.|Baseline and day 28|Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis.||percent change||Standard Deviation|Mean
176630|NCT00051636|Primary|Number of Patients Who Achieve Therapeutic Response at 6 Months.|Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months.|6 months|Modified intent to treat population: all randomized patients with both baseline and at least one post-baseline serum alkaline phosphatase measurement. Missing values at 6 months were imputed using the last post-baseline measurement prior to 6 months.||participants|||Number
176631|NCT00051558|Secondary|Any Fracture, Nonvertebral Fractures, Vertebral Fractures, Clinical Vertebral Fractures, and Severity Fractures|Clinical vertebral fracture was defined as a radiographically confirmed fracture that was associated with symptoms such as back pain.|36 months|For vertebral fractures, only those patients with baseline and postbaseline spinal radiographs were included in the analysis.||participants|||Number
176632|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Osteocalcin||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers||percent||Standard Error|Mean
176633|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum Type 1 Collagen Degradation Fragments||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers||percent||Standard Error|Mean
176634|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Bone-Specific Alkaline Phosphatase||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers||percent||Standard Error|Mean
176635|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum C-terminal Propeptide of Type 1 Procollagen||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers.||percent||Standard Error|Mean
176636|NCT00051558|Secondary|Time Course of Change From Baseline in Bone Turnover Markers in Subset of Patients - Serum N-terminal Propeptide of Type 1 Procollagen||1, 6, 18, and 36 months|Subset of patients with measures of biochemical markers||percent||Standard Error|Mean
176637|NCT00051558|Secondary|Time Course of Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)|12, 18, 24, and 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data was imputed.||grams per square centimeters||Standard Error|Least Squares Mean
176638|NCT00051558|Secondary|Time Course of Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)|12, 18, 24, and 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.||grams per square centimeters||Standard Error|Least Squares Mean
176639|NCT00051558|Secondary|Change From Baseline in Total Hip Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the total hip as assessed by dual energy X-ray absorptiometry (DXA)|18, 24, 36 months, and 18 and 36 month endpoints|The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However, at 18 and 36 month endpoints, last observation carried forward analyses were applied.||grams per square centimeters||Standard Error|Least Squares Mean
176640|NCT00051558|Secondary|Change From Baseline in Femoral Neck Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the femoral neck as assessed by dual energy X-ray absorptiometry (DXA)|18, 24, 36 months, and 18 and 36 month endpoints|The intention-to-treat analysis was performed using all randomized and treated patients. For 18, 24 and 36 month time points, no missing data were imputed. However at the 36 month endpoint, last observation carried forward analysis was applied.||grams per square centimeters||Standard Error|Least Squares Mean
176641|NCT00051558|Secondary|Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|24 and 36 months and Endpoint at 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. For 24 and 36 month time points, no missing data were imputed. However, at the 36 month endpoint, last observation carried forward analysis was applied.||grams per square centimeters||Standard Error|Least Squares Mean
176642|NCT00051558|Secondary|Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Female Subset|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|3, 6, 12, and 18 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.||grams per square centimeters||Standard Error|Least Squares Mean
176643|NCT00051558|Secondary|Time Course of Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), Women and Men Combined|change from baseline in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|3, 6, 12, 18, 24, 36 months|The intention-to-treat analysis was performed using all randomized and treated patients. No missing data were imputed.||grams per square centimeters||Standard Error|Least Squares Mean
176644|NCT00051558|Secondary|Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD), Female Subset|change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|18 month endpoint|The intention-to-treat analysis was performed using all randomized and treated patients (female only subset).||grams per square centimeters||Standard Error|Least Squares Mean
176645|NCT00051558|Primary|Change From Baseline at 18 Month Endpoint in Lumbar Spine Bone Mineral Density (BMD)|change from baseline at endpoint in bone mineral density of the lumbar spine as assessed by dual energy X-ray absorptiometry (DXA)|18 month endpoint|The intention-to-treat analysis was performed using all randomized and treated patients.||grams per square centimeters||Standard Error|Least Squares Mean
176646|NCT00051363|Other Pre-specified|Functional Magnetic Resonance Imaging (fMRI)||Measured at diagnostic visit (baseline) and 6 months post intervention|fMRI was dropped as a secondary outcome measure for analysis by our Core Team.|||||
176647|NCT00051363|Secondary|Quality of Life: Calgary Sleep Apnea Quality of Life Index- Total Score (SAQLI-TS)|Quality of life was measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI), which is an interview-administered instrument with high internal consistency and reliability. The SAQLI was designed to assess components identified as important to patients including daily functioning, social interactions, emotional functioning, symptoms experienced, and treatment-related symptoms. Items are scored on a seven-point scale, averaged (taking into account treatment-related symptoms), to yield a composite score between 1 and 7, where higher scores represent better quality of life.|diagnostic visit (baseline)|Analyses performed for group of participants with SAQLI data. Baseline demographics were generally similar (mean age, sex ratio, proportion of white participants, average body mass index), and participants in both groups had similar SAQLI scores at baseline, which are presented below.||Units on a scale||Standard Deviation|Mean
176648|NCT00051363|Secondary|Mood||Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Mood was dropped as a secondary outcome measure for analysis by our Core Team.|||||
176649|NCT00051363|Secondary|Subjective Sleepiness/Alertness: Epworth Sleepiness Scale- Total Score (ESS-TS)|"Subjective sleepiness/alertness was measured using the Epworth Sleepiness Scale (ESS); the outcome variable was ESS Total Score (ESS-TS).~The ESS is a validated questionnaire (8 questions) that ask the chances of dozing off in specific situations. Summing the scores produces a scaled total score between 0 and 24, with higher numbers indicating more subjective sleepiness. The ESS was administered the evening before the polysomnogram (PSG), or overnight sleep study. Data reported here include questionnaires collected at the DX, 2M, and 6M visits."|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||scores on a scale||Standard Deviation|Mean
176650|NCT00051363|Secondary|Objective Sleepiness/Alertness: Maintenance of Wakefulness Test- Mean Sleep Latency (MWT-MSL)|"Objective sleepiness/alertness was measured using the Maintenance of Wakefulness Test (MWT); the outcome variable was MWT Mean Sleep Latency (MWT-MSL).~The MWT was administered using four twenty-minute trials where the participant was asked to sit in a chair, in a quiet and dimly lit room, with instructions to stay awake. Trials were performed at 10 AM, Noon, 2 PM and 4 PM. The mean sleep latency was calculated using the 4 trials from a given visit, and required that at least 3 of the 4 trials were performed and validated."|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||minutes||Standard Deviation|Mean
176651|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD), SWMT- Mid-day Activation Index (SWMT-ActMD), and Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh).~These data are for variable #3: Shifting Attention Test Discovery Condition- Number of Rule Changes (SAT-D-NumRuCh)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||number of rule changes (dichotomized)||95% Confidence Interval|Mean
176652|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: SWMT- Mid-day Activation Index (SWMT-ActMD)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh.~These data are for variable #2: SWMT- Mid-day Activation Index (SWMT-ActMD)~SWMT-ActMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline (BL) using standard deviation units. It is computed as the difference from BL relative to EEG power spectral variables (decibels) measured during the easier vs. more difficult working memory (WM) tasks. A positive activation sub-score indicates a larger cortical neuronal population was recruited to perform the more difficult WM task relative to BL, while a negative score indicates a smaller population was recruited."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||score on a scale||95% Confidence Interval|Mean
176653|NCT00051363|Secondary|Executive and Frontal-Lobe (E/F) Function: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Executive and Frontal-Lobe (E/F) Function: SWMT-BehMD, SWMT-ActMD, and SAT-D-NumRuCh.~These data are for variable #1: Sustained Working Memory Test- Mid-day Behavioral Index (SWMT-BehMD)~SWMT-BehMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the difference from baseline relative to measures of working memory (WM) task performance accuracy (percent correct) and mean and standard deviation of reaction time (milliseconds). High-load WM tasks receive twice the weight of the low-load WM tasks."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||score on a scale||95% Confidence Interval|Mean
176654|NCT00051363|Secondary|Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec)|The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. One of the selected variables came from the domain of Learning and Memory (L/M) Function: Buschke Selective Reminding Test Delayed Recall- Total Recall (BSRTDR-TotRec).|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||number of words recalled||95% Confidence Interval|Mean
176655|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).~These data are for variable #3: PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||milliseconds||95% Confidence Interval|Mean
176656|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).~These data are for variable #2: Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||milliseconds||95% Confidence Interval|Mean
176657|NCT00051363|Secondary|Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT)|"The APPLES a priori Secondary Neurocognitive Analysis Plan specified a dimension reduction method to reduce twelve secondary neurocognitive variables from three neurocognitive domains to seven variables from three neurocognitive domains. Three of the selected variables came from the domain of Attention and Psychomotor (A/P) Function: Pathfinder Number- Reaction Time (PN-RT), Psychomotor Vigilance Task- Median Reaction Time (PVT-MedRT), and PVT- Mean Slowest 10% of Reaction Times (PVT-Slo10%RT).~These data are for variable #1: Pathfinder Number- Reaction Time (PN-RT)"|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle. Analyses performed by OSA severity level categorized by apnea hypopnea index (AHI: # of respiratory events/hr of sleep) obtained via baseline polysomnography. Categories are: Mild OSA (AHI = 10-14.9; exclusion if AHI <10), Moderate OSA (AHI = 15-29.9), Severe OSA (AHI >=30).||seconds||95% Confidence Interval|Mean
176658|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: L/M Function- BSRT-SR|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).~This is domain #3: Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR)"|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.||number of words recalled||95% Confidence Interval|Mean
176659|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: A/P Function- PFN-TOTL|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).~This is domain #2: Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL)"|Measured at diagnostic visit (baseline) and 2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.||seconds||95% Confidence Interval|Mean
176660|NCT00051363|Primary|Effect of CPAP on Neurocognitive Function: E/F Function- SWMT-OMD|"There are three primary measures of neurocognitive function measured for APPLES, each representing a different domain: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD), Attention and Psychomotor (A/P) Function- Pathfinder Number Test Total Time (PFN-TOTL), and Learning and Memory (L/M) Function- Buschke Selective Reminding Test Sum Recall (BSRT-SR).~This is domain #1: Executive and Frontal-lobe (E/F) Function- Sustained Working Memory Test Overall Mid-Day Index (SWMT-OMD)~SWMT-OMD is a scaled score that indicates whether the participant scored lower or higher relative to baseline using standard deviation units. It is computed as the mean of three sub-scores, one based on working memory (WM) task performance (behavioral WM sub-score: speed, accuracy), and the other two on electroencephalogram (EEG) (cortical activation sub-score: neural workload, attentional effort during WM task; alertness sub-score: resting alertness)."|2 months and 6 months post intervention|Analyses conducted in accordance with the intention-to-treat principle.||score on a scale||95% Confidence Interval|Mean
176661|NCT00051168|Primary|Mean Intraocular Pressure|"Mean IOP for the patient’s worse eye at baseline was used in the secondary endpoint analysis. 2 consecutive IOP measurements for each eye were taken. If the 2 measurements for the same eye differ by 4 mmHg or less, the average of the measurements would be considered as the mean IOP for that eye. If the 2 measurements for the same eye differ by more than 4 mmHg, then a third measurement was to be taken.~All IOP measurements were performed with a Goldmann applanation tonometer."|At 5 years.|||millimeters mercury (mm Hg)||Standard Deviation|Mean
176662|NCT00050167|Secondary|Treatment Effectiveness at Eradicating Tumor in the Breast and Lymph Nodes|Effectiveness defined as proportion of patients who were able to have breast conserving surgery (BCS) after preoperative therapy compared to total number of participants.|7 years||||||
176663|NCT00050167|Secondary|Proportion of Participants With Pathological Complete Response|Safety of 2 Different Treatments determined by proportion of participants who achieved pathological complete response (pCR) between two different treatments; where pCR was defined as no histopathologic evidence of any residual invasive cancer cells in the breast and axillary lymph nodes.|7 Years||||||
176664|NCT00050167|Primary|Percentage of Participants With Reoccurrence|Percentage of participants where number with local recurrence, distant metastasis, or death of any cause at 50 months is divided by total number of participants and used as primary efficacy end point to compare paclitaxel to combination docetaxel and capecitabine in breast cancer treatment for preventing recurrence (return of cancer).|Median of 50 months|"(WP Arm):301 included in the intent to treat analysis and 297 included in the safety analysis.~(DX Arm):300 included in the intent to treat analysis and 292 included in the safety analysis."||participants||95% Confidence Interval|Log Mean
176665|NCT00051025|Secondary|Time-to-Treatment Failure||From start of first treatment||||||
176666|NCT00051025|Secondary|Duration of Response|The duration of response was defined as the time interval from start of the first response (CR or PR) to the time of documented disease progression.|From beginning of response to time of relapse|Intent-to-treat. Please note: Data represent 1 subject in each treatment group who responded.||Days|||Number
176667|NCT00051025|Primary|Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8.|Complete response: achievement of a complete regression for >4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for >4 weeks and had indeterminate bone marrow biopsy|24 Weeks|Intent-to-treat||Participants|||Number
176668|NCT00050986|Secondary|Progression-free Survival (Phase II)|Efficacy measured by 6 month progression-free survival assessment.|6 months||||||
176669|NCT00050986|Primary|Maximal Tolerating Dose (MTD for Phase I)|"Phase I Dose limiting toxicity evaluation at end of first cycle based on blood tests every two weeks and participants' subjective and objective symptoms.~Start Dose Level 100 mg/m² Temozolomide once daily + 400 mg ZARNESTRA twice daily; Dose Level 1 100 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 2 150 mg/m² Temozolomide once daily + 500 mg ZARNESTRA twice daily; Dose Level 3 150 mg/m² Temozolomide once daily + 600 mg ZARNESTRA twice daily; Dose Level 4 150 mg/m² Temozolomide once daily + 800 mg ZARNESTRA twice daily"|End of first cycle (4 weeks) evaluation|As treated.||participants|||Number
176670|NCT00050960|Primary|Overall Survival||From date of randomization to date of death|Intent-to-Treat (ITT)||Months||Full Range|Median
176671|NCT00050778|Secondary|Percent Change From Baseline in MRI T2 Lesion Volume at Year 3|Percent change in lesion volume at Year 3 was calculated from MRI-T2-weighted scans as: 100*([lesion volume at Year 3] minus [lesion volume at Baseline]) divided by [lesion volume at Baseline]).|Baseline, Year 3|Analysis population included participants in the FAS population (randomized with a correct diagnosis of MS) who had an evaluable scan for MRI-T2 lesion volume at Baseline and Year 3.||percent change||Standard Deviation|Mean
176672|NCT00050778|Secondary|Percent Change From Baseline in T1 Cerebral Volume at Year 3|Magnetic resonance imaging (MRI) T1 was used to determine rate of cerebral atrophy (decrease in cerebral/brain volume). Partial brain volumes were measured using the technique of Losseff et al. (1996). Percent change in cerebral volume at Year 3 was calculated from MRI-T1-weighted scans as: 100*([brain volume at Year 3] minus [brain volume at Baseline]) divided by [brain volume at Baseline]).|Baseline, Year 3|Analysis population included participants in the FAS population (randomized with a correct diagnosis of MS) who had an evaluable scan for MRI-T1 brain volume at Baseline and Year 3.||percent change||Standard Deviation|Mean
176673|NCT00050778|Secondary|Probability of Participants Who Were Relapse Free at 3 Years After Initial Treatment|Participants were considered relapse free at Year 3 if they did not experience a relapse between randomization and study completion at 36 months. Participants who discontinued early were considered relapse free if they did not experience a relapse prior to discontinuation. Probability of participants who were relapse free at Year 3, estimated using the KM method, was reported.|Year 3|FAS population included all randomized participants who had correct diagnosis of MS at entry.||probability of participants||95% Confidence Interval|Number
176674|NCT00050778|Primary|Annualized Relapse Rate|Relapse was defined as new neurological symptoms or worsening of previous neurological symptoms with an objective change on neurological examination, attributable to multiple sclerosis that lasted for at least 48 hours, that were present at normal body temperature, and that were preceded by at least 30 days of clinical stability. Annualized relapse rate was estimated using a Poisson regression model with observed number of relapses as a dependent variable, the log total amount of follow-up from date of randomization for each participant as an offset variable and treatment group indicator as a covariate.|Up to 3 years|FAS population included all randomized participants who had correct diagnosis of MS at entry.||relapses per participant per year||95% Confidence Interval|Number
176675|NCT00050778|Primary|Probability of Participants With Sustained Accumulation of Disability (SAD)|EDSS is an ordinal scale in half-point increments that quantifies disability in participants with MS. It assesses 7 functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral) as well as ambulation. EDSS total score: 0 (normal neurological examination) to 10 (death due to MS). As measured by EDSS score, SAD was defined as increase of at least 1.5 points for participants with Baseline score of 0 and increase of at least 1.0 point for participants with Baseline score of 1.0 or more; and the increase persisted for at least next the 2 scheduled assessments, that is, 6 consecutive months. The onset date of SAD was date of first EDSS assessment that began 6 month consecutive period of SAD. Participants who did not reach SAD endpoint were censored at their last visit. Probability of participants with SAD, estimated by Kaplan-Meier (KM) method, was reported.|Up to 3 years|Full Analysis Set (FAS) population included all randomized participants who had correct diagnosis of MS at entry.||probability of participants with SAD||95% Confidence Interval|Number
176676|NCT00050622|Secondary|Treatment Satisfaction|Parent rating of treatment satisfaction with medication, behavioral treatment, and their combination,on a scale of 1 (bad) to 7 (good).|End of Treatment|||Units on scale||Standard Deviation|Mean
176678|NCT00050622|Primary|Social Behavior-Negative Verbalizations|Sum of daily frequency of Verbal Abuse toward staff members, Teasing toward peers, and Cursing/Swearing as defined by a behavioral point system that doubles as an objective measure of children's behavior. All instances of these behaviors were reported and noted as they occur throughout daily activities.|Daily for 45 days|||Number of Observed Behaviors||Standard Deviation|Mean
176679|NCT00050089|Secondary|Number of Participants With New, Non-HIV Related Serious Adverse Event|New, on-study non-HIV related Serious Adverse events were compared between ARDFP (interruption) and No ARDFP (continuation)|From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|||participants|||Number
176680|NCT00050089|Secondary|Number of Participants With a New, Non-HIV Related Serious Adverse Event|New, on-study non-HIV related Serious Adverse events were compared between Standard-ART (standard) and Mega-ART (intensification)|From date of randomization until onset of secondary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|||participants|||Number
176681|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between No ARDFP (continuation)+Standard-ART (standard), No ARDFP (continuation)+Mega-ART (intensification), ARDFP (interruption)+Standard-ART (standard) and ARDFP (interruption)+Mega-ART (intensification)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to one of the four interventions (339 via the 2X2 factorial design)||participants|||Number
176682|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between No ARDFP (continuation) and ARDFP (interruption)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to No ARDFP or ARDFP (339 via the 2X2 factorial design and 0 via the UK Option Scheme)||participants|||Number
176683|NCT00050089|Primary|Number of Participants With New or Recurrent AIDS Event, or Death|New or recurrent AIDS event or Death were compared between Standard-ART (standard) and Mega-ART (intensification)|From date of randomization until onset of primary outcome or end of study follow-up (12/31/2007) whichever occured first, up to 6.5 years|This includes participants randomized to Standard-ART or Mega-ART (339 via the 2X2 factorial design and 29 via the UK Option Scheme)||participants|||Number
176684|NCT00050011|Secondary|Rate of Change From Baseline in Total Hip BMD|The rate of change from baseline in BMD was assessed.|Baseline, 5 years|ITT population||g/sq. cm/month||95% Confidence Interval|Mean
176685|NCT00050011|Secondary|Rate of Change From Baseline in Lumbar Spine (L1-L4) BMD|The rate of change from baseline in BMD was assessed.|Baseline, 5 years|ITT population||g/sq cm/month||95% Confidence Interval|Mean
176686|NCT00050011|Secondary|Time to Disease Recurrence/Relapse|The median time to disease progression was assessed by Kaplan-Meier analysis. The Principal Investigator assessed each participant for disease recurrence at each visit. Further testing was performed at the discretion of the Principal Investigator and as clinically indicated. Disease progression was defined as chest wall and/or regional recurrence confirmed by positive cytology or biopsy, and/or distance recurrence of the 1) skin, subcutaneous tissue, and lymph nodes (other than local or regional), 2) bone marrow, 3) lung, 4) skeleton 5) liver and 6) central nervous system confirmed by positive cytology, biopsy, aspirate or radiology as appropriate.|over 5 years|ITT population||months||95% Confidence Interval|Median
176687|NCT00050011|Secondary|Incidence Rate of All Clinical Fractures|The number of participants who experienced a clinical fracture at month 36 was assessed. Initial x-ray (both AP and lateral views) of the lumbar and thoracic spine were performed at baseline to exclude participants with evidence of fracture. In addition, repeated bone scan and/or x-ray were performed at the Principal Investigator's discretion during the course of the study to confirm evidence of clinical fracture, or at month 36 if there was no evidence of clinical fracture (lumbar and thoracic spine - lateral view). X-ray films were sent to a central reader.|3 years|ITT population||Participants|||Number
176688|NCT00050011|Secondary|Percent Change From Baseline in Biochemical Markers of Bone Turnover, Serum N-Telopeptide (sNTX) and Bone-specific Alkaline Phosphatase (BSAP)|Blood samples from a subset of participants (231 participants in total) were collected to measure the sNTX and BSAP. Missing data at month 12 were imputed by using the LOCF method. Post-baseline non-missing data from months 6 and 9 were carried forward to month 12. Data prior to month 6 were not carried forward. Missing data beyond month 12 were not imputed by LOCF.|Baseline, 12 months, 2 years, 3 years, 5 years|ITT population||Percentage of biochemical markers||Standard Deviation|Mean
176689|NCT00050011|Secondary|Percent Change From Baseline in Total Hip BMD|"Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader.~Percent change = 100*((BMD at Time Frame - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the LOCF method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward."|Baseline, 12 months, 2 years, 3 years, 5 years|ITT population||Percentage of BMD||Standard Deviation|Mean
176690|NCT00050011|Secondary|Percent Change From Baseline in Lumbar Spine (L1-L4) BMD|"Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader.~Percent change = 100*((BMD at Time Frame - Baseline BMD)/Baseline BMD)). Missing data beyond month 12 were not imputed by LOCF."|Baseline, 2 years, 3 years, 5 years|ITT population||Percentage of BMD||Standard Deviation|Mean
176691|NCT00050011|Primary|Percent Change From Baseline in Lumbar Spine (L1-L4) Bone Mineral Density (BMD)|Bone mineral density (BMD) measurements were assessed by dual energy x-ray absorptiometry (DXA). The DXA devices of participating sites were cross-calibrated and the DXA results were compiled and analyzed by a central reader. Percent change = 100*((BMD at Month 12 - Baseline BMD)/Baseline BMD)). Missing data at month 12 were imputed by using the last observation carried forward (LOCF) method. Post-baseline non-missing data from month 6 were carried forward to month 12. Data prior to month 6 were not carried forward.|Baseline, 12 months|Intent to treat (ITT population) was used. The ITT population contained all patients in the safety population for whom at least one post-baseline efficacy measurement was collected.||Percentage of BMD||Standard Deviation|Mean
176692|NCT00049842|Secondary|Number of Participants With no Worsening (ie, the Response Status of Improved/ no Change) in the METAVIR Activity Score During the Treatment.|"Definitions:~Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).~Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.||Participants|||Number
176693|NCT00049842|Secondary|Mean Change in the METAVIR Activity Score (Using a Continuous Scale)|"The change of Metavir Activity Score = Metavir Activity Score at up to Month-36 - Metavir Activity Score at Baseline.~Activity Scoring: 0 (no histological activity), 1 (minimal activity), 2 (moderate activity), 3 (severe activity), 4 (lobular chronic hepatitis)."|Baseline to up to Month-36|ITT population who had both pre and up to Month-36 METAVIR activity score.||Units on a scale||Standard Deviation|Mean
176694|NCT00049842|Secondary|The Number of Participants Whose METAVIR Fibrosis Score Did Not Worsen (ie, the Response Status of Improved/no Change) During Treatment Compared to Baseline|"Definitions:~Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).~Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.||Participants|||Number
176695|NCT00049842|Secondary|Mean Change From Baseline to up to Month-36 in the METAVIR Fibrosis Score (Using a Continuous Scale)|"The change of Metavir Fibrosis Score = Metavir Fibrosis Score at up to Month-36 - Metavir Fibrosis Score at Baseline.~Fibrosis scoring: 0 (no fibrosis), 1 (stellate enlargement of portal tract without septa formation, 2 (enlargement of portal tract with rare septa formation, 3 (numerous septa without cirrhosis), 4 (cirrhosis)."|Baseline to up to Month-36|ITT population who had both pre and up to Month-36 METAVIR fibrosis score.||Units on a scale||Standard Deviation|Mean
176696|NCT00049842|Secondary|Inflammation Response Status (ie, Improvement, no Change, or the Worsening of the METAVIR Activity Score as Compared to Baseline)|"Activity Scoring: A0 (no histological activity), A1 (minimal activity), A2 (moderate activity), A3 (severe activity), A4 (lobular chronic hepatitis).~Changes in liver inflammation defined as follows:~Improved: Participants whose METAVIR activity score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR activity score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR activity score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is ITT. Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.||Participants|||Number
176697|NCT00049842|Primary|Fibrosis Response Status (ie, Improvement, no Change, or the Worsening of the Fibrosis Score in Participants With Baseline METAVIR Fibrosis Score of F2 or F3).|"Definitions:~Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis).~Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline.~No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score.~Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline."|Baseline to up to Month-36|Population is Intent-to-Treat (ITT). Participants with missing Month-36 biopsy slides were classified as “no change”, including 88 participants in the PEG-Intron group and 104 participants in the Observed group.||Participants|||Number
176698|NCT00049543|Secondary|Incidence of Toxicities Graded Using the NCI Common Terminology Criteria for Adverse Events Version 3.0|The incidence of toxicities will be summarized by type of adverse event and severity. A Fisher’s exact test will be used to compare toxicities between the two arms.|Up to 5 years|All patients who received at least 1 dose of the treatment||participants|||Number
176699|NCT00049543|Secondary|Disease Free Survival|The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the disease free survival between two arms adjusting for the stratification factors. Five years disease free survival rate will be reported.|From randomization to the time of documented recurrence of the primary cancer, assessed up to 5 years|ITT population||percentage of 5-year disease free rate||95% Confidence Interval|Number
176700|NCT00049543|Primary|Overall Survival|The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the overall survival between two arms adjusting for the stratification factors. An unadjusted analysis will also be performed. Five years survival rate will be reported.|From randomization to the time of death from any cause, assessed up to 5 years|ITT population||percentage of 5 years survival rate||95% Confidence Interval|Number
176701|NCT00049530|Secondary|Overall Survival|Overall survival (OS) time was defined as the time from registration to death from any cause, or censored at last known date of survival.|assessed every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated||months||95% Confidence Interval|Median
176702|NCT00049530|Secondary|Progression Free Survival|Progression free survival (PFS) was defined as the time from registration to disease progression, or censored at last known date of non progressive disease.|assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated patients||months||95% Confidence Interval|Median
177266|NCT00039130|Secondary|2 Year Event Free Survival|Percentage of patients who were event free at 2 years. The 2-year event free rate was estimated using the Kaplan Meier method. An event is defined as death, progression or treatment failure.|2 years|||percentage of participants||95% Confidence Interval|Number
176703|NCT00049530|Secondary|Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)|"Objective tumor response was assessed using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions. Stable disease (SD) = did not meet criteria for response or progression.~Non-progression rate = CR + PR + SD."|assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years|eligible and treated patients||percentage of participants||95% Confidence Interval|Number
176704|NCT00049530|Primary|Plasma b-FGF Level Response|The primary endpoint was the suppression of plasma b-FGF level with low dose peginterferon alfa-2b. A clinically important reduction of plasma b-FGF levels was determined to be a level less than or equal to 7.5 pg/mL. A patient was considered to have a suppressed plasma b-FGF level, if the patient experienced the clinically significant reduction (less than or equal to 7.5 pg/mL) of plasma b-FGF levels for two consecutive determinations which were at least three weeks apart. This was considered as a b-FGF response.|assessed every 3 weeks until the suppression of plasma b-FGF level to normal, then every 6 weeks until the completion of 12 months of treatment, and upon treatment discontinuation|eligible and treated patients||percentage of participants||95% Confidence Interval|Number
176705|NCT00049517|Secondary|Overall Survival (Consolidation Phase)|Overall survival is defined as the time from randomization in the consolidation phase to death.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.|Only 270 patients who were randomized in the consolidation phase are included in the analysis.||Months||95% Confidence Interval|Median
176706|NCT00049517|Primary|Disease-free Survival (Consolidation Phase)|Disease-free survival is defined from the time of the confirmation of a complete remission via biopsy to the relapse of the disease.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until five years after study entry, and every 12 months thereafter.|Only 270 patients who were randomized in the consolidation phase are included in the analysis.||Months||95% Confidence Interval|Median
176707|NCT00049517|Primary|Overall Survival (Induction Phase)|Overall survival is defined as the time from randomization in the induction phase to death.|Assessed during the first 4 months, then at least every three months for 2 years. then every six months until 5 years after study entry and every 12 months thereafter.|All randomized patients are included in the analysis (intention-to-treat).||months||95% Confidence Interval|Median
176708|NCT00049322|Secondary|Measure (Vascular Endothelial Growth Factor)VEGF Before and After TACE With and Without Bevacizumab||21 days after TACE|||fold change|||Number
176709|NCT00049322|Secondary|Assess Pharmakokinetics of Bevacizumab in Liver Disease|bevacizumab serum concentrations|day 85|||micrograms/mL||95% Confidence Interval|Mean
176710|NCT00049322|Secondary|Assess the Toxicities of Bevacizumab in Patients With Liver Function Impairment||16 weeks|subjects that completed all 16 weeks.||participants|||Number
176711|NCT00049322|Secondary|Progression Free Survival|Progression free survival (PFS) at 16 weeks (end of the core phase).|16 weeks|Arm I: Patients receive bevacizumab Arm II. Patients do not receive bevacizumab.||probablility of pfs at 16 weeks|||Number
176712|NCT00049322|Primary|Neovessel Formation as Measured by Angiogram at 14 Weeks|Angiograms were assessed for changes in vascularity. The numbers indicate how many subjects in each group showed neovessel formation.|14 weeks|||participants|||Number
176713|NCT00049257|Secondary|Overall Survival Rate|Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of <50% and lesions with an estimated increase of <25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be >=25% or appearance of new lesions. Need for radiotherapy is considered PD.|Assessed every two months after completion of study treatment for 4 years|||participants|||Number
176714|NCT00049257|Secondary|Objective Response Rate|Complete response:Complete disappearance of all clinically detectable malignant disease for at least 4 weeks.Partial Response:Definite improvement in evaluable disease estimated to be in excess of 50% and agreed upon by 2 investigators. Response must last for at least 4 weeks.Stable disease:No significant change in disease for at least 4 weeks. Includes an estimated decrease of <50% and lesions with an estimated increase of <25%.Progressive disease(PD):Definite increase in area of any malignant lesion estimated to be >=25% or appearance of new lesions. Need for radiotherapy is considered PD.|Evaluated every 12 weeks during Treatment Period|||participants|||Number
176715|NCT00049257|Primary|Time to PSA Progression|In patients whose PSA has not decreased, progressive disease is a 25% increase over the baseline value and an increase in the absolute value PSA level by >=5ng/ml, confirmed by a second value at >=4 week intervals. In patients whose PSA has decreased but has not reached response criteria, progressive disease is defined as an increase in PSA by 25% over the nadir, provided that the increase is >=5ng/ml and is confirmed by a second value at >=4 week intervals.|Evaluated every 28 days during Treatment Period|||days||Full Range|Median
176716|NCT00049257|Primary|Prostate-specific Antigen (PSA) Response Rate|PSA response is defined as a decline from the baseline value of >=50% confirmed by a second PSA value 4 or more weeks later.|Evaluated every 28 days during Treatment Period. Number of completed cycles among 58 treated patients range from 1 to 24 cycles with a median of 4.5 cycles. one cycle = 28 days.|||participants|||Number
176717|NCT00049127|Secondary|Overall Time to Death|Kaplan-Meier survival curves and logrank tests will be used to estimate survival distributions.|Time from date of registration to date of death due to any cause or last follow-up, assessed up to 5 years|||months||95% Confidence Interval|Median
177267|NCT00039130|Primary|Complete Response Rate|Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.|6 months|||percentage of participants||95% Confidence Interval|Number
176718|NCT00049127|Secondary|Percentage of Patients Progression-free|"The percentage of patient progression-free at 12 months, 18 months, and PFS will be estimated. Kaplan-Meier survival curves and logrank tests will be used to estimate progression-time distributions.~Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|Time from study registration to date of disease progression or last follow-up, assessed up to 5 years|||months||95% Confidence Interval|Mean
176719|NCT00049127|Secondary|Confirmed Response (i.e., an Objective Status of Complete Response (CR), Partial Response (PR), or Regression (REGR) on 2 Successive Evaluations at Least 4 Weeks Apart After the Start of Study Treatment).|"Complete Response (CR) is defined using response criteria (the neurologic examination and the Magnetic resonance imaging (MRI) and/or Computerized Tomography (CT)), total disappearance of all tumor with patient off corticosteroids or only on adrenal replacement maintenance.~Partial Response (PR) is defined using response criteria (the neurologic examination and the MRI and/or CT), >=50% reduction in product of perpendicular diameters of contrast enhancement or mass with no new lesions with the patient being on stable or decreased steroid dose.~Regression (REGR) is defined using response criteria (the neurologic examination and the MRI and/or CT), unequivocal reduction in size of contrast-enhancement or decrease in mass effect as agreed upon independently by primary physician and quality control physicians; no new lesions. Patient should be on stable or decreased steroid dose."|Up to 5 years|||percentage of confirmed responses|||Number
176720|NCT00049127|Primary|6-month Progression-free Survival (PFS), Defined as a Patient Being Alive and Progression-free 183 Days After the Date of Registration.|"The proportion of successes will be estimated using the Binomial point estimator (number of successes divided by the total number of evaluable patients) and the Binomial 90% confidence interval estimated using the Duffy-Santer algorithm.~Progression is defined using response criteria (the neurologic examination and the MRI and/or CT), >25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions."|6 months|||percentage of patients|||Number
176721|NCT00049036|Primary|Complete Response Proportion as Measured by Tumor Response After Completion of Study Treatment|Complete response defined by the International Response Criteria for Non-Hodgkin's Lymphoma|60 days|ITT||proportion|||Number
176722|NCT00048997|Secondary|Impact of PCI on Incidence of CNS Metastases||After all patients have been potentially followed for a minimum of 12 months||||||
176723|NCT00048997|Secondary|Impact of PCI on Quality of Life||After all patients have been potentially followed for a minimum of 12 months||||||
176724|NCT00048997|Secondary|Neuropsychological Impact of Prophylactic Cranial Irradiation (PCI)||After all patients have been potentially followed for a minimum of 12 months||||||
176725|NCT00048997|Primary|Overall Survival|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months.|After all patients have been potentially followed for a minimum of 12 months|All eligible patients||months||95% Confidence Interval|Median
176726|NCT00048932|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by ELISA|Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337|All DB participants treated on study who received at least 1 dose of abatacept and had antibody samples collected at baseline and at least 1 post-baseline visit. 68 participants were not evaluated for anti-abatacept anti-bodies on study.||participants|||Number
176727|NCT00048932|Primary|OL; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities|Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Days 365 to Day 1821|All Treated Population.||participants|||Number
176728|NCT00048932|Primary|OL; Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting Marked Abnormality Criteria|MA criteria: serum glucose (Glu): <65 mg/dL/>220 mg/dL;fasting serum Glu: <0.8* LLN/>1.5*ULN,or if BL<LLN then use 0.8*BL or >ULN,or if BL>ULN then use >2.0*BL or <LLN;total protein: <0.9*LLN/>1.1*ULN,or if BL<LLN then use <0.9*BL or >UNL,or if BL>UNL then use >1.1*BL or <LLN; albumin: <0.9*LLN,or if BL<LLN then use <0.75 BL;uric acid: >1.5*ULN,or if BL>ULN then use >2*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells [RBCs], White Blood Cells [WBCs]):Use ≥2 when BL value missing or when pre-dose=0 or 0.5; use ≥3 when pre-dose=1, use ≥4 when pre-dose=2 or 3|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. N=Number of Participants Analyzed, n=number of participants with measurements at time point||participants|||Number
176729|NCT00048932|Primary|OL; Number of Participants With Electrolyte Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Sodium (Na): <0.95*LLN/ >1.05*ULN, or if BL<LLN then use <0.95* BL or >ULN, or if BL>ULN then use>1.05* BL or <LLN; potassium (K): <0.9* LLN/>1.1*ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; (Cl): <0.9* LLN/>1.1* ULN, or if BL<LLN then use <0.9* BL or >ULN, or if BL>ULN then use>1.1* BL or <LLN; calcium (Ca): <0.8* LLN/>1.2* ULN, or if BL<LLN then use <0.75* BL or >ULN, or if BL>ULN then use>1.25* BL or <LLN; phosphorous (P): <0.75* LLN/ >1.25* ULN, or if BL<LLN then use 0.67* BL or >ULN, or if BL>ULN then use>1.33* BL or <LLN|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant was not evaluated for electrolyte abnormalities.||participants|||Number
176730|NCT00048932|Primary|OL; Number of Participants With Liver Function Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant was not evaluated for liver function abnormalities.||participants|||Number
176731|NCT00048932|Primary|OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 1821, and including data up to 56 days post last dose of double-blind medication|All Treated Population.||participants|||Number
176732|NCT00048932|Primary|OL; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day 365 to Day 1821|All Treated Participants, all participants who received at least 1 dose of study medication||participants|||Number
176733|NCT00048932|Primary|Open Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug|Day 365 to Day 1,821|All Treated Participants||participants|||Number
176734|NCT00048932|Primary|DB; Number of Participants With Clinically Significant Physical Examination or Vital Signs Abnormalities|Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Vital sign measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically significant by the investigator.|Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337. Vital signs were measured at these visits before and after study medication infusion.|All Treated Population.||participants|||Number
176735|NCT00048932|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|Days 1, 29, 57, 85, 113,169, 281, 365|All participants treated during DB who received at least 1 dose of abatacept and had antibody samples collected at baseline and at least 1 post-baseline visit. 561 participants were not evaluated for anti-abatacept anti-bodies during the DB.||participants|||Number
176736|NCT00048932|Primary|DB; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality (MA) Criteria|ULN=upper level of normal; BL=baseline.Marked abnormality criteria: High alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; high aspartate aminotransferase (AST): >3* ULN (80 U/L), or if BL>ULN then use >4* BL; high alanine aminotransferase (ALT): >3* ULN (34-47 U/L), or if BL>ULN then use >4* BL; high G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; high bilirubin: >2* ULN, or if BL>ULN then use >4* BL; high blood urea nitrogen (BUN): >2* BL; high creatinine: >1.5* BL (ULN 14.6 pg/mg. AST ULN=80 U/L; ALT ULN=34-47 U/L;creatinine ULN=14.6 pg/mg.|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Population. Two participants in the ABA group and 3 participants in the PLA group were not evaluated for blood chemistry abnormalities due to data unavailability (missing data).||participants|||Number
176737|NCT00048932|Primary|DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Population. One participant in each group was not evaluated for hematology abnormalities due to data unavailability (missing data).||participants|||Number
176738|NCT00048932|Primary|DB; Number of Participants With AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Participants, all participants who received at least 1 dose of study medication||participants|||Number
176750|NCT00048724|Primary|Time to Observation of the First Clinical Event Experienced by a Subject|Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation|Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event|Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses.||Participants|||Number
176739|NCT00048932|Primary|Double Blind Period (DB); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related SAE/AE = possibly, probably, or certainly related to study drug|Day 1 to Day 365, and including data up to 56 days post last dose of double-blind medication|All Treated Participants, all participants who received at least 1 dose of study medication||participants|||Number
176740|NCT00048893|Secondary|Number of Participants With a Clinical Response|Defined as measurable disease (any solid lesion that can be measured accurately in at least one dimension), evaluable disease (disease not readily measurable but can be clinically assessed), complete response (complete disappearance of all measurable and evaluable disease), partial response (decrease of greater than or equal to 50%), stable disease (any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions), or progressive disease (greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease).|At the beginning of each cycle of chemotherapy (every 4 weeks)|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||Participants|||Number
176741|NCT00048893|Secondary|Number of Participants With an Immune Response as a Result of the Salvage Immunization Schedule|Patients showing disease progression or recurrence at any point after the start of the early immunizations series may continue on study in accordance to the off study criteria and will be receiving monthly rF immunizations for a total of 12 months or until further disease progression meets the off study criteria. Immune response as evidenced by change in lymphocyte subsets in the blood.|6 weeks, than 6, 12, 18, 24, 30, 36 (3y), 42, 48 (4y), 60 and 72 months after completion of immune chemotherapy|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||Participants|||Number
176742|NCT00048893|Secondary|Number of Months of Progression Free Survival|The time period a participant remains free from progressive disease. Progressive disease (PD) is defined as a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease or the appearance of new disease or an increase in evaluable disease.|After the immune depletion cycle|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||Months|||Number
176743|NCT00048893|Secondary|Immune Response to the Vaccine in Those Patients With Late Recovery of Thymic Function|It is expected that delayed administration of a vaccine will result in enhancement of immune response to the vaccine in those patients with later recovery of thymic function as evidenced by change in lymphocyte subsets in the blood.|2 years|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||Cells/L|||Number
176744|NCT00048893|Secondary|Log Change of CD4 CEA-specific Immune Responses and Their Kinetics as a Surrogate Marker for Clinical Anti-tumor Activity of the Vaccines|Response is evaluated by CD4 response to CEA soluble protein. The log change in precursor frequencies will be calculated between values obtained at baseline and five months post immune depletion. By flow cytometry of peripheral blood lymphocyte frequency of potential killer cells directed to the CEA protein.|Baseline and 5 months post immune depletion|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||log change of CD4 CEA specific precursor|||Number
176745|NCT00048893|Secondary|Log Change in Precursor Frequency as Measured by Elispot.|The log change in CEA-specific T cell precursor frequency will be calculated between values obtained at baseline and 5 months post immune depletion. A change equal to 1.0 standard deviation (SD) of the log change is significant.|time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||log change in CEA-specific T cell precur|||Number
176746|NCT00048893|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|91 months|||Participants|||Number
176747|NCT00048893|Primary|Event-free Survival as Measured by Clinical Evaluation and Tumor Measurements by Imaging|Complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is a decrease of greater than or equal to 50% in the sum of the products of the longest perpendicular dimensions of all measurable target lesions. Stable disease (SD) is any decrease of less than 50% or increase less than 25% in the sum of the longest perpendicular dimensions of measurable disease. Progressive disease (PD) is a greater than 25% increase in the sum of the longest perpendicular dimensions of any measurable disease.|time to progression, response rate: evaluation every 3 months for 3 years, then every 6 months for one year (fourth year), then yearly thereafter until taken off study|The study was closed to accrual due to very poor enrollment. No meaningful data analysis was possible on the small number of accrued subjects, so none was done.||Months|||Number
176748|NCT00048737|Primary|Number of Participants With Graft Failure|Graft failure is defined as either lack of hematologic recovery or lack of or loss of detectable donor cells.|100 days|||participants|||Number
176749|NCT00048724|Secondary|Time to Observation of the Disease Progression Experienced by a Subject|Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy.|Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event|Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses.||Participants|||Number
176751|NCT00048581|Secondary|Cumulative Analysis (DB + OL); Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbent Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|From BL (Day 1) to Day 1821|All participants treated on study with at least one post-baseline immunogenicity measurement.||participants|||Number
176752|NCT00048581|Secondary|OL; Mean Change From Baseline in Activity Limitation Score Over Time For Participants Treated in the OL|Limitations on activities of daily living in the OL period at each study visit was measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.|Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176753|NCT00048581|Secondary|OL; Mean Time-matched Baseline Activity Limitation Score Over Time For Participants Treated in the OL|Limitations on activities of daily living in the OL period at each study visit were measured by a 2-item questionnaire that was developed to collect data on the amount of time that a participant is unable to perform their usual activities because of their rheumatoid arthritis. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit. The scale ranges from 0 to 100 with increasing score indicating increasing restrictions on levels of activity.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176754|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Fatigue VAS Over Time For Participants Treated in the OL|Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.||units on a scale||Standard Error|Mean
176755|NCT00048581|Secondary|OL; Mean Time-matched Baseline Fatigue Visual Analog Score (VAS) Over Time For Participants Treated in the OL|Fatigue severity was assessed on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176756|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in MOS-Sleep Score Over Time For Participants Treated in the OL|The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100 with a higher score reflecting more severe problems with sleep. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.||units on a scale||Standard Error|Mean
176757|NCT00048581|Secondary|OL; Mean Time-matched Baseline Medical Outcomes Study Sleep Module (MOS-sleep) Score Over Time For Participants Treated in the OL|The validated 12-it3em Medical Outcomes Study sleep questionnaire (MOS-sleep) was used to measure sleep quality. An overall Sleep Problem Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100 with a higher score reflecting more severe problems with sleep. The mean score of the SPI in a population with chronic problems is 29.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176758|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Mental Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
177180|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 36|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Inter-Quartile Range|Median
176759|NCT00048581|Secondary|OL; Mean Time-matched Baseline Mental Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176760|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Role-Emotional Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176761|NCT00048581|Secondary|OL; Mean Time-matched Baseline Role-Emotional Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176762|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Social Functioning Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176763|NCT00048581|Secondary|OL; Mean Time-matched Baseline Social Functioning Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176764|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Vitality Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176778|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in ESR Over Time For Participants Treated in the OL|ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||mm/hr||Standard Error|Mean
176765|NCT00048581|Secondary|OL; Mean Time-matched Baseline Vitality Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176766|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in General Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176767|NCT00048581|Secondary|OL; Mean Time-matched Baseline General Health Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176768|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Bodily Pain Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176769|NCT00048581|Secondary|OL; Mean Time-matched Baseline Bodily Pain Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176770|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Role-Physical Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176779|NCT00048581|Secondary|OL; Mean Time-matched Baseline Erythrocyte Sedimentation Rate (ESR) Over Time For Participants Treated in the OL|ESR, also called a sedimentation rate or Biernacki Reaction, is the rate at which red blood cells sediment in a period of 1 hour. It is a common hematology test that is a non-specific measure of inflammation. Time-matched baseline levels of ESR were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||mm/hr||Standard Deviation|Mean
176771|NCT00048581|Secondary|OL; Mean Time-matched Baseline Role-Physical Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176772|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Physical Function Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176773|NCT00048581|Secondary|OL; Mean Time-matched Baseline Physical Function Score Over Time For Participants Treated in the OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176774|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in SF-36 PCS and MCS Over Time For Participants Treated in OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176775|NCT00048581|Secondary|OL; Mean Time-matched Baseline SF-36 PCS and MCS Over Time For Participants Treated in OL|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores:PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176776|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of sIL-2R Over Time For Participants Treated in the OL|IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||pg/ml||Standard Error|Mean
176777|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of Soluble Interleukin 2 Receptor (sIL-2R) Over Time For Participants Treated in the OL|IL-2 is a proinflammatory cytokine, and the soluble form of its receptor (IL-2R) is a marker for inflammation. Time-matched baseline levels of IL-2R were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||pg/ml||Standard Deviation|Mean
176983|NCT00048542|Other Pre-specified|Baseline Measure: Gender, Female/Male - OLE BSA Phase|Gender (female/male) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.|Baseline OLE BSA Phase|||Participants|||Number
176780|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of CRP Over Time For Participants Treated in the OL|CRP is an acute phase reactant protein that is a clinical marker for RA. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||mg/dL||Standard Error|Mean
176781|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of C-Reactive Protein (CRP) Over Time For Participants Treated in the OL|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). Time-matched baseline levels of CRP were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||mg/dL||Standard Deviation|Mean
176782|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in Levels of RF Over Time For Participants Treated in the OL|RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 169, 365, 729, 1093, 1261, 1457, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||IU/ml||Standard Error|Mean
176783|NCT00048581|Secondary|OL; Mean Time-matched Baseline Levels of Rheumatoid Factor (RF) Over Time For Participants Treated in the OL|RF is an autoantibody most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. Time-matched baseline levels of RF were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||IU/ml||Standard Deviation|Mean
176784|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in HAQ-DI and HAQ Component Scores For Participants Treated in the OL|HAQ-DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains:dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at that visit|BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176785|NCT00048581|Secondary|OL; Mean Time-matched Baseline HAQ-DI and HAQ Component Scores Over Time For Participants Treated in the OL|The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176786|NCT00048581|Secondary|OL; Number of Participants Achieving HAQ Response Over Time In Participants Treated in the OL|The HAQ disability index (HAQ DI) is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants analyzed, n=number of participants with measurements at visit.||participants|||Number
176794|NCT00048581|Primary|OL; Mean Time-matched Baseline Immunoglobulin (Ig) Levels Over the OL|Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with serum samples available at that visit.|Baseline and Days 169, 365, 729, and 1093|All treated participants with available serum samples. N=the total number of participants analyzed, n=the number of participants at that time point with available serum samples. Mean time-matched baseline values reflect changing n-values over time.||mg/dL||Standard Deviation|Mean
176787|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in DAS28 (ESR) Over Time For Participants Treated in the OL|DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|BL, Days 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176788|NCT00048581|Secondary|OL; Mean Time-matched Baseline DAS28 (ESR) Over Time For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176789|NCT00048581|Secondary|OL; Mean Time-matched Change From Baseline in DAS28 (CRP) Over Time For Participants Treated in the OL|DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Error|Mean
176790|NCT00048581|Secondary|OL; Mean Time-matched Baseline DAS28 (CRP) Over Time For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Time-matched baseline values were presented by visit and represented the mean baseline value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176791|NCT00048581|Secondary|OL; Number of Participants With Low Disease Activity (LDAS) or Remission For Participants Treated in the OL|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||participants|||Number
176792|NCT00048581|Secondary|OL; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time For Participants Treated in the OL|ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.|Days 15, 29, 57, 85, 113, 141, 169, 253, 365, 449, 533, 617, 729, 813, 897, 981, 1093, 1261, 1457, 1625, and 1821|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||participants|||Number
176793|NCT00048581|Primary|OL; Mean Time-matched Change From Baseline in Immunoglobulin (Ig) Levels Over the OL|Serum samples collected from participants were used to determine serum levels of IgA, IgM, and IgG. Time-matched mean change from baseline = Post-baseline value - time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with serum samples available at that visit.|BL, Days 169, 365, 729, and 1093|All treated participants with available serum samples. N=the total number of participants analyzed, n=the number of participants at that time point with available serum samples. Mean time-matched baseline values reflect changing n-values over time.||mg/dL||Standard Error|Mean
177550|NCT00025233|Primary|Progression-free Survival Greater Than 6 Months|Whether or not the patient survived progression-free for at least 6 months.|Every other 3-week treatment cycle|Eligible and Treated Patients||percentage of participants||90% Confidence Interval|Number
176795|NCT00048581|Primary|OL; Number of Participants With Blood Chemistry Laboratories Meeting Marked Abnormality Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From first day of OL to 5.5 years|All treated participants||participants|||Number
176796|NCT00048581|Primary|OL; Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|From first day of OL to 5.5 years|All treated participants||participants|||Number
176797|NCT00048581|Primary|OL; Number of Participants AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From first day of OL to 5.5 years|All treated participants||participants|||Number
176798|NCT00048581|Secondary|DB; Number of Participants With Positive Anti-Abatacept or Anti-Cytotoxic T-Lymphocyte Antigen 4 (CTLA4) Responses by Enzyme-Linked Immunosorbant Assay (ELISA)|Serum samples from all treated adult participants with active rheumatoid arthritis (RA) were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.|From BL to Day 169|All treated participants in the double-blind period with at least 1 post-baseline immunogenicity result||participants|||Number
176799|NCT00048581|Primary|Open-Label Period (OL); Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From first day of OL to 5.5 years|All treated participants||participants|||Number
176800|NCT00048581|Secondary|DB; Number of Participants With Blood Chemistry Laboratories Meeting MA Criteria|Marked abnormality criteria: Alkaline phosphatase (ALP): >2* ULN, or if BL>ULN then use >3* BL; aspartate aminotransferase (AST): >3* ULN, or if BL>ULN then use >4* BL; alanine aminotransferase (ALT): >3* ULN, or if BL>ULN then use >4* BL; G-Glutamyl transferase (GGT): >2* ULN, or if BL>ULN then use >3* BL; Bilirubin: >2* ULN, or if BL>ULN then use >4* BL; blood urea nitrogen (BUN): >2* BL; creatinine: >1.5* BL|From BL up to database lock for DB period (6/2/2004)|All treated participants||participants|||Number
176801|NCT00048581|Secondary|DB; Number of Participants With Hematology Laboratories Meeting Marked Abnormality (MA) Criteria|Upper Normal Limit (ULN), Lower Normal Limit (LLN), Baseline (BL). Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use 0.5 * BL/<100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL/>ULN, or if BL>ULN then use >1.2 * BL/<LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|From BL up to database lock for DB period (6/2/2004)|All treated participants||participants|||Number
176802|NCT00048581|Secondary|DB; Number of Participants AEs of Special Interest|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs (pre-specified AEs occurring within 1 hour of start of infusion) and peri-infusional AEs (pre-specified AEs occurring within 24 hours of the start of infusion).|From BL up to database lock for DB period (6/2/2004)|All treated participants||participants|||Number
176803|NCT00048581|Secondary|DB; Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, SAEs Leading to Discontinuation, AEs, Related AEs, or AEs Leading to Discontinuation|AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.Related AE/SAE=Certain,Probable,Possible,or Missing relationship to Drug|From BL up to database lock for DB period (6/2/2004)|All treated participants||participants|||Number
176804|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in DAS28 (CRP) and DAS28 (ESR)|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Error|Mean
176805|NCT00048581|Secondary|DB; Mean Disease Activity Score (DAS)28 (C-Reactive Protein [CRP]) and Mean Disease Activity Score (Erythrocyte Sedimentation Rate [ESR]) at Day 169|The DAS28 is a continuous disease measure which is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, ESR or CRP levels, and participant assessment of disease activity measure on a visual analogue scale. The DAS28 has numeric thresholds that define high disease activity (> 5.1), low disease activity (< 3.2) and remission (< 2.6). A clinically significant response= decrease in DAS28 score of >1.2 from baseline. The mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with assessments available at that visit.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Deviation|Mean
176806|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169|HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI=weighted sum of the scale scores. Higher score indicates poorer function.Change from BL = Post-BL value – time-matched BL value, where the time-matched BL value represents the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||units on a scale||Standard Deviation|Mean
176807|NCT00048581|Secondary|DB; Mean Baseline HAQ-DI and HAQ Component Scores in Participants With Assessments at Day 169|The HAQ DI is a self-administered questionnaire composed of 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. HAQ-DI is a weighted sum of the scale scores, with a higher score indicating poorer function. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||units on a scale||Standard Deviation|Mean
176808|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 169 in SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value – time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Deviation|Mean
176809|NCT00048581|Secondary|DB; Mean Baseline SF-36 PCS, MCS, and SF-36 Individual Component Scores For Participants With Measurements at Day 169|SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 169 BL value for only that cohort of participants with data available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Deviation|Mean
176810|NCT00048581|Secondary|DB; Adjusted Mean Change From Baseline to Day 85 in Short SF-36 PCS, MCS, and SF-36 Individual Component Scores|SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score. Change from Baseline= Post-baseline value – time-matched baseline value, where time-matched BL value = the mean BL value for only that cohort of participants with data available at Day 85.|BL, Day 85|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Error|Mean
176826|NCT00048581|Secondary|DB; Mean Time-matched Baseline Participant Pain Assessment Over Time: ACR Core Component|The participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Pain Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176811|NCT00048581|Secondary|DB; Mean Baseline Short Form 36 (SF-36) Quality of Life Physical Component Summary (PCS), Mental Component Summary (MCS), and SF-36 Individual Component Scores For Participants With Measurements at Day 85|SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Mean BL value presented represents a time-matched Day 85 BL value for only that cohort of participants with data available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||Units on a Scale||Standard Deviation|Mean
176812|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Rheumatoid Factor (RF) Status|Rheumatoid factor (RF or RhF) is an autoantibody (antibody directed against an organism's own tissues) most relevant in rheumatoid arthritis. It is an antibody against the Fc portion of Immunoglobulin (Ig)G, which is itself an antibody. RF and IgG join to form immune complexes which contribute to the disease process. A positive value for RF was >20 IU/mL; a negative value for RF was ≤ 20 IU/mL.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||participants|||Number
176813|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (E-Selectin, sICAM-1, and MMP-3) in Participants With Measurements at Day 169|Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. Change from Baseline = Post-baseline value – time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||ng/ml||Standard Error|Mean
176814|NCT00048581|Secondary|DB; Mean Baseline Levels of Disease Biomarkers (E-Selectin, Soluble Inter-Cellular Adhesion Molecule 1 [sICAM-1], and Matrix Metalloproteinase-3 [MMP-3]) in Participants With Measurements at Day 169|Potential biomarkers of disease (E-selectin, sICAM-1, and MMP-3) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||ng/ml||Standard Deviation|Mean
176815|NCT00048581|Secondary|DB; Mean Change From Baseline to Day 169 in Levels of Disease Biomarkers (IL-6, sIL-2R, and TNF-alpha) in Participants With Measurements at Day 169|The mean change from baseline in levels of potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. Change from Baseline = Post-baseline value – time-matched baseline value, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at Day 169.|BL, Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||pg/ml||Standard Error|Mean
176816|NCT00048581|Secondary|DB; Mean Baseline Levels of Disease Biomarkers (Interleukin-6 (IL-6), Soluble IL-2 Receptor [sIL-2R], and Tumor Necrosing Factor [TNF]-Alpha) in Participants With Measurements at Day 169|Potential biomarkers of disease (IL-6, SIL-2R, and TNF-Alpha) were determined from serum samples for all participants. The mean baseline value presented represents a time-matched Day 169 baseline value for only that cohort of participants with assessments available at that visit.|BL|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||pg/ml||Standard Deviation|Mean
176817|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in CRP Levels Over Time: ACR Core Component|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels indicate increasing level of disease. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with data available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
176818|NCT00048581|Secondary|DB; Mean Time-matched Baseline C-Reactive Protein (CRP) Levels Over Time: ACR Core Component|CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA) and a core component of the ACR scoring system. CRP was evaluated from serum samples. Increasing levels of CRP indicate increasing level of disease. For each post-baseline visit in the DB, time-matched baseline CRP values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||mg/dL||Standard Deviation|Mean
176819|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Physician Global Assessment Over Time: ACR Core Component|Physician global rheumatoid arthritis (RA) assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
176820|NCT00048581|Secondary|DB; Mean Time-matched Baseline Physician Global Assessment Over Time: ACR Core Component|Physician global rheumatoid arthritis (RA) assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Physician Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176821|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Participant Global Assessment Over Time: ACR Core Component|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
176822|NCT00048581|Secondary|DB; Mean Time-matched Baseline Participant Global Assessment Over Time: ACR Core Component|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. For each post-baseline visit in the DB, time-matched baseline Participant Global Assessment values were presented and represent the mean baseline value for only that cohort of participants with assessments available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176823|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in HAQ-DI Over Time: ACR Core Component|A self-administered questionnaire with 20 questions assessing physical function in 8 domains:dressing,arising,eating,walking,hygiene,reach,grip and common activities.Questions evaluated on a 4-point scale:0=without any difficulty,1=with some difficulty,2=with much difficulty,and 3=unable to do. HAQ-DI=weighted sum of scale scores, with higher scores indicating poorer function. Mean time-matched % change from BL=(time-matched BL value - Post-BL value)/time-matched BL value x100, where time-matched BL value=the mean BL value for only that cohort of participants with data available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
176824|NCT00048581|Secondary|DB; Mean Time-matched Baseline HAQ-DI Over Time: ACR Core Component|HAQ-DI is a self-administered questionnaire composed of 20 questions assessing physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. Questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ-DI is the weighted sum of the scale scores, with higher scores indicating poorer function. For each post-BL visit, time-matched BL HAQ-DI values were presented and represent the mean BL value for only that cohort of participants with data available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||units on a scale||Standard Deviation|Mean
176825|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in Participant Pain Assessment Over Time: ACR Core Component|Participant self-reported pain assessment is a core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100 mm Visual Analog Scale (VAS) with 0 mm representing no pain and 100 mm representing the most pain possible. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with assessments available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with data. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
176827|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in SJC Over Time: ACR Core Component|The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicate increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
176828|NCT00048581|Secondary|DB; Mean Time-matched Baseline Swollen Joint Count (SJC) and Post-Baseline SJCs Over Time: ACR Core Component|The mean SJC core component of the ACR scoring system was evaluated based on the number of swollen joints in a standard 66 joint count, where an increasing number of swollen joints indicates increasing level of severity. Time-matched baseline SJC values for each post-baseline SJC in the DB were presented for each visit and represent the mean baseline SJC value for only that cohort of participants with SJCs available at that visit.|Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with SJCs. Mean time-matched BL values reflect changing n-values over time.||swollen joints||Standard Deviation|Mean
176829|NCT00048581|Secondary|DB; Mean Time-Matched Percentage of Change From Baseline in TJC Over Time: ACR Core Component|The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Mean Time-matched percentage of change from baseline = (time-matched baseline value - Post-baseline value)/time-matched baseline value x 100, where the time-matched baseline value represents the mean baseline value for only that cohort of participants with TJCs available at that visit.|BL, Days 15, 29, 57, 85, 113, 141, and 169|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with TJCs. Mean time-matched BL values reflect changing n-values over time.||percentage of change from BL||Standard Error|Mean
176830|NCT00048581|Secondary|DB; Mean Time-matched Baseline Tender Joint Counts (TJCs) and Post-Baseline TJCs Over Time: ACR Core Component|The mean TJC core component of the ACR scoring system was evaluated based on the number of tender joints in a standard 68 joint count, where an increasing number of tender joints indicates increasing level of severity. Time-matched baseline TJC values for each post-baseline TJC in the DB were presented for each visit and represent the mean baseline TJC value for only that cohort of participants with TJCs available at that visit.|BL|Intent-to-treat (ITT) population: all randomized subjects receiving at least 1 dose of study drug. 2 participants were unevaluable for response due to each missing 2 infusions of study drug. N=total number of participants analyzed, n=the number of participants at time point with TJCs. Mean time-matched BL values reflect changing n-values over time.||tender joints||Standard Deviation|Mean
176831|NCT00048581|Secondary|DB; Number of Participants With ACR 20, ACR 50, and ACR 70 Responses Over Time|ACR 20/50/70 response requires a participant to have a 20/50/70% reduction in the number of swollen and tender joints, and a reduction of 20/50/70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20/50/70 response if the participant had ACR 20/50/70 observed for at least 2 consecutive study visits.|Days 15, 29, 57, 85, 113, 141, and 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug. N=Number of Participants Analyzed, n=number of participants at visit||participants|||Number
176832|NCT00048581|Primary|DB; Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ)|The disability section of the full HAQ includes 20 questions to assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip and common activities. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1= with some difficulty, 2= with much difficulty, and 3= unable to do. Higher scores= greater dysfunction. A disability index was calculated by summing the worst scores in each domain and dividing by the number of domains answered. Clinically meaningful HAQ response=an improvement of at least 0.3 units from baseline in HAQ disability Index.|Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized subjects who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.||participants|||Number
176833|NCT00048581|Primary|Double-blind Period (DB); Number of Participants With American College of Rheumatology (ACR) 20 Response at Day 169|ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 169|Analysis was carried out on the intent-to-treat (ITT) population defined as all randomized participants who received at least one dose of study medication. Two participants were unevaluable for response due to each missing 2 infusions of study drug.||participants|||Number
176870|NCT00048568|Secondary|Mean Change From BL in RF in the DB Period|The mean change from baseline in participant rheumatoid factor was determined after 6 months and 1 year of treatment relative to baseline. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||IU / mL||Standard Error|Mean
176834|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 2,185 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176835|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 2,185 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176836|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,989 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,989|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176837|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,989 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,989|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176838|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,821 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176839|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,821 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176840|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,625 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,625|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176841|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,625 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,625|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176842|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,457 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176843|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,457 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176844|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,345 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,345|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176845|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,345 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,345|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176846|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,261 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,261|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176847|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,261 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,261|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176848|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,177 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,177|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176849|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,177 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,177|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176850|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 1,093 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,093|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176851|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 1,093 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 1,093|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176852|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 981 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 981|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis.||Units on a Scale||Standard Error|Mean
176853|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 981 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 981|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176854|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 897 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 897|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
177908|NCT00004054|Secondary|Disease Free Survival||From randomization to the first occurrence of biochemical failure, clinical failure (local or distant), death from any cause, or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.||||||
176855|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 897 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 897|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176856|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 813 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 813|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176857|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 813 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 813|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176858|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 729 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 729|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176859|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 729 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 729|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176860|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 617 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 617|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176861|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) of the Day 617 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 617|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176862|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 533 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 533|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176863|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 533 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 533|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176864|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 449 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 449|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176865|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 449 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 449|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176866|NCT00048568|Secondary|Mean Change From BL in HAQ-DI Score and HAQ-DI Individual Component Scores at Day 365 for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 365|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176867|NCT00048568|Secondary|Mean BL HAQ-DI Score and HAQ-DI Individual Component Scores at BL (Day 0) for the Day 365 Cohort of Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 365|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176868|NCT00048568|Secondary|Mean Change From BL in E-Selectin, SICAM-1, and MMP3 in the DB Period|The mean change from basline in particpant biomarkers of RA disease (E-Selectin, SICAM-1, and MMP3) after 6 months and 1 year of treatment, relative to baseline, were evaluated.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||ng / mL||Standard Error|Mean
176869|NCT00048568|Secondary|Mean BL E-Selectin, SICAM-1, and MMP3 in the DB Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||ng / mL||Standard Error|Mean
176871|NCT00048568|Secondary|Mean Change From BL in Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period|The mean change from baseline in potential biomarkers of disease (IL-6, SIL-3R, and TNF-Alpha were determined for all participants.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||pg / mL||Standard Error|Mean
176872|NCT00048568|Secondary|Mean BL Interleukin-6 (IL-6), SIL-2R, and Tumor Necrosis Alpha (TNF-Alpha) in the DB Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|All treated participants in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||pg / mL||Standard Deviation|Mean
176873|NCT00048568|Primary|Mean Change From BL in Serum Electrolytes in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||mEq/L||Standard Error|Mean
176874|NCT00048568|Primary|Mean BL Serum Electrolytes in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||mEq/L||Standard Deviation|Mean
176875|NCT00048568|Primary|Mean Change From BL in Select Laboratory Parameters in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg/dL||Standard Error|Mean
176876|NCT00048568|Primary|Mean BL Select Laboratory Parameters in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg/dL||Standard Deviation|Mean
176877|NCT00048568|Primary|Mean Change From BL in Liver Function Parameters in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||U/L||Standard Error|Mean
176878|NCT00048568|Primary|Mean BL Liver Function Parameters in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||U/L||Standard Deviation|Mean
176879|NCT00048568|Primary|Mean Change From BL in White Blood Cells in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||10^3 c/uL||Standard Error|Mean
176880|NCT00048568|Primary|Mean BL White Blood Cells in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||10^3 c/uL||Standard Deviation|Mean
176881|NCT00048568|Secondary|Mean Change From BL in Limitations on Activities of Daily Living in the OL Period|The mean change from baseline in limitations on activities of daily living in the OL period. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA.|BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Days||Standard Error|Mean
176882|NCT00048568|Secondary|Mean BL Limitations on Activities of Daily Living in the OL Period|Mean baseline values are reported for each cohort at each time point. Activity limitation was measured by the number of days in the past 30 days a participant was unable to perform usual activities due to RA. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Days||Standard Deviation|Mean
177181|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 24|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Inter-Quartile Range|Median
176883|NCT00048568|Secondary|Mean Change From BL in Sleep Quality in the OL Period|The mean change from baseline in sleep quality was assessed on the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176884|NCT00048568|Secondary|Mean BL Sleep Quality in the OL Period|Mean baseline values are reported for each cohort at each time point using the Medical Outcomes Study Sleep scale (MOS-sleep [assesses the extent of sleep problems and measures six dimensions of sleep on a 12-item participant-reported measure]). An overall Sleep Problems Index (SPI) was generated as a summary measure of different types of sleep problems (sleep disturbance, sleep quantity, sleep adequacy, etc.). The score ranges from 0 to 100, with 0 = no problems with sleep and 100 = the most severe problems with sleep. The mean score of the SPI in a population with chronic conditions is 29.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176885|NCT00048568|Secondary|Mean Change From BL in Fatigue in the OL Period|The mean change from baseline in fatigue was measured on the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176886|NCT00048568|Secondary|Mean BL Fatigue in the OL Period|Mean baseline values are reported for each cohort at each time point using the VAS 100 mm where 0= no fatigue to 100 = the worst fatigue imaginable. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176887|NCT00048568|Secondary|Mean Change From BL by Visit in the Mental Health Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176888|NCT00048568|Secondary|Mean BL Mental Health Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176889|NCT00048568|Secondary|Mean Change From BL by Visit in the Vitality Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176890|NCT00048568|Secondary|Mean BL Vitality Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176891|NCT00048568|Secondary|Mean Change From BL by Visit in the Role-Emotional Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176892|NCT00048568|Secondary|Mean BL Role-Emotional Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176893|NCT00048568|Secondary|Mean Change From BL by Visit in the Social Functioning Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176894|NCT00048568|Secondary|Mean BL Social Functioning Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176895|NCT00048568|Secondary|Mean Change From BL by Visit in the General Health Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176929|NCT00048568|Secondary|Mean Change From BL in ESR in the OL Period|Serum samples were evaluated from study participants to determine the mean change from baseline in ESR values.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||IU / mL||Standard Error|Mean
176896|NCT00048568|Secondary|Mean BL General Health Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176897|NCT00048568|Secondary|Mean Change From BL by Visit in the Bodily Pain Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176898|NCT00048568|Secondary|Mean BL Bodily Pain Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|AlAll treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176899|NCT00048568|Secondary|Mean Change From BL by Visit in the Role-Physical Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176900|NCT00048568|Secondary|Mean BL Role-Physical Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176901|NCT00048568|Secondary|Mean Change From BL by Visit in the Physical Function Component of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176930|NCT00048568|Secondary|Mean BL ESR and CRP Levels in the OL Period|Mean baseline values are reported for each cohort at each time point.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||IU / mL||Standard Deviation|Mean
176902|NCT00048568|Primary|Mean Change From BL in Hemoglobin, Total Protein, and Albumin in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||g/dL||Standard Error|Mean
176903|NCT00048568|Primary|Mean BL Hemoglobin, Total Protein, and Albumin in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||g/dL||Standard Deviation|Mean
176904|NCT00048568|Primary|Mean Change From BL in Participant Platelet Count in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||10^9 c/L||Standard Error|Mean
176905|NCT00048568|Primary|Mean BL Platelet Count in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.||10^9 c/L||Standard Deviation|Mean
176906|NCT00048568|Primary|Mean Change From BL in Participant Hematocrit in the OL Period|All changes in participant laboratory parameters were monitored on each day of study drug administration.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).N = number of participants analyzed and n = the number of participants with measurements for that time point.||Percentage Blood Volume Occupied by RBCs||Standard Error|Mean
176907|NCT00048568|Primary|Mean BL Hematocrit in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365 to Day 2,185.|Baseline (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 1,905, Day 1,989, Day 2,073, Day 2,185|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period). N = number of participants analyzed and n = the number of participants with measurements for that time point.||Percentage of Red Blood Cells||Standard Deviation|Mean
176908|NCT00048568|Primary|Number of Participants Experiencing AEs of Special Interest in the OL Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest have been identified to be those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
176909|NCT00048568|Primary|Number of Participants Experiencing Clinically Significant Changes in Vital Signs in the OL Period|Vital signs included body temperature, heart rate, and seated blood pressure. Clinically significant changes were defined as those that were not within the normal range for the participant.|Day 365 to Day 1,821. All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing.|All treated participants entering the OL period.||Participants|||Number
176910|NCT00048568|Secondary|Mean BL Physical Function Component of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176911|NCT00048568|Secondary|Mean Change From BL by Visit in the Mental Component Summary of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176920|NCT00048568|Secondary|Mean Change From BL in DAS-28 ESR Over Time in the OL Period|Change from baseline in participant serum values of ESR were calculated at all study visits in the OL period.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||IU / mL||Standard Error|Mean
176912|NCT00048568|Secondary|Mean BL Mental Component Summary of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 1,457, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176913|NCT00048568|Secondary|Mean Change From BL by Visit in the Physical Component Summary of the SF-36 in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176914|NCT00048568|Secondary|Mean BL Physical Component Summary of the SF-36 by Visit in the OL Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,093, Day 1,177, Day 1,261, Day 1,345, Day 14,57, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176915|NCT00048568|Secondary|BL and Mean Change From BL in Radiographic Erosion, Joint Space Narrowing (JSN), and Total Scores (TS) in the OL Period|Change from baseline in the Genant-modified Sharp erosion score, JSN, TS were evaluated for all participants at the end of the OL period. The total Genant-modified Sharp score (TS) ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145).Higher scores indicated more damage. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176916|NCT00048568|Secondary|Number of Participants Achieving HAQ Response Over Time for Participants Continuing in the OL Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
176917|NCT00048568|Primary|Participants With Immunogenicity to Abatacept in the Cumulative DB + OL Period|Participants with titers to abatacept in the DB and OL periods. Serum samples from abatacept-treated adult participants with active Rheumatoid Arthritis (RA) were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and or CTLA4-T.|Day 1 to Day 1,821|Participants with serum samples available for evaluation of titers to abatacept.||Participants|||Number
176918|NCT00048568|Primary|Mean Change From BL in Immunoglobulins in the OL Period||BL (Day 0), Day 365, Day 729, Day 1,093|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).||mg / mL||Standard Error|Mean
176919|NCT00048568|Primary|Mean BL Immunoglobulins Over Time in the OL Period|Mean baseline values are those that are reported for each cohort at each time point on Day 365, Day 729, and Day 1,093.|BL (Day 0), Day 365, Day 729, Day 1,093|All treated participants in the OL period (treatment groups represent treatment received in the double-blind period).||mg / mL||Standard Deviation|Mean
176931|NCT00048568|Secondary|Number of Participants With Liver and Kidney Function Tests Meeting Marked Abnormality Criteria in the DB Period|Marked abnormality criteria were: Aspartate Aminotransferase (AST) >3 * ULN or if BL > ULN then use >4 *BL; Alanine Aminotransferase (ALT) >3 * ULN or if BL > ULN then use > 4 * BL; Creatinine > 1.5 * BL.|Day 1 to Day 365|All treated participants in the DB period.||Participants|||Number
176921|NCT00048568|Secondary|Mean BL DAS-28 ESR Over Time in the OL Period|Mean baseline values are reported for each cohort at each time point. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||IU / mL||Standard Deviation|Mean
176922|NCT00048568|Secondary|Mean Change From BL in DAS-28 CRP Over Time for Participants Continuing in the OL Period|Change from baseline in participant were calculated at all study visits in the DB and OL periods.|BL(Day 0),Day 15,Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg / mL||Standard Error|Mean
176923|NCT00048568|Secondary|Mean BL DAS-28 CRP Over Time for Participants Continuing in the OL Period|Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL(Day 0), Day 15, Day 29,Day 57,Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg / mL||Standard Deviation|Mean
176924|NCT00048568|Secondary|Number of Participants Continuing in the OL Period With DAS-28 Remission or Low DAS-28 Activity Over Time|The DAS 28 is a continuous measure evaluating extent of disease activity in RA, and is a composite of 4 variables: the 28 tender joint count, the 28 swollen joint count, erythrocyte sedimentation rate (ESR) and participant assessment of disease activity measure on a visual analog scale (VAS) of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (> 5.1); low (≤ 3.2); remission (< 2.6).|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821, Day 1,989, Day 2,185|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
176925|NCT00048568|Secondary|Number of ACR 70 Responders in the DB and OL Periods|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
176926|NCT00048568|Secondary|Number of ACR 50 Responders in the DB and OL Periods|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
176927|NCT00048568|Secondary|Number of ACR 20 Responders in the DB and OL Periods|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, CRP or ESR, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365, Day 449, Day 533, Day 617, Day 729, Day 813, Day 897, Day 981, Day 1,083, Day 1,177, Day 1,261, Day 1,345, Day 1,497, Day 1,625, Day 1,821|All treated participants in the OL period (Treatment groups represent treatment received in the DB period). Due to the non-compliance of a single site, 3 participants were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
176928|NCT00048568|Secondary|Participant RF Seroconversion in the OL Period|This analysis determined participant RF status (positive or RF negative) based on serum samples at each specified timepoint. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.|Day 365, Day 729, Day 1,093, Day 1,457, Day 1,821, Day 2,185|All treated participants in the OL period. Treatment groups represent treatment received in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||Participants|||Number
177909|NCT00004054|Secondary|Distant Metastasis||From randomization to the date of metastatic disease or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.||||||
176932|NCT00048568|Secondary|Number of Participants With Hematology Laboratories Meeting Marked Abnormality Criteria in the DB Period|Marked abnormality criteria were: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 1 to Day 365|All treated participants in the DB period.||Participants|||Number
176933|NCT00048568|Secondary|Number of Participants Experiencing a 100% Reduction in Tender Joints or 100% Reduction in Swollen Joints in the DB Period||Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.||Participants|||Number
176934|NCT00048568|Secondary|Number of New Tender Joints and Number of New Swollen Joints in the DB Period|Tender joints and swollen joints are core components of the ACR 20, 50, and 70. The incidences of new tender joints and new swollen joints were evaluated in the DB period after 6 months and 1 year of treatment.|Day 169, Day 365|These data were not summarized as it was determined that no meaningful information would be obtained.||Joints|||Number
176935|NCT00048568|Secondary|Number of Participants With Immunogenicity to Abatacept in the DB Period|Participants with titers to abatacept in the DB period. Serum samples from abatacept-treated adult participants with active RA were screened for the presence of drug-specific antibodies using two validated direct-format enzyme-linked immunosorbent assays (ELISAs) to determine the presence of antibodies to abatacept and/or CTLA4-T.|Day 1 to Day 365|Participants treated with abatacept in the DB period with at least one immunogenicity sample collected in the DB period.||Participants|||Number
176936|NCT00048568|Secondary|Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.||Units on a Scale||Standard Error|Mean
176937|NCT00048568|Secondary|Adjusted Mean Change From BL in Individual Components of the HAQ DI at Day 169|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis.||Units on a Scale||Standard Error|Mean
176938|NCT00048568|Secondary|Mean BL Individual Components of the HAQ DI at Day 169 and Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176939|NCT00048568|Secondary|Participants Experiencing AEs of Special Interest in the DB Period|AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs were identified as those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion.|Day 1 to Day 365|All treated participants in the DB period.||Participants|||Number
176940|NCT00048568|Secondary|Participants Experiencing Clinically Significant Changes in Vital Signs in the DB Period|All changes in participant vital signs were monitored on each day of study drug administration prior to dosing and 60 minutes after dosing. Vital signs included body temperature, heart rate, and seated blood pressure. Clinical significance was defined as any change from baseline that resulted in a value outside the normal limits for the participant.|Day 1 to Day 365|All randomized and treated participants.||Participants|||Number
176941|NCT00048568|Primary|Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting the Marked Abnormality Criteria in the OL Period|Glucose: < 65 mg/dL or > 220 mg/dL; Fasting Glucose: <0.8 * LLN or > 1.5 * ULN or if BL < LLN then use < 0.8 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Total protein: < 0.9 * LLN or 1.1 * ULN or if BL < LLN then use 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Albumin: < 0.9 * LLN or if BL < LLN then use 0.75 * BL; Uric acid: > 1.5 * ULN or if BL > ULN then use > 2.0 * BL. All urinalysis abnormalities were defined as: if missing BL then use >= 2 or if value >=4, or if BL = 0 or 0.5 then use >= 2, or if BL = 1.0 then use >= 3, or if BL = 2.0 then use >=4.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
177039|NCT00048061|Secondary|Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
176942|NCT00048568|Primary|Participants With Electrolyte Values Meeting the Marked Abnormality Criteria in the OL Period|Sodium < 0.9 * LLN or > 1.05 * ULN or if BL < LLN then use < 0.95 * BL or > ULN or if BL > ULN then use >1.05 *BL or < LLN; Potassium: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use < 0.9 * BL or > ULN or if BL > ULN then use 1.1 * BL or < LLN; Chloride: < 0.9 * LLN or > 1.1 * ULN or if BL < LLN then use <0.9 * BL or >ULN or if BL > ULN then use > 1.1 * BL or < LLN; Calcium <0.8 * LLN or > 1.2 * ULN or if BL < LLN then use <0.67 * BL or > ULN or if BL > ULN then use > 1.3 * BL or < LLN.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
176943|NCT00048568|Primary|Participants With Liver and Kidney Function Values Meeting the Marked Abnormality Criteria in the OL Period|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
176944|NCT00048568|Primary|Participants With Hematology Values Meeting the Marked Abnormality Criteria in the OL Period|Marked abnormality criteria are: Hemoglobin (HGB): >3 g/dL decrease from BL; Hematocrit: <0.75 * BL; Erythrocytes: <0.75 * BL; Platelets (PLT): <0.67 * LLN/>1.5 * ULN, or if BL < LLN then use <0.5 * BL and <100,000 mm^3; Leukocytes: <0.75 * LLN/ >1.25 * ULN, or if BL<LLN then use <0.8 * BL or >ULN, or if BL>ULN then use >1.2 * BL or <LLN; neutrophils+bands: <1.0 * 10^3 c/uL; eosinophils: >0.750 * 10^3 c/uL; basophils: > 400 mm^3; monocytes: >2000 mm^3; lymphocytes: <0.750 * 10^3 c/uL/ >7.50 * 10^3 c/uL.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
176945|NCT00048568|Primary|Participants With Deaths, Adverse Events (AEs) and SAEs in the Open-Label (OL) Period|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 365 to Day 2,185|All treated participants in the OL period.||Participants|||Number
176946|NCT00048568|Secondary|Change From BL in Joint Narrowing Score (JSN), Erosion Score (ES), and Total Score (TS) by Category in the DB Period|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Improvement=decreases from BL, stable=same as BL, worsening=increases from BL.|BL (Day 0), Day 365|This analysis was not completed.||Participants|||Number
176947|NCT00048568|Secondary|Number of Participants Discontinuing in the DB Period|Participants that discontinued treatment during the DB period for any reason were evaluated after 6 months and 1 year of treatment.|Day 1 to Day 169, Day 170 to Day 365|All randomized and treated participants in the DB period.||Participants|||Number
176948|NCT00048568|Secondary|ACR Core Component: Mean CRP at All Post-BL Visits in the DB Period|CRP core component of the ACR scoring system was evaluated from serum samples in which increasing levels indicate increasing level of disease.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||IU / mL||Standard Deviation|Mean
176949|NCT00048568|Secondary|ACR Core Component: Mean Physician Global Assessment at All Post-BL Visits in the DB Period|Physician global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing very good global RA assessment and 100mm representing very poor global RA assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176950|NCT00048568|Secondary|ACR Core Component: Mean Participant Global Assessment at All Post-BL Visits in the DB Period|Participant self-reported global RA assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176951|NCT00048568|Secondary|ACR Core Component: Mean Participant Physical Function Assessment at All Post-BL Visits in the DB Period|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176952|NCT00048568|Secondary|ACR Core Component: Mean Participant Pain Assessment at All Post-BL Visits in the DB Period|Participant self-reported pain assessment core component of the ACR scoring system where increasing score indicates increasing level of severity as indicated on a 100mm Visual Analog Scale (VAS) with 0mm representing no pain and 100mm representing the most pain possible.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176953|NCT00048568|Secondary|ACR Core Component: Mean Number of Swollen Joints at All Post-BL Visits in the DB Period|The mean number of swollen joints in the DB period was evaluated based on the swollen joint core component of the ACR scoring system where increasing score indicates increasing level of severity. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||joints||Standard Deviation|Mean
176954|NCT00048568|Secondary|ACR Core Component: Mean Number of Tender Joints at All Post-BL Visits in the DB Period|Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last observation carried forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Joints||Standard Deviation|Mean
176955|NCT00048568|Secondary|Mean Change From BL in Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period|The mean change from baseline in sIL2-r in the DB period was evaluated for all treated participants.|BL (Day 0), Day 169, Day 365|All treated subjects in the DB period.||mg / mL||Standard Error|Mean
176956|NCT00048568|Secondary|Mean BL Soluble Interleukin-2 Receptors (sIL2-r) in the DB Period|The mean baseline sIL2-r in the DB period was evaluated from serum samples for all treated participants.|BL (Day 0), Day 169, Day 365|All treated subjects in the DB period. N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg / mL||Standard Deviation|Mean
176957|NCT00048568|Secondary|Adjusted Mean Change From BL in DAS-28 CRP and ESR in the DB Period|The mean change from baseline in CRP and ESR in the DB period was evaluated for all treated participants. Adjustment based on ANCOVA model with treatment as factor and baseline value as covariate.|BL (Day 0), Day 169, Day 365|Due to the closure of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. N = number of participants analyzed and n = the number of participants with measurements for that time point.||mg / mL||Standard Error|Mean
176958|NCT00048568|Secondary|Mean BL DAS-28 C-Reactive Protein (CRP) and ESR in the DB Period|The mean baseline CRP and ESR in the DB period on Day 169 and Day 365 was evaluated for all treated participants. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||mg / mL||Standard Deviation|Mean
176959|NCT00048568|Secondary|Participants in the DB Period Achieving an Extended Major Clinical Response|An extended major clinical response (MCR) was defined as a continuous ACR 70 response over any nine month treatment period with study medications. ACR 70 response criteria requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 1 to Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
176960|NCT00048568|Secondary|Adjusted Mean Change From BL in the Physical Component Summary of Health-Related Quality of Life (SF-36) in the DB Period|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). All subscales were scored using norm-based methods that standardized the scores to a mean of 50 and a standard deviation of 10 in the general population. The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Error|Mean
176970|NCT00048568|Secondary|ACR 50 Responders at Day 365|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
177551|NCT00025155|Secondary|Overall Survival|Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.|From study entry to death or last contact, up to 5 years of follow-up.|Eligible and treated participants.||Months||95% Confidence Interval|Median
176961|NCT00048568|Secondary|Mean DB BL Physical Component Summary of Health-Related Quality of Life (SF-36)|The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of > 3 points were considered clinically meaningful. Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population.Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176962|NCT00048568|Secondary|Mean DB BL and Mean Change From BL in Joint Space Narrowing (JSN) and Total Score (TS)|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions and joint space narrowing (JSN). The total Genant-modified Sharp score ranges from 0 (no radiographic damage) to 290 (worst possible radiographic damage) and is the sum of the erosion score (range 0-145) and the joint space narrowing score (range 0-145). Higher scores indicated more damage. Change from baseline = Post-baseline - Baseline value.|BL (Day 0), Day 365|All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Units on a Scale||Standard Deviation|Mean
176963|NCT00048568|Secondary|Number of Participants With Death, Serious Adverse Events (SAEs), Related SAEs, Discontinuation Due to SAEs, AEs, Related AEs, or Discontinued Due to AEs in the DB Period|AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment. SAE was defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event.|Day 1 to Day 365|All treated subjects in the DB period.||Participants|||Number
176964|NCT00048568|Secondary|Mean BL and Disease Activity Score 28 (DAS-28; Erythrocyte Sedimentation Rate [ESR]) at Day 169 and Day 365|The DAS 28 is an assessment of disease activity measured on a visual analog scale (VAS)of 100 mm. The scale reports from 1 to 10, with increasing number indicating increasing extent of disease progression. Scores for disease activity are defined as high (>5.1); low (≤3.2); remission (<2.6). Time-matched BL(Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.|BL (Day 0), Day 169, Day 365, Day 169, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis. Last Observation Carried Forward (LOCF) analysis. N = participants analyzed and n = participants with measurements for that time point.||Units on a Scale||Standard Deviation|Mean
176965|NCT00048568|Secondary|Number of Participants Achieving Major Clinical Response By Day 365|A Major Clinical Response (MCR) is defined as maintenance of an ACR 70 response over a continuous 6-month period.|Day 1 to Day 365. Data were collected monthly during the first 6 months and then every other month (with the exception of Day 337) during the second 6 months of the DB period.|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
176966|NCT00048568|Secondary|ACR 70 Responders in the DB Period|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
176967|NCT00048568|Secondary|ACR 70 Responders at Day 365|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
176968|NCT00048568|Secondary|ACR 70 Responders at Day 169|ACR 70 response requires a patient to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
176969|NCT00048568|Secondary|ACR 50 Responders in the DB Period|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
177910|NCT00004054|Secondary|Local Progression||From randomization to the date of local progression or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.||||||
176971|NCT00048568|Secondary|ACR 50 Responders at Day 169|ACR 50 response requires a patient to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
176972|NCT00048568|Secondary|ACR 20 Responders in the Double-Blind (DB) Period|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score.|Day 15, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 225, Day 281, Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
176973|NCT00048568|Secondary|ACR 20 Responders at Day 365|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
176974|NCT00048568|Secondary|BL Rheumatoid Factor (RF) Status for Participants Continuing in the OL Period|This analysis determined whether participants in the OL period were RF positive or RF negative based on serum samples. A positive value for RF was > 20 IU/ml; a negative value for RF was ≤ 20 IU/mL.|BL (Day 365)|All treated participants in the OL period (treatment groups represent treatment received in the DB period).||Participants|||Number
176975|NCT00048568|Secondary|Mean DB BL Participant Physical Pain Assessment, Participant Global Assessment, and Physician Global Assessment|Participant physical pain assessment was determined at baseline on the Visual Analog Scale (VAS) of 0 mm to 100 mm where 0mm is no pain and 100mm is worst pain possible. The mean participant global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 100 mm. The physician global assessment is a measure of overall disease burden and is a component of the ACR and evaluated using the VAS 0mm to 100 mm with 0mm indicating no disease burden and 100mm indicating worse disease burden possible.|BL (Day 0)|All randomized and treated participants in the DB period.||Units on a Scale||Standard Deviation|Mean
176976|NCT00048568|Secondary|Mean Number of Tender Joints and Swollen Joints at DB BL||BL (Day 0)|All randomized and treated participants in the DB period.||Joints||Standard Deviation|Mean
176977|NCT00048568|Primary|Baseline and Mean Change From Baseline (BL) in Radiographic Erosion Score Results at Day 365|To assess joint damage progression, the Genant-modified Sharp scoring method was used to evaluate radiographs of hands/wrists and feet for erosions. The erosion score range is 0 (no radiographic damage) to 145 (worst possible radiographic damage). Change from baseline = Post-baseline - Baseline value|BL (Day 0), Day 365|All randomized and treated participants in the DB period with radiographic data available at baseline and Day 365. Due to the compliance issues of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Units on a Scale||Standard Deviation|Mean
176978|NCT00048568|Primary|Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire (HAQ) at Day 365|The HAQ-DI includes 20 questions to assess physical function in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The domain questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ-DI=sum of worst scores in each domain dividied by the number of domains answered. HAQ-DI ranges from 0 to a maximum overall score of 3.0. Clinically meaningful HAQ response was defined as an improvement of at least 0.3 units from baseline in HAQ DI.|Day 365|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
176979|NCT00048568|Primary|Number of American College of Rheumatology 20 (ACR 20) Responders at Day 169|ACR 20 response requires a patient to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, patient global assessment of disease, patient assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire (HAQ) score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.|Day 169|Analyses of efficacy were based on the intent-to-treat population. Due to the non-compliance of a single site, 9 participants in the abatacept group and 5 in the placebo group were not included in this analysis.||Participants|||Number
176980|NCT00048542|Other Pre-specified|Baseline Measure: Age Continuous - OLE FD Phase|Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.|Baseline OLE FD Phase|||Years||Standard Deviation|Mean
176981|NCT00048542|Other Pre-specified|Baseline Measure: Gender, Female/Male - OLE FD Phase|Gender (female/male) recorded at Baseline of the Open-Label Extension FD phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section while including this phase of the study.|Baseline OLE FD Phase|||Participants|||Number
176982|NCT00048542|Other Pre-specified|Baseline Measure: Age Continuous - OLE BSA Phase|Age continuous (mean +/- SD) recorded at Baseline of the Open-Label Extension BSA phase of the study. This measure was excluded from Baseline Characteristics due to difficulty maintaining correct subject numbers and Baseline value totals in that section with this phase included.|Baseline OLE BSA Phase|||Years||Standard Deviation|Mean
176984|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. Final Visit = last visit per subject (up to 224 weeks).|Final Visit (up to 224 weeks of OLE FD phase)|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.||Participants|||Number
176985|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 112|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.||Participants|||Number
176986|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 48|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.||Participants|||Number
176987|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL-LI baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Baseline|The ITT population was used for analysis in the Open-Label Extension Fixed Dose phase.||Participants|||Number
176988|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 104|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.||Participants|||Number
176989|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Week 56|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.||Participants|||Number
176990|NCT00048542|Secondary|Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase|Responders met the following criteria: >= 30%/50%/70% improvement in >= 3 of 6 JIA core criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; # of active joints (joints with swelling or with LOM and with pain, tenderness or both); # of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core assessments are included in PedACR criteria.|Open-Label Lead-In Phase Baseline|The ITT population was used for analysis in the Open-Label Extension Body Surface Area phase.||Participants|||Number
176991|NCT00048542|Secondary|Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase|Serum levels of C-reactive protein (CRP) were measured at screening (open-label baseline) and at Week 48. Negative mean changes in CRP from open-label baseline to Week 48 indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.||mg/dL||Standard Error|Mean
176992|NCT00048542|Secondary|Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase|A 100 mm horizontal visual analog scale (VAS) was used to assess the Parent's/Patient's Global Assessment of Disease Activity. The left end of the VAS (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.||Units on a scale||Standard Error|Mean
176993|NCT00048542|Secondary|Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase|A 100 mm horizontal visual analog scale (VAS) was used to assess the Physician Global Assessment of Disease Activity. The left end of the VAS scale (0 mm) signified the absence of symptoms and the right end (100 mm) maximum disease activity. The mean change from open-label baseline to Week 48 was determined. Negative mean changes indicated improvement.|Baseline and Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, who completed Week 48. Observed data of subjects who remained in the study at Week 48 were analyzed.||Units on a scale||Standard Error|Mean
176994|NCT00048542|Secondary|Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 70% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.||Participants|||Number
176995|NCT00048542|Secondary|Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 50% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core variables are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.||Participants|||Number
176996|NCT00048542|Secondary|Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase|Responders met the following criteria: >= 30% improvement in >= 3 of 6 JIA core set criteria, and >= 30% worsening in not more than 1 JIA criterion, compared with the OL baseline. JIA core criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein. All core criteria are included in PedACR criteria.|Week 48|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.||Participants|||Number
176997|NCT00048542|Secondary|Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum|A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum.||Percent participants w/o disease flare|||Number
176998|NCT00048542|Secondary|Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum|A log rank test was performed and the Kaplan-Meier curve for time to disease flare from double-blind baseline (Week 16) to Week 48 was generated. Disease flare was defined as a >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. The percentage of subjects without disease flare at each time point is presented.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum.||Percent participants w/o disease flare|||Number
176999|NCT00048542|Secondary|Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase|Subjects met criteria for disease flare if they had >= 30% worsening in at least 3 of 6 JRA core set criteria and a minimum of 2 active joints, and >= 30% improvement in not more than 1 JRA criterion. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with LOM and with pain, tenderness or both); number of joints with LOM; physical function of Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16 to Week 48 (32 Weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the MTX stratum. Missing values were treated as disease flare.||Participants|||Number
177000|NCT00048542|Secondary|Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase|Responders met the following criteria: >= 30% improvement in >= 3 of 6 JRA core set criteria, and >= 30% worsening in not more than 1 JRA criterion, compared with the open-label baseline. JRA core set criteria included: physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion [LOM] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.|Week 16|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug. Missing values were treated as non-responders.||Participants|||Number
177040|NCT00048061|Secondary|Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
177001|NCT00048542|Primary|Number of Subjects in the Non-MTX Stratum With Disease Flare During the Double-Blind Phase|The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) >= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) >= 30% improvement in not more than 1 of the 6 JRA core set criteria.|Week 16 to Week 48 (32 weeks)|All subjects in the intent-to-treat population, defined as all subjects who were randomized and who received at least a single administration of study drug, in the non-MTX stratum. Missing values were treated as disease flare.||Participants|||Number
177002|NCT00048347|Primary|Percent of Participants With at Least a 3 Point Drop in the Short Clinical Colitis Score (SCCAI)|The primary endpoint is the percent of patients with a clinical response as defined by a drop in the Short Clinical Colitis Score (SCCAI) of at least 3 points from Week 0 to Week 12. Short Clinical Colitis Score (SCCAI): Bowel frequency(day0-3,night0-2),urgency(0-3),rectal bleeding(0-3),well being(0-4),extracolonic features(0-4), total score 0(best)-19(worst).|Baseline, Week 12|||Percent of participants|||Number
177003|NCT00048165|Secondary|Number of Participants With Malignancies and Opportunistic Infections|The opportunistic infections included infections with Cytomegalovirus, Aspergillus, Candida, Pneumocystis, Cryptococcus, Listeria, Herpes simplex, Herpes zoster. For malignancy, participants with any type of malignancy whose date of onset or diagnosis was after randomization was reported.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc).||participants|||Number
177004|NCT00048165|Secondary|Number of Participants With Any Adverse Events and Any Serious Adverse Event, and Adverse Events Leading to Premature Withdrawal|An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc).||participants|||Number
177005|NCT00048165|Secondary|Number of Participants With Marked Laboratory Abnormalities: Biochemistry Parameters|A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Biochemistry included blood urea nitrogen, creatinine, serum glutamic oxalacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transferase (GGT), phosphorous, total bilirubin, direct bilirubin, total protein, albumin, glucose, alkaline phosphatase, low density lipoprotein (LDH), uric acid, carbon dioxide, magnesium, sodium, potassium, chloride, calcium, LDL, HDL, total cholesterol, and triglycerides.|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). The number of participants analyzed for the specified parameters are denoted by ‘n’.||participants|||Number
177006|NCT00048165|Secondary|Number of Participants With Marked Laboratory Abnormalities: Hematology Parameters|A marked reference range was predefined by Roche. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range (low or high) that also represent a defined change from Baseline were considered marked laboratory abnormalities (i.e. potentially clinically relevant). Hematology included hemoglobin, hematocrit, white blood cell count (WBC) with differential (including granulocytes or neutrophils, basophils, eosinophils, monocytes, lymphocytes), platelets, and erythrocyte count|Up to 12 months|Safety population included all participants who received at least one dose of study drug (daclizumab or placebo) or commercially available daclizumab and have at least one post-baseline safety assessment (eg. any laboratory data, adverse event, etc). The number of participants analyzed for the specified parameters are denoted by ‘n’.||participants|||Number
177007|NCT00048165|Secondary|Median Change From Baseline for LDL/HDL Ratio||From Baseline (Day -2) to 3 months, and 6 months|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||ratio||Full Range|Median
177008|NCT00048165|Secondary|Median Change From Baseline for Lipid Profile (Total Cholesterol, Low Density Lipoproteins, High Density Lipoproteins, and Triglycerides)|Lipid profile included total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL), and triglycerides (all total cholesterol, LDL, HDL, and triglycerides with unit milligram per decilitre [mg/dL]), were reported. The median change from baseline (Day -2) in lipid profile values at 3 months and 6 months was reported.|From Baseline (Day -2) to 3 months and 6 months|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified parameters are denoted by 'n'.||mg/dL||Full Range|Median
177009|NCT00048165|Secondary|Mean Maintenance Doses of Mycophenolate Mofetil, Cyclosporine, and Cumulative Dose of Corticosteroids at 6 and 12 Months PT|The maintenance doses of mycophenolate mofetil (1.5g twice a day daily), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg oral [PO]/nasogastric [NG] within 72 hours post-operative]), and cumulative dose of corticosteroids (500-1000 mg IV methylprednisolone pre-operative switched to oral at 0.5-1 mg/kg/day. Tapered to 0.2 mg/kg/d by Day 28, 0.1-0.15 mg/kg/day from Days 36 to 90, and 0.1-0.15 mg/kg/day from Days 120 to 180)at 6 and 12 months PT were reported. Maintenance dose was calculated as total dose per day summed over all days that a participant was administered drug within the specified time interval, divided by number of days that a participant took drug within that time interval.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'.||mg||Standard Deviation|Mean
177010|NCT00048165|Secondary|Number of Participants Using Monomurab Cluster of Differentiation 3, Orthoclone Polyclonal Antithymocyte Globulin or Antilymphocyte Globulin in the First 6 Months and 12 Months PT|The number of participants who received monomurab Cluster of differentiation 3, orthoclone, polyclonal antithymocyte globulin or antilymphocyte globulin for treatment of biopsy proven rejection or HDC within 6 and 12 months PT were reported.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
177011|NCT00048165|Secondary|Median Time to First Acute Rejection Episode Within the First 6 Months and 12 Months PT|The median time to first acute rejection episode within first 6 months and 12 months PT was reported.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not. The number of participants analyzed for the specified timepoints are denoted by 'n'.||days||Full Range|Median
177012|NCT00048165|Secondary|Number of Participants With Worst ISHLT Biopsy Grade Within First 6 Months and 12 Months PT|The number of participants with Worst International Society of Heart and Lung Transplant (ISHLT) grade within first 6 months and 12 months PT were reported. ISHLT is a standardized grading method to determine the acute cellular rejection on endomyocardial biopsy ; where 0= no rejection, IA= focal (perivascular or interstitial) infiltrate without necrosis, IB= diffuse but sparse infiltrate without necrosis, II=one focus only with aggressive infiltration and/or focal myocyte damage, IIIA=multifocal aggressive infiltrates and/or myocyte damage, IIIB= diffuse inflammatory process with necrosis, IV= diffuse aggressive polymorphous and/or infiltrate and/or edema and/or hemorrhage and/or vasculitis, with necrosis|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
177013|NCT00048165|Secondary|Number of Participant Who Died Within 6 Months 12 Months and 3 Years PT|The survival of the graft and participants at 6,12 months and 3 years PT was reported|At 6 months, 12 months , 3 years PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
177014|NCT00048165|Secondary|Number of Acute Rejection Episodes Per Participant Within the First 6 Months and 12 Months PT|The number of participants with 0,1, 2, 3 or 4 episodes at 6 and 12 months PT were reported. An episode of acute rejection was defined according to the date of positive biopsy of Grade IIIA or worse or the date of start of treatment for HDC, whichever came first.|Within 6 months and 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
177015|NCT00048165|Secondary|Number of Participants Who Developed Acute Rejection Episode Within the 12 Months PT|The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months. Participants with acute rejection included participants with a biopsy histology of ISHLT Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up|Up to 12 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
177016|NCT00048165|Primary|Number of Participants Who Developed Acute Rejection Episode Within 6 Months Post-Transplant|The acute rejection episode was a composite end-point of acute rejection and treatment failure within 6 months post-transplant (PT). Participants with acute rejection included participants with a biopsy histology of International Society of Heart and Lung Transplant (ISHLT) Grade IIIA, IIIB, or IV and participants with hemodynamic compromise (HDC) who were treated for acute rejection (whether or not a biopsy was done and regardless of the grade of the biopsy). Participants who had treatment failure included participants who died within 6 months of transplantation before experiencing acute rejection or who were re-transplanted within 6 months of the primary transplantation and who did not experience an acute rejection or who were lost to follow-up.|Up to 6 months PT|The randomized population included all participants who were randomized into the study, whether they received the study drug or not.||participants|||Number
177017|NCT00048074|Secondary|Number of Participants With Any Marked Abnormality in Laboratory Parameters|Marked laboratory test value abnormalities (high and low) are those which exceed the marked reference range (i.e., a reference range greater than the standard reference range) and which also represents a clinically relevant change from baseline of at least a designated amount. The indicated abnormal laboratory parameters (along with their marked reference range) are as follows: low and high Hematocrit (0.36 - 0.60 fraction), low and high hemoglobin (11.0 - 20.0 g/dL), low and high platelets (100 – 700 * 10^9/L), low and high white blood cell (WBC) (3.0 - 18.0 * 10^9/L), high alanine aminotransferase (ALAT) (0 – 60 U/L), high blood urea nitrogen (BUN) (0 - 14.3 mmol/L) , high creatinine (0 – 154 mmol/L), low albumin (27.0 - 48.0 g/L), low and high chloride (95 – 115 mmol/L), low potassium (3.0 - 6.0 mmol/L), low sodium (130 – 150 mmol/L), high calcium (2.00 - 2.90 mmol/L), low and high phosphate (0.75 - 1.60 mmol/L).|Approximately 2 years|Safety Population: All participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point. Only participants with data available for the indicated laboratory abnormality were analyzed.||participants|||Number
177018|NCT00048074|Secondary|Number of Participants Who Experienced Any Adverse Events (AEs) or Serious Adverse Events (SAEs)|An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Approximately 2 years|Safety Population: All participants who were randomized and had at least one dose of study drug, whether withdrawn prematurely or not, and who had at least one follow-up data point.||participants|||Number
177019|NCT00048074|Secondary|Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
177020|NCT00048074|Secondary|Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
177021|NCT00048074|Secondary|Percentage of Participants With Mean Total Hip and Lumbar Spine BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean total hip and mean lumbar spine BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
177022|NCT00048074|Secondary|Percentage of Participants With Femoral Neck BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean femoral neck BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
177023|NCT00048074|Secondary|Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
177024|NCT00048074|Secondary|Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean total hip BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
177025|NCT00048074|Secondary|Percentage of Participants With Mean Lumbar Spine (L2 – L4) BMD Above or Equal to Baseline at Month 12 and 24|A participant is a responder if the mean lumber spine (L2 – L4) BMD had remained the same or increased above baseline. Only participants with data available at particular timepoint were analyzed.|At Month 12 and 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percentage of participants|||Number
177026|NCT00048074|Secondary|Absolute Change From Baseline in Serum CTX at Month 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The absolute change from Baseline in serum CTX was defined as the difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.|Baseline, At Month 6, 12, and 24.|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Absolute Change (ng/mL)||Standard Deviation|Mean
177027|NCT00048074|Secondary|Relative Change From Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen (CTX) at Month 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was measured using the Elecsys s-CTX-I assay, an electrochemiluminescence immunoassay (ECLIA) technique. Samples for serum CTX measurements were collected from participants immediately prior to their IV dosing. Thus, the values reported here represent trough or residual values taken at the end of the 2 month or 3 month IV dosing interval. The change in serum CTX was defined as the relative difference between the last individual measurement available at Month 6 or Month 12 or Month 24 and Baseline, using the following formula: Relative change = 100 x (CTX at Month 6/Month 12/Month 24- CTX at Baseline) / (CTX at Baseline). Only participants with data available at particular timepoint were analyzed.|Baseline, At Month 6, 12, and 24.|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percent Change||Standard Deviation|Mean
177028|NCT00048074|Secondary|Absolute Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24|BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24. The absolute change in BMD was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Absolute Change (g/cm^2)||Standard Deviation|Mean
177911|NCT00004054|Secondary|Biochemical Control||From randomization to the date of prostate-specific antigen (PSA) failure per the American Society for Radiation Oncology (ASTRO) definition or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.||||||
177029|NCT00048074|Secondary|Relative Percent Change From Baseline in BMD of Proximal Femur (Consisting of Total Hip, Trochanter, and Femoral Neck) at Month 12 and 24|BMD was measured by a single DXA scan of the proximal femur at the time of screening, Month 12 and Month 24.The change in BMD of the proximal femur (total hip, trochanter, femoral neck) was defined as the relative difference between the last individual measurement available at Month 12 or Month 24and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year/2year - BMD at Baseline) / (BMD at Baseline). BMD of fractured bones that could impact the scan area were not taken into account. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percent Change||Standard Deviation|Mean
177030|NCT00048074|Secondary|Absolute Change From Baseline in Mean BMD of Lumbar Spine (L2 – L4) at Month 12 and Month 24|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at screening, Month 12 and Month 24. The absolute change from Baseline in mean BMD of the lumbar spine (L2-L4) was defined as the difference between the last individual measurement available at Month 12 or Month 24 and Baseline. Only participants with data available at particular timepoint were analyzed.|Baseline, Month 12 and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Absolute Change (g/cm^2)||Standard Deviation|Mean
177031|NCT00048074|Secondary|Relative Percent Change From Baseline in Mean BMD of Lumbar Spine (L2-L4) at 24 Months|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 24. The change in BMD was defined as the relative difference between the last individual measurement available at 24 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)|Baseline and Month 24|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percent Change||Standard Deviation|Mean
177032|NCT00048074|Primary|Relative Percent Change From Baseline in Mean Bone Mineral Density (BMD) of Lumbar Spine (L2-L4) at 12 Months|BMD was measured by a single dual-energy x-ray absorptiometry (DXA) scan of the lumbar spine at the time of screening and at Month 12. The change in BMD was defined as the relative difference between the last individual measurement available at 12 months and Baseline, using the following formula: Relative change = 100 x (BMD at 1 year - BMD at Baseline) / (BMD at Baseline)|Baseline and Month 12|Per protocol population: Participants who were randomized, received at least one dose of study medication and had at least one efficacy (BMD or serum CTX) follow-up data point and did not have any major violations of the protocol.||Percent Change||Standard Deviation|Mean
177033|NCT00048061|Secondary|Number Of Participants With Marked Laboratory Abnormalities|Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from baseline. The reference range for hemoglobin was 110-200 (gram per liter [g/L]), hematocrit was 0.31-0.56 fraction, white blood cells (WBC) was 3.0-18.0 (10*9/L), serum glutamic-pyruvic transaminase (SGPT/ALT) was 0-110 IU/L, blood urea nitrogen (BUN) was 0.0-14.3 (millimoles per Liter [mmol/L]), Chloride was 95-115 (mmol/L), Potassium was 3.0 – 6.0 (mmol/L), Sodium was 130-150 (mmol/L), Calcium was 2.00-2.90 (mmol/L), Phosphate was 0.75 – 1.60 (mmol/L) and Creatinine was 0- 154 (micromoles/liter [umol/L].|Up to Month 24|The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point. n = number of participants evaluable at particular time of assessment.||Participants|||Number
177034|NCT00048061|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Event|An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.|Up to Month 24|The safety population consisted of all participants who were randomized and received at least one dose of the study medication, and who have at least one follow-up data point.||Participants|||Number
177035|NCT00048061|Secondary|Absolute Change In Baseline in Serum CTX to Months 12 and 24|Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||ng/ml||Standard Deviation|Mean
177036|NCT00048061|Secondary|Relative Change In Baseline in Serum C-telopeptide of Alpha-chain of Type I Collagen [ CTX] ] to Months 3, 6, 12, and 24|Serum CTX, a biochemical marker of bone resorption, was assessed using the Elecsys S-CTX-I assay (an ElectroChemiLuminescence Immunoassay (ECLIA) Technique).|From Baseline (Month 0) to Months 3, 6, 12, 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
177037|NCT00048061|Secondary|Percentage of Participants With Mean Femoral Neck and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean femoral neck and lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
177038|NCT00048061|Secondary|Percentage of Participants With Mean Trochanter and Lumbar Spine BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean trochanter and lumbar spine BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
177041|NCT00048061|Secondary|Percentage of Participants With Trochanter BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean trochanter BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
177042|NCT00048061|Secondary|Percentage of Participants With Total Hip BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean total hip BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
177043|NCT00048061|Secondary|Percentage of Participants With Mean Lumbar Spine (L2 - L4) BMD Above or Equal to Baseline at Months 12 and 24|A participant is a responder if the mean lumber spine (L2 – L4) BMD had remained the same or increased above baseline.|Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percentage of participants|||Number
177044|NCT00048061|Secondary|Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD.|Proximal femur BMD was measured by dual-energy X-ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||g/cm2||Standard Deviation|Mean
177045|NCT00048061|Secondary|Relative Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Proximal Femur ( Total Hip, Trochanter, Femoral Neck) BMD|Proximal femur BMD was measured by dual-energy X ray absorptiometry at baseline, after one and two years of treatment and was read by a central reading center.|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||Percent change||Standard Deviation|Mean
177046|NCT00048061|Secondary|Absolute Change From Baseline at One Year (12 Months) and Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD|The absolute change (g/cm^2) from baseline in mean BMD of the lumbar spine (L2 – L4) at one and two years. A difference in the mean values between the active groups and the control was calculated.|From Baseline (Month 0) to Months 12 and 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol. n = number of participants evaluable at particular time of assessment.||g/cm2||Standard Deviation|Mean
177047|NCT00048061|Secondary|Relative Change From Baseline at Two Years (24 Months) in Mean Lumbar Spine (L2-L4) BMD|Relative change in BMD is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 24 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 24.|From Baseline (Month 0) to Month 24|The PP population consisted of all participants in the ITT population who had no major violations of the protocol.Participants available at particular time point for assessment were included in the analysis.||Percent change||Standard Deviation|Mean
177048|NCT00048061|Primary|Relative Change From Baseline at One Year (12 Months) in Mean Lumbar Spine (L2 – L4) Bone Mineral Density|Relative change in Bone Mineral Density (BMD) is the percentage change from baseline of BMD of vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process to such a degree that accurate measurement of BMD would be considered jeopardized by the central reading center after 12 months of treatment. It is calculated as the sum of bone mineral content divided by the sum of area of all lumbar vertebrae L2 - L4 that are not fractured and not affected by an osteoarthritic process at Month 12. Participants available at particular time point for assessment were included in the analysis.|From Baseline (Month 0) to Month 12|The per-protocol(PP) population included participants in Intent-to-treat(ITT) population who were randomized, received at least one dose of medication and had at least one valid efficacy(BMD or Serum CTX)follow-up data point;defined as any measurement that can be scientifically compared to baseline measurement, and had no major protocol violations.||Percent change||Standard Deviation|Mean
177049|NCT00048035|Secondary|Mean Change in Pulse Rate|Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug||BpM||Standard Deviation|Mean
177050|NCT00048035|Secondary|Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis|Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week –1).|From Baseline (Day -28 to Day 1) to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||mm HG||Standard Deviation|Mean
177051|NCT00048035|Secondary|Number of Participants With Marked Laboratory Abnormalities|Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0– 18.0 10^9/L), Platelets (100 – 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 – 220 U/L), Aspartate aminotransferase (ASAT) (0 – 80 U/L), Albumin >= 30 g/L, Phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], Potassium (2.9 – 5.8 mmol/L), Glucose (2.80 – 11.10 mmol/L).|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||Participants|||Number
177052|NCT00048035|Secondary|Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths|An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator’s judgment or requires intervention to prevent one or other of these outcomes. ). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.|Up to Week 126|The safety population was considered for analysis which included all participants who received at least one dose of study drug.||Participants|||Number
177053|NCT00048035|Secondary|Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The Intent-to-Treat (ITT) population was defined as all randomized participants.||g/dL||Inter-Quartile Range|Median
177054|NCT00048035|Primary|Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen|Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week –1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.|From Baseline (Day -28 to Day 1) to EOIT (Week 19)|The Intent-to-Treat (ITT) population was defined as all randomized participants.||g/dL||Inter-Quartile Range|Median
177055|NCT00047879|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|4 months|||Participants|||Number
177056|NCT00047879|Secondary|Number of Participants With Complete or Partial Response|"Response is defined per RECIST criteria. Measurable disease is defined as bidimensionally measurable lesions with clearly defined margins by CT or MRI scan.~Evaluable disease is defined as unidimensionally measurable lesions, masses with margins not clearly defined, or lesions with a multiple cystic component.~Complete response (CR) is complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to 50% decrease under baseline in the sum of products or perpendicular diameters of all measurable lesions."|6 months|Registered 7 out of 64 participants and they came off study for progressive disease around 3-4 months after starting the study.||Participants|||Number
177057|NCT00047879|Primary|Progression-free Survival|"Progression free survival is defined as the percent of patients that are progression free and alive 6 months after initiating therapy.~Progression of disease by > 50% increase in the size of the tumor compared to baseline after the first cycle only, and then >25% increase in the size of the tumor for all subsequent cycles."|6 months|The primary objective was not met. Only registered 7 out of 64 participants and they all came off the study for progressive disease around 3-4 months after starting the study. None of the participants were evaluated for progression-free survival at 6 months because the study was stopped at 4 months due to progressive disease.||Percent of participants|||Number
177058|NCT00047619|Primary|Pressure Ulcer Volume Measurement|Volume of pressure ulcer was measured by the amount of fluid that could be used to fill the pressure ulcer which was covered by an occlusive dressing|study participation - up to 6 weeks|||cm^3||95% Confidence Interval|Mean
177059|NCT00047619|Primary|Pressure Ulcer Geometry|Linear assessment of wounds|study participation - up to 6 weeks|||cm||95% Confidence Interval|Mean
177060|NCT00047463|Secondary|Number of Patients Requiring Only One Night of Baseline Sleep Study to Detect Sleep Apnea|The data presented below represent the number of participants who required only one night of baseline sleep study prior to randomization|prior to randomization|These are participants that were enrolled and assessed to determine if one night of baseline sleep study was sufficient to detect sleep apnea. This occurred prior to randomization. Five of the assessed participants were not randomized.||Participants|||Number
177061|NCT00047463|Secondary|Number of Patients That Were Able to be Blinded to CPAP or Placebo CPAP|Patients all received a CPAP machine which either delivered CPAP or provided the patient with placebo CPAP, which had the same sensation as receiving CPAP|10 weeks|||participants|||Number
177062|NCT00047463|Primary|CPAP Adherence/Tolerance as Measured by Proportion of Nights Used|This measure quantifies how well patients use their CPAP. The standard unit of measurement is proportion of nights that the CPAP is used by a participant (total nights used/total nights the device could have been used), averaged across all participants . Data were downloaded by a card placed in the CPAP machine reflecting use over the entire 10 weeks.|10 weeks|||proportion of nights used (total nights||Standard Deviation|Mean
177063|NCT00047385|Secondary|T2 Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T2. Includes a comparison with images from T0 and T1 screens.|T2 (two years after entry)|All participants randomized were analyzed||Participants|||Number
177064|NCT00047385|Secondary|T1 Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T1. Includes a comparison with images from T0 screen.|T1 (one year after entry)|All participants randomized were analyzed||Participants|||Number
177065|NCT00047385|Secondary|T0 (Baseline) Screening Results|Results of radiologist's interpretation of images from LDCT or CXR screening exam at T0.|T0 (at study entry)|All participants randomized were analyzed.||Participants|||Number
177066|NCT00047385|Secondary|Complications of Diagnostic Evaluation Following a Positive Screening Test.|Number of participants who experienced complications during diagnostic work-up of a screening CT or CXR that was suspicious for lung cancer.|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If participant received 3 positive screens with documented follow-up after each one, he/she would be counted 3 times in the number of units analyzed.||Pos. screens w/ complications|Participants||Number
177067|NCT00047385|Secondary|Lung Cancer Diagnoses|Lung cancer diagnoses confirmed by medical record abstraction.|All events through December 31, 2009; median follow-up 6.5 years|All participants randomized were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
177068|NCT00047385|Secondary|Deaths From All Causes in All Randomized Participants.|Deaths from all causes were compared between the low-dose CT group and the chest radiography group among all randomized participants.|All events through December 31, 2009; median follow-up 6.5 years.|All participants randomized were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
177069|NCT00047385|Primary|Lung Cancer Deaths|Lung cancer deaths confirmed in participants by Endpoint Verification if available, otherwise by death certificate.|All events through December 31, 2009; median follow-up 6.5 years.|All participants randomized were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
177070|NCT00047320|Secondary|Occurrence of Nonhematological Grade 4 Toxicity||18 weeks||||||
177071|NCT00047320|Secondary|Toxic Death|Defined as death predominantly attributable to treatment-related causes.|18 weeks||||||
177072|NCT00047320|Secondary|Overall Survival||Time from study entry to death from any cause||||||
177073|NCT00047320|Secondary|Progression-free Survival|From study entry to disease progression or recurrence. Deaths that are clearly unrelated to disease progression, and second neoplasms, are censored in this analysis.|From the time of the first progressive, non-metastatic event until the subsequent occurrence of relapse or progressive disease||||||
177074|NCT00047320|Secondary|Event-free Survival||From time from study entry to death from any cause, disease progression or recurrence, or second malignant neoplasm.||||||
177075|NCT00047320|Primary|Response to Induction Chemotherapy|A patient who achieves a complete or partial response, defined a reduction of at least 65% in tumor size without complete disappearance of tumor after induction chemotherapy will be considered to have experienced response.|18 weeks|Of the 101 eligible patients, 85 completed induction chemotherapy with sufficient data to assess response. Central review response assessment is used.||participants|||Number
177076|NCT00047008|Secondary|Correlation of COX-2 With Outcomes||From randomization to date of death or last follow-up||||||
177077|NCT00047008|Secondary|Correlation of Epidermal Growth Factor Receptor(EGFR) With Outcomes||From randomization to date of death or last follow-up||||||
177078|NCT00047008|Secondary|Quality of Life||From randomization to 5 years||||||
177079|NCT00047008|Secondary|Rate of Grade 3-5 Toxicity||From start of treatment to last follow-up||||||
177080|NCT00047008|Secondary|Disease-free Survival|From randomization to date of failure (local or regional persistence/relapse, distant metastasis, secondary primary tumor or death) or last follow-up. Analysis occurs after 309 deaths have been reported.|From randomization to date of failure||||||
177081|NCT00047008|Secondary|Local-regional Control|From randomization to date of failure (local or regional persistence/relapse) or death or last follow-up. Analysis occurs after 309 deaths have been reported.|From randomization to date of failure||||||
177082|NCT00047008|Primary|Overall Survival (3-year Rate)|Time from randomization to death due to any cause or last known date alive. Median survival was not reached, therefore 3-year survival rates are reported.|From randomization to date of death or last follow-up. Analysis occurs after 309 deaths have been reported.|Eligible patients who did not withdraw consent.||percentage of patients||95% Confidence Interval|Number
177083|NCT00046930|Secondary|Response|Number of eligible participants in each response category. Categories, based on peripheral blood counts and bone marrow aspirate and biopsy, include complete remission (CR), partial remission (PR), morphologic complete remission (MCR), and relapse.|Assessed at the end of induction|||Participants|||Number
177084|NCT00046930|Secondary|Progression-free Survival (PFS)|Time from randomization to the earlier of disease progression or death. Patients alive and progression-free at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Eligible participants, as randomized. Patients who had neither documented progression nor death within 3 months of registration without disease evaluation were excluded.||Months||95% Confidence Interval|Median
177085|NCT00046930|Primary|Overall Survival (OS)|Time from randomization to death. Patients alive at last follow-up were censored.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Eligible participants, as randomized||Months||95% Confidence Interval|Median
177086|NCT00046891|Secondary|Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.|Pearson correlation coefficients conceptually related objective TMT A and B and subjective self-report measures of cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.||Pearson correlation coefficient|||Number
177087|NCT00046891|Secondary|Associations Between Self-reported Cognition and the HSCS.|Pearson correlation coefficients conceptually related objective HSCS and subjective self-reported cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.||Pearson correlation coefficient|||Number
177118|NCT00046228|Secondary|Complications of MI as Defined in the Primary Outcome Measure Through 90 Days|The complications of myocardial infarction (MI) is defined as any event of rehospitalization or emergency department visit for CHF, cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization.|90 Days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects that have been randomly assigned to a treatment group and classified according to the randomization assignment.||participants|||Number
177088|NCT00046891|Secondary|Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)|Self-reported symptoms or side effects mean change from baseline to 1st post chemo visit (negative numbers indicate worsening symptoms). A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire. This patient diary contains several questions related to potential side effects and side benefits of Ginko Biloba measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity).|Baseline, 1st evaluation of post chemotherapy.|Secondary analyses uses all patients that reported data for baseline and post chemo visit.||units on a scale||Standard Deviation|Mean
177089|NCT00046891|Secondary|Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.|TMT A and B were analyzed by evaluating median changes from baseline to different time points. Lower scores are better. The Trail Making Test will provide additional validity and verification for the assessment of overall cognitive dysfunction. Abbreviations used for category titles in the table below: Baseline (BL), change (chg), month (mth).|Baseline, 1, 6, 12, 18 and 24 months post chemotherapy.|Secondary analysis uses all patients that reported baseline and at least one post baseline time point data.||seconds||Full Range|Median
177090|NCT00046891|Secondary|Median Scores for Trail Making Tests A and B (Lower Scores Are Better).|The Trail Making Test is a measure of overall brain dysfunction. Time taken to complete TMT tests was recorded. For this analysis median values of the Trail Making tests are calculated at different time points.|Baseline, 1, 6, 12, 18 and 24 months time points|Secondary analyses uses all patients that reported data for all the time points.||seconds||Full Range|Median
177091|NCT00046891|Primary|The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.|The primary analysis involved compiling each subscale score for the HSCS into area under the curve (AUC) scores for the data points from baseline to the 12 month data point. HSCS instrument contains questions regarding Memory (0-39), Language (0-30), Visual-motor (0-10), Spatial (0-8), Attention and Concentration (0-25), Self-Regulation and Planning (0-6) on a varying scales. Total is calculated by summing afore mentioned subscales, values of Total ranged from 0 to 125. Lower scores are better.|Baseline, 12 months after starting Chemotherapy.|Efficacy analyses uses all patients that reported baseline and one value after baseline.||units on a scale*months||Standard Deviation|Mean
177092|NCT00046839|Primary|Overall Survival|Because only 21 patients (18 analyzable) out of 128 planned were accrued on this study, all analyzable patients were combined to report overall survival. The original study design planned for a comparison to a historical control, but due to the small number of patients, survival time is only reported, not tested.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.|Eligible patients who started protocol treatment.||years||95% Confidence Interval|Median
177093|NCT00046839|Primary|Maximum Tolerated Dose (MTD) of Celecoxib Combined With Radiation Therapy (RT)|"Patients were followed for at least 90 days from start of RT and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as grade 3 or 4 nonhematologic (excluding nausea, vomiting, and alopecia) and grade 4 hematologic toxicities. Six patients were to be accrued at each dose level. If no more than three of the six patients experienced a DLT then that dose level was considered acceptable and dose escalation occurred by accruing six more patients at the next dose level. Otherwise, the preceding dose level, if any, would be declared the MTD. The MTD would be used for the Phase II arm. At a given dose, the probability of halting dose escalation when the true toxicity is 50% or higher is at least 66% (power). In addition, if the true DLT rate is instead 20%, there will still be a 10% probability of halting dose escalation at a given dose level (type I error).~Rating scale: 0 = not the MTD, 1 = MTD"|Start of treatment to 90 days|The first six eligible patients who started protocol treatment at each dose level.||units on a scale|||Number
177094|NCT00046475|Primary|Post-treatment OHSA Item 1 Score of US Participants With Marked/Severe Disease According to The CGI-S Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. The results are reported by degree of severity according to the CGI-S scale, which uses 4 categories to describe disease severity: Mild, Moderate, Marked, and Severe. The Item 1 scores reported are grouped for participants with Marked or Severe disease severity. Higher scores indicate more severe disease.|End of 2-week treatment period|Randomized participants enrolled at any of the 28 US sites||scores on a scale||Standard Deviation|Mean
177095|NCT00046475|Primary|Post-treatment OHSA Item 1 Score of United States (US) Participants With Mild/Moderate Disease According to The Clinical Global Impressions-Severity (CGI-S) Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. The results are reported by degree of severity according to the CGI-S scale, which uses 4 categories to describe disease severity: Mild, Moderate, Marked, and Severe. The Item 1 scores reported are grouped for participants with Mild or Moderate disease severity. Higher scores indicate more severe disease.|End of 2-week treatment period|Randomized participants enrolled at any of the 28 US sites||scores on a scale||Standard Deviation|Mean
177096|NCT00046475|Secondary|Convergent Validity of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA and the OHSA composite score were analyzed for convergent validity with the CGI-I-Clinician scores. The change from baseline in the CGI-I scores are correlated with the OHSA Item 1 score change from baseline and the OHSA composite score change from baseline for the subjects in the ITT population. Values shown are Spearman correlation coefficients.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||correlation coefficient|||Number
177119|NCT00046228|Primary|The Composite of All-Cause Mortality or Complications of MI at 90 Days.|Occurs within 90 days and is composite of all-cause mortality or complications of myocardial infarction (MI) (rehospitalization or emergency department visit for congestive heart failure (CHF), cardiogenic shock, or resuscitated ventricular fibrillation occurring > 48 hours after randomization).|90 days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all subjects randomly assigned to a treatment group and classified according to the randomization assignment.||participants|||Number
177097|NCT00046475|Secondary|Responsiveness of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA, the OHSA composite score, and the OHDAS global daily activity score were analyzed for responsiveness as a measure of validity. Assuming that subjects who received Placebo during Randomization Period 1 are stable between Visit 3A and Visit 5, and using them as the stable subjects, responsiveness was calculated as [(OH CFB in Midodrine group)-(OH CFB in Placebo group)]/(SD of OH CFB in Placebo group), where CFB is change from baseline, SD is the standard deviation of OH CFB of the stable subjects; the value reported is the quotient of this equation.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||quotient|||Number
177098|NCT00046475|Secondary|Test Reliability of the Intent-to-Treat (ITT) Population|Item 1 of the OHSA, the OHSA composite score, and the OHDAS global daily activity score were analyzed for test-retest reliability as a measure of validity. Test-retest reliability is the Pearson product-moment correlation coefficient calculated between OHQ scores at Visit 3A (baseline measure) and OHQ scores at Visit 5 for the subjects who received Placebo during Randomization Period 1.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||correlation coefficient|||Number
177099|NCT00046475|Secondary|Change From Baseline in Short Form-36 (SF-36) Version 2 Health Survey Questionnaire Scores|"The SF-36 consists of 36 items in eight domains: physical functioning, general health, role-physical, bodily pain, vitality, social functioning, role-emotional, and mental health. Version 2 references one week ago for some questions. Raw scale scores for the SF-36 were transformed to a 0-100 scale with a higher score indicating a better quality of life. A positive change from baseline indicates that symptoms have improved. The SF-36 was completed at Visit 5 (Period 2) and Visit 6 (study completion) and compared to the score from Visit 3A (titration)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
177100|NCT00046475|Secondary|Change From Baseline in Supine BP|Supine BP was measured at Visit 5 (Period 2) and Visit 6 (study completion) and compared to measurements taken at Visit 3A (titration). Supine BP was measured after the patient had been in the supine position for 5 minutes.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||mmHg||Standard Deviation|Mean
177101|NCT00046475|Secondary|Change From Baseline in Standing Blood Pressure (BP)|Standing BP was measured at Visit 5 (Period 2) and Visit 6 (study completion) and compared to measurements taken at Visit 3A (titration). Standing BP was measured 3 minutes after the patient rose from the supine position or as soon as the patient indicated they needed to sit down. If the patient indicated he or she needed to sit down, the BP measurement was taken while in the standing position, before the patient sat down.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||mmHg||Standard Deviation|Mean
177102|NCT00046475|Secondary|Percent of Participants Scored as Improved on The Patient Version of The CGI-I Scale|"The CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Clinical Global Impressions ratings are completed with respect to neurogenic OH symptoms. A value of 0 was used if the investigator or patient assessment was not performed. The improved category is made up of patients who were evaluated as very much improved, much improved, or slightly improved for the classification of Overall Improvement. The CGI-I was completed at Visit 5 (Period 2) and Visit 6 (study completion)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||percent of participants|||Number
177103|NCT00046475|Secondary|Percent of Participants Scored as Improved on The Clinician Version of The Clinical Global Impressions Improvement (CGI-I) Scale|"The CGI-I is a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Clinical Global Impressions ratings are completed with respect to neurogenic OH symptoms. A value of 0 was used if the investigator or patient assessment was not performed. The improved category is made up of patients who were evaluated as very much improved, much improved, or slightly improved for the classification of Overall Improvement. The CGI-I was completed at Visit 5 (Period 2) and Visit 6 (study completion)."|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||percent of participants|||Number
177104|NCT00046475|Secondary|Change From Baseline in The Orthostatic Hypotension Global Daily Activity Score|The OHDAS global daily activity score was calculated as the average of all daily activity item scores. The OHDAS had 4 items that asked the patient to give a graduated score from 0 (no limitation due to OH) to 10 (complete limitation due to OH) to activities that required standing for a short time, standing for a long time, walking for a short time, walking for a long time. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
177105|NCT00046475|Secondary|Change From Baseline in The Orthostatic Hypotension Daily Activity Scale (OHDAS) Items 1 Through 4 Scores|The OHDAS had 4 items that asked the patient to give a graduated score from 0 (no limitation due to OH) to 10 (complete limitation due to OH). Item 1 addressed activities that required standing for a short time; Item 2, activities that required standing for a long time; Item 3, activities that required walking for a short time; and Item 4, activities that required walking for a long time. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
177741|NCT00008385|Primary|Incidence Rate of Second Primary Lung Tumor|Incidence rate of second primary lung tumor was defined as the number of new second primary lung tumors per 100 population at risk in a year.|Assessed annually for 10 years after randomization|all randomized patients||cases/100 person years|||Number
177106|NCT00046475|Secondary|Change From Baseline in The OHSA Composite Symptom Score|The OHSA composite symptom score was calculated by taking the average of the ratings for the symptoms present at Baseline. Participants were asked to rate symptoms by using a 0-10 scale (0 meaning not bothered and 10 meaning the worst). For subsequent visits, only those symptoms present at Baseline were scored. In this manner, a score was produced that represents the severity (and subsequent change in severity) of the patient's neurogenic OH symptoms, regardless of how many symptoms are presented at Baseline. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
177107|NCT00046475|Secondary|Change From Baseline in The OHSA Items 2 Through 6 Scores|Items 2 through 6 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of the following symptoms whenever he or she was standing and that improved when he or she sat down or laid down: Item 2 addresses problems with vision (blurring, seeing spots, tunnel vision, etc); Item 3, weakness; Item 4, fatigue; Item 5, trouble concentrating; and Item 6, head or neck discomfort. Symptomatology was assessed at Visit 3A (titration), Visit 5 (Period 2), and Visit 6 (study completion). A negative change from baseline indicates that symptoms have improved.|From the time of titration until the end of treatment|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
177108|NCT00046475|Primary|Re-analysis of The Post-treatment Score For Item 1 of The OHSA Scale, Excluding Two Sites|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. Higher scores indicate more severe disease.|End of 2-week treatment period|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement. Data for 2 sites were excluded from this re-analysis.||scores on a scale||Standard Deviation|Mean
177109|NCT00046475|Primary|Post-treatment Score For Item 1 of The Orthostatic Hypotension Symptom Assessment (OHSA) Scale|Item 1 of the OHSA asked the patient to rate, using a 0-10 scale (0 meaning not bothered and 10 meaning the worst), his or her impression of the severity of dizziness, lightheadedness, feeling faint, or feeling like you might black out whenever he or she was standing and that improved when he or she sat or laid down. Higher scores indicate more severe disease.|End of 2-week treatment period|Intent-to-Treat, defined as all patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.||scores on a scale||Standard Deviation|Mean
177110|NCT00046228|Other Pre-specified|Subjects With Pre-Specified Complications of Index Myocardial Infarction Through Discharge/Day 7|Number of subjects with one or more of the following: 2nd or 3rd Degree AVB, Asystole, Sustained V Tach, A Fib/Flutter, EMD/Pulseless Electrical Activity, Heart Failure, Tamponade, Myocardial Rupture, Papillary Muscle Rupture, Ventricular Septal Defect, Pulmonary Embolism, Systemic Arterial Embolism and/or Pericarditis/Pericardial Effusion.|Discharge/Day 7|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.||participants|||Number
177111|NCT00046228|Other Pre-specified|Subjects With Any Investigator Reported Bleeding Events Through Discharge/Day 7||Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.||participants|||Number
177112|NCT00046228|Other Pre-specified|Subjects With Severe Thrombocytopenia Through Discharge/Day 7|Severe thrombocytopenia is defined as platelet count < 50,000 cells/μL.|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.||participants|||Number
177113|NCT00046228|Other Pre-specified|Subjects With Non Intracranial Thrombolysis In Myocardial Infarction (TIMI) Bleeding Events Through Discharge/Day 7|Subjects with nonintracranial TIMI bleeding (either major or minor) through discharge/day 7, originating from vascular instrumentation sites, non-instrument related bleeding, as well as overall, were examined.|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.||participant|||Number
177114|NCT00046228|Other Pre-specified|Subjects With Intracranial Hemorrhage (Including Hemorrhagic Transformation) Through Discharge/Day 7|All cases of cerebrovascular event were confirmed by a CEC (Clinical Endpoints Committee).|Discharge/Day 7|The population was defined as all subjects who were randomized and treated with any study agent, including those who discontinued for any reasons. Subjects randomized and treated was classified according to the study drug(s) received.||participants|||Number
177115|NCT00046228|Secondary|All-Cause Mortality Through 1 Year|All-cause mortality through 1 year from randomization.|1 year|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.||participants|||Number
177116|NCT00046228|Secondary|Subjects With ST-Segment Resolution > 70% From Baseline at 60 to 90 Minutes Following Randomization||60 to 90 minutes|Population is the intent-to-treat subjects who were selected for evaluation by electrocardiogram (ECG) core laboratory.Subjects, who were not evaluable for a 60-90 minute ECG, were considered not having a ST segment resolution.||participants|||Number
177117|NCT00046228|Secondary|All-Cause Mortality Through 90 Days|All cause mortality occurred through 90 days from randomization.|90 days|Population is the intent-to-treat subjects. The intent-to-treat population is defined as all randomized subjects classified according to the randomization assignment.||participants|||Number
177162|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Standard Error|Least Squares Mean
177120|NCT00045630|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
177121|NCT00045630|Secondary|Overall Survival (OS)|Overall survival is defined from the date of registration to date of death from any cause|0-2 years|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
177122|NCT00045630|Primary|Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy|Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.|up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )|All eligible patients who started treatment were included in the analysis||percentage of participants||95% Confidence Interval|Number
177123|NCT00045487|Primary|Number of Patients With Ani-tumor Activity After Taking OSI-774.|Antitumor activity is measured with conventional techniques such as CT, MRI or X-ray. Scans are done at baseline then evaluated for response every 2 months. All tumor measurements must be recorded millimeters (or decimal fractions of centimeters).|Disease progression or 52 weeks duration|Intent to treat analysis.||participants|||Number
177124|NCT00045305|Secondary|Time to Engraftment for Platelet|Time to platelet engraftment is defined from date of infusion to date of platelet engraftment. The platelet engraftment is defined as platelets > 20,000 on two consecutive measurements, at least seven days apart, without platelet transfusions in between and for at least three days before the first measurement that is over 20,000. The date of engraftment is the date of the first measurement that is over 20,000.|Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.|eligible and treated patients||days||95% Confidence Interval|Median
177125|NCT00045305|Secondary|Time to Engraftment for Neutrophil|Time to neutrophil engraftment is defined from date of infusion to date of neutrophil engraftment. Neutrophil engraftment is defined as ANC > 500/mm3 on two consecutive measurements. The date of engraftment is the date of the first ANC > 500/mm3.|Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.|eligible and treated patients||days||95% Confidence Interval|Median
177126|NCT00045305|Secondary|Proportion of Graft Versus Host Disease|Proportion of Graft versus Host Disease is calculated as number of patients with Graft versus Host Disease divided by all eligible and treated patients|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients||proportion of participants||95% Confidence Interval|Number
177127|NCT00045305|Secondary|Overall Survival|Overall survival (OS) is defined to be the time from registration to death from any cause, with follow-up censored at the date of last contact. Kaplan-Meier method was used to estimate the distribution of OS.|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients||years||95% Confidence Interval|Median
177128|NCT00045305|Secondary|Number of Patients Who Developed Disease Progression After Achieving Complete Response|Disease free survival (DFS) was listed as a secondary endpoint in the study protocol, which would be assessed in patients who achieved complete response (CR). It was defined to be time from CR to documented progression or to death without progression. Patients without documented progression or death reported were censored at the time of last disease evaluation. However, due to the small number of patients with CR, the number of patients who developed disease progression was reported here.|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients who achieved complete response||participants|||Number
177129|NCT00045305|Primary|Complete Response Rate|"Completed response is defined as:~Bone marrow evaluation: Repeat bone marrow showing < 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia (see dysplasia qualifier under peripheral blood evaluation).~Peripheral blood evaluation [absolute values must last at least 2 months] Hemoglobin >11 g/dl (untransfused, not on erythropoietin) Neutrophils (1500/mm3 (not on a myeloid growth factor)) Platelets (100,000/mm3 (not on a thrombopoetic agent)) Blasts - 0% No dysplasia. No detectable cytogenetic abnormality, if preexisting abnormality was present"|Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.|eligible and treated patients||percentage of participants||90% Confidence Interval|Number
177130|NCT00045162|Secondary|Number of Patients With a Given Type and Grade of Adverse Event.|Only adverse events that are possibly, probably or definitely related to study drug are reported. Only patients who received protocol treatment and were assessed for adverse events are included.|Every 4 weeks while subject on protocol treatment for a maximum of 12 weeks.|Eligible patients who received protocol treatment.||Participants|||Number
177131|NCT00045162|Secondary|Confirmed and Unconfirmed Complete and Partial Responses.|Patients underwent chest CT/MRI every 6 weeks while on treatment and tumor response was evaluated by RECIST in the subset of patients with at least one target lesion at baseline. A target lesion was defined as a lesion with a longest diameter of at least 2 cm ( or at least 1 cm if by spiral CT). A complete response (CR) was defined as the disappearance of all disease, including non-target lesions. A partial response (PR) was defined as a 30% or greater decrease in the sum of the longest diameters. Confirmation of a CR or PR was defined as a second determination of CR or PR at least 4 weeks after the first determination.|Every 6 weeks while on protocol treatment for a maximum of 12 weeks|||participants|||Number
177751|NCT00007345|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|147 months and 5 days|||participants|||Number
177132|NCT00045162|Secondary|Progression-free Survival|Progression-Free Survival was defined as the duration from the date of randomization (enrollment) until the date of documentation of progression as defined by RECIST (a 20% increase over nadir in the sum of longest diameters of target lesions, clear progression of a non-target lesion in the opinion of the treating investigator, appearance of new lesions, or symptomatic deterioration) or death due to any cause. Patients last known to be alive and without evidence of progression were censored at the date of last contact.|Every 6 weeks until disease progression or a maximum of 3 years from the date of enrollment.|||months||95% Confidence Interval|Median
177133|NCT00045162|Primary|Overall Survival|Overall survival was defined as the duration between the date of randomization( enrollment) and the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.|Weekly while on treatment, then every 3 months for first year, then every 6 months unitl a maximum of 3 years from enrollment.|||Months||95% Confidence Interval|Median
177134|NCT00044655|Secondary|Psychiatric Symptoms, Hospitalization, and Medication Side Effects||Measured at Year 1||||||
177135|NCT00044655|Primary|Number Who Discontinued Medication Within First 6 Study Months||Measured at Six Months|intent to treat samples for 2 substudies: injectable to injectable and polypharmacy to monotherapy||participants|||Number
177136|NCT00044512|Secondary|Overall Survival|Time from the first date of receiving study medication to death.|Start of treatment to death|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||95% Confidence Interval|Median
177137|NCT00044512|Secondary|Duration of Minor Response|Time from the date that MR was first documented to the date that PD was first documented.|Time from MR to PD|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||Full Range|Mean
177138|NCT00044512|Secondary|Time to Minor Response|Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||95% Confidence Interval|Median
177139|NCT00044512|Secondary|Duration of Stable Disease|Time from the first day of receiving study drug until there was a documented PD or response.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||95% Confidence Interval|Median
177140|NCT00044512|Secondary|Time to Progression|Time from the first date of receiving study drug until the first documented PD.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||95% Confidence Interval|Median
177141|NCT00044512|Secondary|Time to Response|Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups such as baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and hepatitis C status (positive vs negative).||days||95% Confidence Interval|Median
177142|NCT00044512|Secondary|Duration of Response|Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.|up to 3 years later|Intention to Treat (ITT) analyses were performed on all treated subjects and for subgroups baseline Child Pugh status (A vs B), ECOG PS (0 vs 1), TNM stage at study entry (II/III vs IV), hepatitis B and C status (positive vs negative). The 3 subjects are censored at time of evaluation. The Median is not estimable so the reported number is biased.||days||Full Range|Median
177143|NCT00044512|Primary|Percentage of Participants for Each Type of Response|Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.|Until 30 days after termination of active therapy|Intention to Treat (ITT) analyses were performed on subgroups of patients categorized by baseline characteristics of ECOG Performance Status, Child Pugh status, TNM stage at study entry, prior surgical procedure, hepatitis A and B status, and age.||percentage of participants|||Number
177144|NCT00044213|Secondary|A Composite of Cardiovascular Death, Non-fatal Myocardial Infarction and Non-fatal Stroke.|Number of patients with events (composite of cardiovascular death, non-fatal MI, non-fatal stroke) Events were centrally adjudicated where available; otherwise site reported events were used.|Measured over a maximum 5-year follow-up period- 55 month median|||participants|||Number
177145|NCT00044213|Primary|A Composite of Total Mortality, Recurrent Myocardial Infarction, Stroke, Coronary Revascularization, and Hospitalization for Angina.|Number of patients with events (composite of death from any cause, MI, stroke, coronary revascularization or hospitalization for angina) Events were centrally adjudicated where available; otherwise site reported events were used.|Measured over a maximum 5-year follow-up period- 55 month median|||participants|||Number
177146|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores|The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.||units on scale||Standard Error|Least Squares Mean
177147|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores|The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.||units on a scale||Standard Error|Least Squares Mean
177148|NCT00044044|Secondary|Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores|The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.||units on a scale||Standard Error|Least Squares Mean
177149|NCT00044044|Primary|Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score|"The BPRS consists of 18 ordered categorical items (from not present to extremely severe, on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia."|Baseline and 6 weeks|Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.||units on a scale||Standard Error|Least Squares Mean
177150|NCT00044005|Primary|Number of Participants With Adverse Events|The primary objective of this 6-month open-label study was to evaluate the safety of 3 doses of lurasidone.|6-months|No formal hypothesis testing was performed. However,descriptive statistics were provided and data summarized. Safety analyses were conducted on the safety population, that included all subjects who had received at least 1 dose of open-label study medication.||participants|||Number
177151|NCT00043979|Secondary|Number of Participants With Acute and Chronic GVHD|Acute GVHD as by Modified Glucksberg Criteria occurring before day 100. Chronic GVHD as per Seattle criteria occurring after day 100.|up to 5 years or death|||participants|||Number
177152|NCT00043979|Primary|Toxicity|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|16.5 months|||Participants|||Number
177153|NCT00043979|Primary|Number of Participants With Engraftment|Engraftment is defined as rapid conversion to complete donor chimerism and is assessed by blood counts and chimerism, >95% donor engraftment at day 100 in >75% of patients.|100 days|"E.g ...in >75% of patients, shown above is not a conclusion but refers to a hypothesis, the objective of the protocol.~23 were analyzed because 7 donors were taken off study and stem cells not collected due to progressive disease of sibling."||Participants|||Number
177154|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 48|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Inter-Quartile Range|Median
177155|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 42|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Inter-Quartile Range|Median
177156|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 36|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Inter-Quartile Range|Median
177157|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 24|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Inter-Quartile Range|Median
177158|NCT00043186|Secondary|Bone Specific Alkaline Phosphatase Percent Change From Baseline at Month 12|Bone specific alkaline phosphatase (BSAP). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Inter-Quartile Range|Median
177159|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Standard Error|Least Squares Mean
177160|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Standard Error|Least Squares Mean
177161|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Standard Error|Least Squares Mean
177163|NCT00043186|Secondary|Total Body Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Standard Error|Least Squares Mean
177164|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing baseline and non-missing value at Month 48.||Percent change||Standard Error|Least Squares Mean
177165|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Standard Error|Least Squares Mean
177166|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Standard Error|Least Squares Mean
177167|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Standard Error|Least Squares Mean
177168|NCT00043186|Secondary|Distal 1/3 Radius Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Standard Error|Least Squares Mean
177169|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Standard Error|Least Squares Mean
177170|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Standard Error|Least Squares Mean
177171|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Standard Error|Least Squares Mean
177172|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Standard Error|Least Squares Mean
177173|NCT00043186|Secondary|Total Hip Bone Mineral Density Percent Change From Baseline at Month 12|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and 12 months|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Standard Error|Least Squares Mean
177174|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 48|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Inter-Quartile Range|Median
177175|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 42|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Inter-Quartile Range|Median
177176|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 36|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Inter-Quartile Range|Median
177177|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 24|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Inter-Quartile Range|Median
177178|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 48|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Inter-Quartile Range|Median
177179|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 42|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participantswith non-missing Baseline and non-missing value at Month 42.||Percent change||Inter-Quartile Range|Median
177182|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 48|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 48 calculated using ((Month 48 value - Baseline value) / Baseline value ) x 100.|Baseline and 48 months|Randomized participants with non-missing Baseline and non-missing value at Month 48.||Percent change||Standard Error|Least Squares Mean
177183|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 42|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 42 calculated using ((Month 42 value - Baseline value) / Baseline value ) x 100.|Baseline and 42 months|Randomized participants with non-missing Baseline and non-missing value at Month 42.||Percent change||Standard Error|Least Squares Mean
177184|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 36|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 36 calculated using ((Month 36 value - Baseline value) / Baseline value ) x 100.|Baseline and 36 months|Randomized participants with non-missing Baseline and non-missing value at Month 36.||Percent change||Standard Error|Least Squares Mean
177185|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 24|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 24 calculated using ((Month 24 value - Baseline value) / Baseline value ) x 100.|Baseline and 24 months|Randomized participants with non-missing Baseline and non-missing value at Month 24.||Percent change||Standard Error|Least Squares Mean
177186|NCT00043186|Secondary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Alendronate Arm|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Standard Error|Least Squares Mean
177187|NCT00043186|Secondary|Urine NTX/Creatinine Percent Change From Baseline at Month 12|Urinary N-telopeptide (uNTX)/Creatinine. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Inter-Quartile Range|Median
177188|NCT00043186|Secondary|Serum CTX Percent Change From Baseline at Month 12|Serum C-Telopeptide (CTX). Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12||Percent change||Inter-Quartile Range|Median
177189|NCT00043186|Primary|Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 for the Placebo and Denosumab Arms|Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change from Baseline to Month 12 calculated using ((Month 12 value - Baseline value) / Baseline value ) x 100.|Baseline and Month 12|Randomized participants with non-missing Baseline and non-missing value at Month 12.||Percent change||Standard Error|Least Squares Mean
177190|NCT00042991|Secondary|Number of Patients With Epidermal Growth Factor Receptor (EGFR) Amplification|Epidermal growth factor receptor (EFGR) is a protein found on the surface of cells to which epidermal growth factor (EGF) binds. When EGF attaches to EGFR, it activates the enzyme tyrosine kinase, triggering reactions that cause the cells to grow and multiply.|Pre-treatment|Epidermal growth factor receptor is only possible with tumor sample, which is only potentially available from supratentorial malignant glioma patients treated on Stratum-1B and Stratum-2. Of 10 Stratum-1B and 3 Stratum-2 patients (n=13), tumor material was available from 11 patients (8 in Stratum-1A and 3 in Stratum-2).||Participants|||Number
177191|NCT00042991|Secondary|Gefitinib Area Under the Concentration Curve From 0-24 Hours (AUC)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.||mcg/L*hr||Full Range|Median
177192|NCT00042991|Secondary|Time of Maximum Clearance of Gefitinib (Tmax)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.||Hour||Full Range|Median
177193|NCT00042991|Secondary|Clearance of Gefitinib (Cl)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.||L/hr/m2||Full Range|Median
177194|NCT00042991|Secondary|Elimination Half Life of Gefitinib (t1/2)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.||hour||Full Range|Median
177195|NCT00042991|Secondary|Peak Serum Concentration of Gefitinib (Cmax)||Week 2 of course 1|PK Data was combined at each dose level accross strata (Stratum 1A, Stratum 1B, and Stratum 2); at Dose 250 mg/m^2 of Gefitinib accross strata, PK data from Phase-I patients was analysed earlier for the publication of the Phase-I trial. PK data for the Phase-II patients was analyzed separately for the Phase-II publication.||mcg/ml||Full Range|Median
177196|NCT00042991|Secondary|Mean Tumor to White Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal white matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to white matter ratio value and the median of these values across patients is reported.|Baseline|Out of 43 patients, only 18 Patients had baseline PET scans. Therefore, this analysis is based on these 18 patients.||Ratio||Full Range|Median
177197|NCT00042991|Secondary|Mean Tumor to Gray Matter Ratio Measured at Baseline|This study attempts to characterize neuroimaging parameters from positron emission tomography. For each patient, the axial image through the tumor containing the maximum activity per pixel corresponding to the highest FluoroDeoxyGlucose (FDG) uptake was identified and a region of interest (ROI) was drawn based on the FDG definition of the tumor. The mean pixel values within the tumor ROI were normalized by those for normal gray matter to provide ratios of tumor/gray matter. Each patient has a mean tumor to gray matter ratio value and the median of these values across patients is reported.|Baseline|Out of 43 patients, only 18 Patients had baseline PET scans. Therefore, this analysis is based on these 18 patients.||Ratio||Full Range|Median
177198|NCT00042991|Secondary|Change From Baseline in Perfusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Perfusion ratio is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, 20 patients had perfusion scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 20 patients.||Ratio||Full Range|Median
177199|NCT00042991|Secondary|Change From Baseline in Diffusion Ratio at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Diffusion ratio is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, 29 patients had diffusion scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 29 patients.||Ratio||Full Range|Median
177200|NCT00042991|Secondary|Change From Baseline in Volume Enhancing at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. Neuroimaging changes may have some association with outcome (response,survival, etc.). Volume enhancing is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain.|Baseline and two weeks post completion of radiation|Out of 43 patients, for only 19 patients, enhacing tumor was greater than zero based on brain MRI scans before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the enhancing volumetric data from these 19 patients.||cc||Full Range|Median
177201|NCT00042991|Secondary|Change in Tumor Volume Measured on Fluid Attenuated Inversion Recovery (FLAIR) Imaging at Before the Protocol Therapy Started and at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of treatment on changes in various neuroimaging variables. In this particular objective, the study aimed to investigate how radiation+gefitinib affect the tumor volume. Tumor volume is measured using Fluid Attenuated Inversion Recovery (FLAIR) before and after the radiation therapy.|Baseline and two weeks post completion of radiation|Out of 43 patients, 35 patients had brain MRI before the treatment started and at the time of the completion of Radiation therapy. Therefore, this analysis is based on the volumetric data from these 35 patients.||cc||Full Range|Median
177202|NCT00042991|Primary|Median Survival in Newly Diagnosed Brain Stem Gliomas|Overall survival is defined as the interval from initiation of treatment to death or date of last contact for surviving patients|Assessed from the start of therapy until three years after initiation of gefitinib therapy|||Months||Full Range|Median
177203|NCT00042991|Primary|Median Progression-free Survival in Newly Diagnosed Brain Stem Gliomas|Progression-free survival is defined as the interval from intiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurlogical status) or death for patients who failed or to the last date of follow-up for patients without failure|Assessed pre-radiation, every 8 weeks for 13 courses of therapy, and then every 12 weeks|Here, we only report the results for Phase-II trial as this objective was specifically for the Phase-II trial. This cohort includes seven patients who were treated during Phase-I at Dose 250 mg/m^2 of Gefitinib.||Months||Full Range|Median
177204|NCT00042991|Primary|Number of Participants in Phase I Stratum 1A With Dose-limiting Toxicities (DLT) Observed During the First 8 Weeks of Gefitinib Therapy|The dose limiting toxicity (DLT) analysis population consists of stratum 1A phase I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD based on the tradional 3+3 design, where a dose is considered a safe dose only when 0 out of 3, or at most 1 out of 6 patients has DLTs. When two or more patients in a group of 2 to 6 patients had DLTs, then that dose level was considered to be too toxic.|Day 1 of gefitinib therapy to end of week 8|This cohort includes only the patients who were enrolled and treated on Gefitinib+Radiation during the Phase I component of the trial, where the safety of Gefitinib was assedded at Dose Levels 100 mg/m^2, 250 mg/m^2, and 375 mg/m^2.||Participants|||Number
177205|NCT00042939|Secondary|Proportion of Patients With Thromboembolic Events|To determine the rate of thromboembolic events in this population when prophylactic enoxaparin sodium is administered.|Assessed every 6 weeks while on treatment and for 30 days after the end of treatment|Eligible and treated patients||Proportion of participants||90% Confidence Interval|Number
177206|NCT00042939|Secondary|Epidermal Growth Factor Receptor (EGFR) Status|EGFR expression was be evaluated by staining 5-micron paraffin sections of tumor biopsies with anti-EGFR clone 2-18C9 (DAKO Corporation, Carpinteria, CA) using an indirect immunoperoxidase technique according to the instructions provided by DAKO. In brief, this includes an antigen retrieval pretreatment, the blocking of endogenous peroxidase activity, incubation with anti-EGFR antibody or a negative reagent control, staining with a detection system, visualization, and coverslipping.|Original tumor tissue samples submitted within one month of patient randomization|Eligible and treated patients with EGFR stain results available.||participants|||Number
177207|NCT00042939|Secondary|Overall Survival|Overall survival was defined as time from registration to death from any cause.|Assessed every 3 months for 2 years and then every 6 months for 1 year|Eligible patients who began treatment.||months||90% Confidence Interval|Median
177208|NCT00042939|Secondary|Progression-free Survival|"Progression-free survival was defined as the shorter of:~The time from registration to progression. or~The time from registration to death without documentation of progression given that the death occured within 4 months of the last disease assessment without progression (or registration, whichever is more recent).~Progression is defined as at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing nontarget lesions."|Assessed every 3 months for 2 years and then every 6 months for 1 year|Eligible patients who began treatment.||months||90% Confidence Interval|Median
177209|NCT00042939|Primary|Proportion of Patients With Objective Response Evaluated by RECIST (Solid Tumor Response Criteria)|"Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.~Objective response = CR + PR"|Assessed every 12 weeks until progression|Eligible patients who began treatment were included in the analysis.||Proportion of participants||90% Confidence Interval|Number
177210|NCT00041938|Other Pre-specified|Rate Per 100 Patient-years of Minor Hemorrhage.|Rate per 100 patient years of minor hemorrhage. Includes all minor hemorrhages. Minor hemorrhage was defined as any non-major hemorrhage. Event rate per 100 patient years = 100*(number of minor hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.|From date of randomization until the end of scheduled follow-up, up to 6 years|Intent-to-treat||events per 100 patient-years|||Number
177211|NCT00041938|Other Pre-specified|Rate Per 100 Patient Years of Major Hemorrhage|Rate/100 patient-years of major hemorrhage. Includes all major hemorrhages in any patient. Major hemorrhage was defined as intracerebral, epidural, subdural, subarachnoid, spinal intramedullary, or retinal hemorrhage; any other bleeding causing a decline in the hemoglobin level of more than 2 g per deciliter in 48 hours; or bleeding requiring transfusion of 2 or more units of whole blood, hospitalization, or surgical intervention. Event rate per 100 patient years = 100*(number of major hemorrhage events)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization until end of scheduled follow-up, up to 6 years|Intent-to-treat||events per 100 patient years|||Number
177212|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Death Component of Secondary Composite Outcome|Time, in years, from randomization to death component of secondary composite outcome. This measure counts only deaths that were not preceded by heart failure hospitalization, myocardial infarction, ischemic stroke, or intracerebral hemorrhage. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of death component of secondary composite outcome, up to 6 years|Intent-to-treat||events per 100 patient years|||Number
177213|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Intracerebral Hemorrhage Component of Secondary Composite Outcome|Time, in years, from date of randomization to date of intracerebral hemorrhage component of secondary composite outcome. Includes only intracerebral hemorrhages not preceded by myocardial infarction or heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of intracerebral hemorrhage component of secondary composite outcome, up to 6 years|Intent-to-treat||events per 100 patient years|||Number
177214|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Ischemic Stroke Component of Secondary Composite Outcome|Ischemic stroke component of secondary composite endpoint. Includes only ischemic strokes that were not preceded by a myocardial infarction or heart failure hospitalization. The number of ischemic strokes that are components of the secondary outcome does not therefore match the number of ischemic strokes that are components of the primary outcome. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1)of all randomized patients / 365.25.|From date of randomization to date of ischemic stroke component of secondary composite outcome, up to 6 years|Intent-to-treat.||events per 100 patient years|||Number
177215|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Heart Failure Hospitalization Component of Secondary Composite Outcome.|Time, in years, from date of randomization to date of heart failure hospitalization, up to 6 years. Includes hospitalizations for heart failure during follow-up that were not preceded by myocardial infarction. Event rate per 100 patient years = 100*(number of subjects with heart failure hospitalization)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of heart failure hospitalization component of secondary composite outcome, up to 6 years|Intent-to-treat.||events per 100 patient years|||Number
177216|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient Years of Myocardial Infarction Component of Secondary Composite Outcome|Time, in years, from date of randomization to date of myocardial infarction, up to 6 years. Includes only myocardial infarctions that occurred during follow-up, before any heart failure hospitalization. Event rate per 100 patient years = 100*(number of subjects with myocardial infarction)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of myocardial infarction component of secondary composite outcome, up to 6 years|Intent-to-treat||events per 100 patient years|||Number
177217|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Death|Time, in years, from date of randomization to date of death component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects who died)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of death component of primary composite outcome, up to 6 years|Intent-to-treat||events per 100 patient-years|||Number
177218|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Intracerebral Hemorrhage|Time, in years, from date of randomization to date of intracerebral hemorrhage component of primary composite outcome. Event rate per 100 patient years = 100*(number of subjects with intracerebral hemorrhage)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of intracerebral hemorrhage component of primary composite outcome, up to 6 years|Intent-to-treat||rate per 100 patient years|||Number
177219|NCT00041938|Other Pre-specified|Event Rate Per 100 Patient-years for Ischemic Stroke|Time, in years, from date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years. Event rate per 100 patient years = 100*(number of subjects with ischemic stroke)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization to date of ischemic stroke component of primary composite outcome, up to 6 years|Intent-to-treat||rate per 100 patient years|||Number
177220|NCT00041938|Secondary|Event Rate Per 100 Patient-years for Composite Endpoint of Hospitalization for Heart Failure, Myocardial Infarction, Ischemic Stroke, Intracerebral Hemorrhage, or Death.|"The time, in years, from date of randomization to the date of the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to 6 years.~Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25."|From randomization to the first to occur of hospitalization for heart failure, myocardial infarction, ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years.|Intent-to-treat analysis: all enrolled patients were analyzed.||events per 100 patient-years|||Number
177221|NCT00041938|Primary|Event Rate Per 100 Patient Years for Composite Endpoint of Ischemic Stroke, Intracerebral Hemorrhage, or Death|The time, in years, from randomization to the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to a maximum of 6 years. Event rate per 100 patient years = 100*(number of subjects with event)/patient-years of follow-up. Patient years of follow-up = sum(date of conclusion of follow-up - date of randomization + 1) of all randomized patients / 365.25.|From date of randomization until the date of the first to occur of ischemic stroke, intracerebral hemorrhage, or death, up to 6 years|Intent-to-treat analysis: all enrolled patients were analyzed.||events per 100 patient-years|||Number
177222|NCT00041080|Primary|Median Progression-free Survival||from enrollment onto the study until first disease progression or death due to any cause|||months||95% Confidence Interval|Median
177223|NCT00041067|Secondary|Toxicity|Number of patients for whom highest grade of toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.|toxicities assessed every 3 weeks during treatment, for up to 3 years if no progession|Eligible patients||Participants|||Number
177224|NCT00041067|Secondary|Progression-free Survival||2 years|All eligible patients||months||95% Confidence Interval|Median
177225|NCT00041067|Secondary|Response Rate (Complete and Partial, Confirmed and Unconfirmed)|Response was measured by the RECIST criteria. A patient was considered a responder if there was confirmed or unconfirmed partial or complete response. All others were considered non-responders even if the patient was technically not assessable due to different measurement techniques at the two time points.|response assessed after every 3 cycles (9 weeks) during treatment for up to 3 years if no progession|patients with Response Evaluation Criteria in Solid Tumors measurable disease||participants|||Number
177226|NCT00041067|Primary|Survival at 1 Year||1 year|All eligible patients||percentage of patients||95% Confidence Interval|Number
177227|NCT00040937|Primary|Overall Survival||4-7 years|||proportion surviving at 4 years||95% Confidence Interval|Number
177228|NCT00040937|Secondary|Assess Toxicity of Thalidomide/Dexamethasone as a Pre-transplant Induction Regimen.|To assess Grade 3-5 AE related to thalidomide/dexamethasone when administered as a pre-transplant induction regimen.|Induction|All participants receiving at least one dose of induction therapy||Participants|||Number
177229|NCT00042432|Secondary|Percentage Change From Baseline in Mean iPTH During the Efficacy Assessment Phase|Percentage change from baseline in mean intact parathyroid hormone (iPTH) during the efficacy assessment phase|Baseline, efficacy assessment phase (weeks 12-18)|All randomized participants, using Last Value Carried Forward (LVCF) imputation||Percent change||Standard Error|Mean
177230|NCT00042432|Primary|Reduction in Mean iPTH of ≥ 30% During the Efficacy Assessment Phase|Reduction in mean intact parathyroid hormone (iPTH) of ≥ 30% within the participant during the efficacy assessment phase|Efficacy assessment phase (weeks 12-18)|All randomized participants, using Last Value Carried Forward (LVCF) imputation||Participants|||Number
177231|NCT00042224|Primary|Response Rates in the ECT Plus Clozapine Group vs the Pharmacotherapy Group.|Response is defined as 40% reduction of symptoms in the psychotic symptom sub-scale (hallucinatory behavior, suspiciousness, conceptual disorganization, and unusual thought of content) of the Brief Psychiatric Rating Scale (BPRS) at the end of the 8-week study. BPRS assesses psychotic symptoms on a 18-item scale. The severity of each item is rated on a continuous scale from 1-7, with 1 being the least severe and 7 being most severe. Participants included in the study, at baseline had at least a moderate score of 4 on one of the four psychotic symptom sub-scale or a score of 12 on all four of these items combined. A reduction of symptoms would be a sub-scale score which is 40% less than participants baseline score. If a participant enters the study with a sub-scale score of 15, to be considered a responder (at least a 40% reduction in symptoms score) his/her score must decrease by at least 6 points and be 9 or less.|8 Weeks|inpatient units of the Zucker Hillside Hospital at Glen Oaks, N.Y., and the Pilgrim State Psychiatric Center in Long Island, N.Y.||Percentage of responders|||Number
177251|NCT00040664|Primary|Geometric Mean of Steady State Plasma Amprenavir (APV) Parameter: AUC(0-tau)|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. AUC(0-tau)=area under the concentration curve from time 0 to tau."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The Pharmacokinetic (PK) Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||hours*micrograms/milliliter||95% Confidence Interval|Geometric Mean
177232|NCT00041756|Primary|Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score at 1 Year|The symptomatic primary efficacy endpoint is the change in total WOMAC scores after 1 year of treatment. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical Function (17 items). The WOMAC uses descriptors for all items: none, mild moderate, severe, and extreme (corresponding to an ordinal scale of 0-4.) Scores are summed for items in each subscale, with possible ranges as follows: pain=0-20, stiffness=0-8, physical function=0-68. The total WOMAC score is created by summing the items for all three subscales (min=0, max=96)|baseline and 12 months|An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis.||Scores on a scale||Standard Error|Least Squares Mean
177233|NCT00041756|Primary|Change in Minimum Joint Space Width in the Medial Compartment of the Tibiofemoral Joint of the Signal Knee After 1 Year of Treatment|The structural primary efficacy endpoint is the 1-year change from baseline in minimum joint space width (JSW) in the medial compartment of the tibiofemoral joint of the signal knee, as measured by microfocal knee radiographs obtained in the semi-flexed position.|baseline and 12 months|"An intent-to-treat (ITT) analysis was conducted on all patients who were randomized and took at least one dose of study drug. Any missing data for these patients was not imputed in the primary analysis.~analysis."||mm||Standard Error|Least Squares Mean
177234|NCT00041717|Primary|Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment|This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.|Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98|ITT||units on a scale||Standard Error|Mean
177235|NCT00041717|Primary|Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity|The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.|Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98|Intent to treat (ITT) population||units on a scale||Standard Error|Mean
177236|NCT00041392|Primary|Cognitive Function|To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a factor analysis was performed on the cognitive test scores from baseline. We chose a four-factor solution, which represents 4 cognitive domains: verbal memory, abstraction and visuo-spatial orientation (executive function), visual memory and attention and concentration. To quantify overall cognitive function, a baseline cognitive index was first calculated as the mean of the 4 preoperative domain scores. The cognitive index score has a mean of zero and standard deviation of 0.5. Thus, any positive score is above the mean, any negative score is below the mean, and a score of 0.5 represents 1 SD above the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. Negative scores indicate decline and positive scores indicate improvement.|Measured at baseline and 6 weeks|||Continuous cognitive change score||Standard Deviation|Mean
177237|NCT00041132|Secondary|Overall Survival|Overall Survival rate at 1 year. Time to death is from date of registration to date of death due to any cause.|assessed after cycle 4, after completion of treatment, then every 3 months for 2 years, then every 6 months thereafter until 5 years|||percentage of participants||95% Confidence Interval|Number
177238|NCT00041132|Secondary|Response|Complete (CR), complete unconfirmed (CRU) and partial responses (PR). CR is complete disappearance of all measurable and non-measurable disease with the exception of nodes; no new lesions; previously enlarged organs must have regressed in size; and if bone marrow positive at baseline, it must be negative. CRU is complete disappearance of all measurable and non-measurable disease; regressed, non-palpable organs; and one or more exceptions not qualifying for CR (see protocol section 10). PR applies to patients with at least one measurable lesion who do not qualify for CR or CRU. PR is a 50% decrease in sum of products of greatest diameters (SPD) for up to six identified dominant lesions identified at baseline; no new lesions; no increase in the size of liver, spleen or other nodes; and splenic and hepatic nodules must have regressed in size by at least 50% in SPD.|assessed after cycle 4 and after completion of treatment (168 days)|||participants|||Number
177239|NCT00041132|Primary|Progression-free Survival|Progression-Free Survival (PFS) rate at 1 year. PFS measured from date of registration to date of first observation of progressive disease or death due to any cause. Progressive disease is a 50% increase in the sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed if a complete response (confirmed, or unconfirmed) was not previously achieved; appearance of a new lesion/site; unequivocal progression of non-measurable disease; or death due to disease without prior documentation of progression.|assessed after cycle 4, after completion of treatment, then every 3 months until 1 year after registration|||percentage of participants||95% Confidence Interval|Number
177240|NCT00040742|Secondary|Average Nausea Severity|"Nausea evaluated on a 7-point semantic rating scale anchored by 1 = Not at all nauseated and by 7 = Extremely nauseated. Acute nausea calculated as the average of the Day 1 Evening and Night nausea ratings.~Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of average acute nausea used as the outcome measure.~Negative values for this outcome are favorable."|3-4 days on study drug|Eligible patients 18 years of age or older, able to understand English, diagnosed with cancer, may have received more than one chemotherapy cycle and scheduled for at least three additional cycles; randomization stratified by CCOP site. A computer-generated random numbers table assigned patients to one of four treatment arms.||units on a scale||Standard Error|Mean
177241|NCT00040742|Primary|Change From Baseline of Peak Acute Nausea|"Nausea evaluated on a 7-point semantic rating scale anchored by 1 = Not at all nauseated and by 7 = Extremely nauseated. Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings.~Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure.~Negative values for this outcome are favorable."|3-4 days on study drug|Eligible patients 18 years of age or older, able to understand English, diagnosed with cancer, may have received more than one chemotherapy cycle and scheduled for at least three additional cycles; randomization stratified by CCOP site. A computer-generated random numbers table assigned patients to one of four treatment arms.||units on a scale||Standard Deviation|Mean
177242|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: Ctau|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||microgram per milliliter||95% Confidence Interval|Least Squares Mean
177243|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: Cmax|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4.|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||micrograms/milliliters||95% Confidence Interval|Least Squares Mean
177244|NCT00040664|Primary|Least Squares Mean of Plasma APV Parameter: AUC0-tau|A blood sample was drawn on Week 4 over 24 hours (at 0, 1, 2, 4, 8, 12, and 24 hours post dosing). Ratio of geometric least squares mean (90% CI) are presented. Ctau=trough concentration. PK Parameters for QD and BID are compared with Historical adult data. Least squares mean (LSM) are the group means after having controlled for a covariate (i.e., holding it constant at some typical value of the covariate, such as its mean value). LSM is calculated by taking the average of the means within a treatment.|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||hours*micrograms/milliliters||95% Confidence Interval|Least Squares Mean
177245|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: t1/2|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. t1/2=elimination half-life. t1/2=elimination half-life."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||hours||95% Confidence Interval|Geometric Mean
177246|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: CL/F|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. CL/F=apparent plasma clearance."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||milliliters/minute||95% Confidence Interval|Geometric Mean
177247|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: CL/F|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. CL/F=apparent plasma clearance."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||milliliters/minute/kilogram||95% Confidence Interval|Geometric Mean
177248|NCT00040664|Primary|Median Steady State Plasma APV Tmax|tmax: time after administration of the drug when maximum concentration is reached|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||hours||Full Range|Median
177249|NCT00040664|Secondary|Number of Participants With APV Resistance Associated HIV-1 RNA Genotypic Mutations and Phenotypic Resistance at Time of Virologic Failure Not Present at Baseline|A blood sample was drawn for participants failing to respond to therapy, and the mutations present in the virus were identified. For each participant, the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New mutations that developed at the time of virologic failure were tabulated by drug class. Virologic failure is defined as HIV-1 RNA greater than or equal to 400 copies/mL.|Time of virologic failure|Participants in the ITT-E Population who met the virologic failure definition. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.||Participants|||Number
177250|NCT00040664|Primary|Geometric Mean of Steady State Plasma APV Parameter: Cmax|"Geometric mean is a type of average that indicates the central tendency of a set of values and is calculated by multiplying all the numbers in a set, and then taking the nth root of the resulting product. Cmax= concentration maximum."|0, 1, 2, 4, 8, 12, and 24 hours post dosing at Week 4|The PK Parameter Population included all participants who underwent plasma PK sampling and provided full PK profiles with evaluable plasma APV PK parameter data; thus, the sample sizes were limited. Results are stratified by age cohort and formulation since these factors can impact PK profiles.||micrograms/milliliter||95% Confidence Interval|Geometric Mean
177265|NCT00039130|Secondary|2 Year Overall Survival|Percentage of participants who were alive at 2 years. The 2 year survival, with 95% confidence interval, was estimated using the Kaplan Meier method.|2 years|||percentage of participants||95% Confidence Interval|Number
177252|NCT00040664|Primary|Number of Participants With Grade 3 or 4 Treatment-emergent Laboratory Abnormalities|The number of participants with Grade 3 (severe) or Grade 4 (life-threatening) laboratory abnormalities while on study treatment.|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug||Participants|||Number
177253|NCT00040664|Primary|Number of Participants With Any Drug-related Grade 2 to 4 Adverse Event|The number of participants with drug-related adverse events coded as Grade 2 (mild), Grade 3 (severe), or Grade 4 (life-threatening).|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug||Participants|||Number
177254|NCT00040664|Secondary|Median Change From Baseline in CD4+ Values at Week 12, 48, 96, and 168 Visits|A blood sample was drawn to determine the CD4+ cell count at Weeks 24, 48, 96, and 168. Change from Baseline was defined as the CD4+ cell count at Weeks 24, 48, 96, and 168 minus the CD4+ cell count at Baseline.|Baseline and Weeks 12, 48, 96, and 168|ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.||Cells/mm3||Inter-Quartile Range|Median
177255|NCT00040664|Secondary|Median Change From Baseline HIV-1 RNA Values at Weeks 12, 48, 96, and 168 Visits|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies/mL at Weeks 12, 24, 48, 96, and 168. Change from Baseline was defined as the HIV-1 RNA level at Weeks 12, 24, 48, 96, and 168 minus the HIV-1 RNA level at Baseline.|Baseline and Weeks 12, 48, 96, and 168|ITT-E Population. Results are stratified by previous PI experience. Participants with previous PI experience may respond differently to FPV.||log10 copies/mL||Inter-Quartile Range|Median
177256|NCT00040664|Secondary|Percentage of Participants With HIV-1 RNA <400 Copies Per mL at Weeks 12, 48, 96, and 168 (Time to Loss of Virologic Response [TLOVR] Analysis)|A blood sample was drawn to determine the amount of HIV-1 RNA virus in copies per milliliter (mL) at Weeks 12, 48, 96, and 196. The percentage of participants with HIV-1 RNA <400 copies/mL at Weeks 12, 48, 96, 168 was determined by the TLOVR algorithm with stratification by the six randomization strata. TLOVR analysis categorizes participants by treatment response. Responders were participants with confirmed viral load <400copies/mL on two consecutive visits.|Weeks 12, 48, 96, and 168|The Intent-to-Treat Exposed (ITT [E]) Population consisted of all subjects with documented evidence of having received at least one dose of study drug. Results are stratified by previous protease inhibitor (PI) experience. Participants with previous PI experience may respond differently to FPV.||percentage of participants|||Number
177257|NCT00040664|Primary|Number of Participants Who Discontinued Treatment Due to Adverse Events|The number of participants who prematurely discontinued study drug due to adverse events was tabulated. Data are summarized by individual adverse event.|Baseline through end of study (at least Week 168)|Safety Population: all participants with documented evidence of having received at least one dose of study drug||Participants|||Number
177258|NCT00040365|Secondary|Number of Participants Who Had Proctoscopic Examinations|Proctoscopic scoring of mucosal change was performed according to a descriptive scale, described by Wachter et al, which assigns grades of mucosal congestion, telangiectasia, ulcerations, stricture, and necrosis.|3 years|||Participants|||Number
177259|NCT00040365|Secondary|Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)|Radiation toxicity consists of the Radiation Therapy Oncology Group(RTOG)acute(within 90 days of treatment)and RTOG late(>90days after treatment). This scoring system assigns a toxicity grade (0-4) based on symptoms with 0 being the best outcome. The Expanded Prostate Cancer Index Composite(EPIC) questionnaire consists of 50 quality of life items divided into 4 domains, urinary, bowel, sexual and hormonal. Each independent domain renders a scoring of 0-100 with 100 being the best score. The EPIC and RTOG scores were correlated not combined.|Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18|||scores on a scale||Full Range|Mean
177260|NCT00040365|Secondary|Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months)|The EPIC bowel assessment is a 26 item short form evaluation that assess patient function and bother after prostate treatment. The Expanded Prostate Cancer Index Composite is a self assessment questionnaire designed to measure quality of life in patients with prostate cancer. The questionnaire is scored on a scale of 0-100 with higher scores correlated with higher function and quality of life. For this study, the Bowel Domain was analyzed alongside the RTOG acute and late gastrointestinal morbidity scores. For details re: EPIC, see http://www.med.umich.edu/urology/research/EPIC/EPIC-2.2002.pdf|18 months|||scores on a scale||Standard Deviation|Mean
177261|NCT00040365|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|3 years|||Participants|||Number
177262|NCT00040365|Secondary|Percentage of Participants With a Good Toxicity Outcome Who Experienced Late Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.|A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. Week 5, 7 were during treatment measuring acute toxicity. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx.|The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment.|||Percentage of Participants|||Number
177263|NCT00040365|Primary|Percentage of Participants With a Good Toxicity Outcome Who Experienced an Acute Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.|A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG (method and scoring of radiation morbidity, etc.) see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx|RTOG Acute was used on week 5 and 7|Number of participants 29 versus 30 = One patient was taken off study due to tumor progression prior to the follow up period.||Percentage of Participants|||Number
177264|NCT00039195|Primary|Progression Free Survival|Kaplan-Meier estimates will be used to verify the progression free survival.|2 years|||percentage of patients progression free||95% Confidence Interval|Number
177268|NCT00039871|Secondary|Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12|Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up|24 weeks posttreatment|Participants with detectable but >=2 log drop in HCV-RNA at Treatment Week 12||Participants|||Number
177269|NCT00039871|Secondary|Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12|Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up|24 weeks posttreatment|Participants who had undetectable HCV-RNA at Treatment Week 12||Participants|||Number
177270|NCT00039871|Primary|Sustained Virologic Response (SVR) Rate|Number of participants with undetectable hepatitis C virus RNA (HCV-RNA)|Assessed at end of 24 weeks posttreatment follow-up|Participants who received at least one dose of study medication||Participants|||Number
177271|NCT00039741|Secondary|Number of Children With HIV-1 RNA Less Than 400 Copies/ml and on Original Randomized Therapy at 24 Weeks||24 weeks|Intent to treat - numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 24.||participants|||Number
177272|NCT00039741|Secondary|Change in CD4% From Randomization to 4 Years||Randomization to 4 years|Intent to treat, for participants who had CD4% values available at 4 years and at baseline.||CD4 percent (% of total lymphocytes)||Standard Deviation|Mean
177273|NCT00039741|Secondary|Number of Children With an HIV-1 RNA Level Less Than 400 Copies/ml Regardless of Therapy at Week 204||Week 204|Intent to treat. Numbers are reported among participants who had an HIV-1 RNA value and were in follow-up at week 204.||participants|||Number
177274|NCT00039741|Secondary|Time to HIV-1 RNA of 30,000 Copies/ml or Greater During Second-line Therapy or Permanent Discontinuation of Second-line Therapy|25th Percentiles in weeks from randomization to HIV-1 RNA of 30,000 copies/ml or greater during second-line therapy or permanent discontinuation of second-line therapy|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat||Weeks (25th Percentile)|||Number
177275|NCT00039741|Secondary|Time to HIV-1 RNA of 400 Copies/ml or Greater During First-line Therapy or Permanent Discontinuation of First-line Therapy|25th Percentiles in weeks from randomization HIV-1 RNA of 400 copies/ml or greater during first-line therapy or permanent discontinuation of first-line therapy.|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat||Weeks (25th Percentile)|||Number
177276|NCT00039741|Secondary|Time to Switching to an Alternative Class ART Regimen (Based on Initial Randomized Regimen)|25th Percentiles in weeks from randomization to starting an alternative class ART regimen (based on initial randomized regimen)|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat||Weeks (25th Percentile)||Inter-Quartile Range|Median
177277|NCT00039741|Secondary|Participants With Significant HIV-related Clinical Events, Defined as CDC Category C (AIDS Defining) Diagnoses (Except for Recurrent Bacterial Infections)or Death||Up to 6 yrs. (average 4.85 yrs.)|Intent to treat||participants|||Number
177278|NCT00039741|Secondary|Rate of Grade 3 or Higher Signs, Symptoms, or Laboratory Abnormalities Experienced|"Adverse events were graded according to the following guidelines:~PACTG: “The Manual for Expedited Reporting of Adverse Events to DAIDS” (DAIDS EAE Manual) dated May 6, 2004.~PENTA: International Conference for Harmonization (ICH) requirements and the EU Clinical Trials Directive 2001/20/EC (20).~A rating of Grade 3 is severe and Grade 4 is life-threatening. The rate of serious (Grade 3 or above)events is reported as the number of events per 100 child/years."|Up to 6 yrs. (average 4.85 yrs.)|Intent to treat||events/100 child-years||95% Confidence Interval|Mean
177279|NCT00039741|Primary|Change in Viral Load Measured in log10 HIV-1 RNA Copies/ml||Baseline visit and 4 years after Study Entry|Intent-to-treat analyses for those subjects who had data at baseline and 4 years. Analyses were done by collapsing groups to examine drug class (regardless of switch point) and switch point (regardless of drug class).||log10 HIV-1 RNA||Standard Error|Mean
177280|NCT00039377|Secondary|5 Year Overall Survival for Autologous & Allogeneic Transplant Groups|Percentage of patients who were alive at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.|5 years from registration|Participants who were on autologous or allogeneic transplant arms were analyzed (N=34).||percentage of patients||95% Confidence Interval|Number
177281|NCT00039377|Secondary|5 Year Disease-free Survival for Autologous & Allogeneic Transplant Groups|Percentage of patients who achieved a complete remission (CR) and were alive and relapse free at 5 years. The 5-year progression free survival was estimated using the Kaplan Meier method.|5 years from CR|Participants who received autologous or allogeneic transplants were analyzed (N=34)||percentage of patients||95% Confidence Interval|Number
177282|NCT00039377|Primary|Disease Free Survival|"Disease-free survival (DFS) was measured as the interval from achievement of complete remission (CR) until relapse or death, regardless of cause; patients alive and in CR were censored at last follow-up. DFS was estimated using the Kaplan Meier method.~A complete remission (CR) was defined as recovery of morphologically normal bone marrow and blood counts (i.e., neutrophils >= 1.5 x 10^9/L and platelets > 100 x 10^9/L) and no circulating leukemic blasts or evidence of extramedullary leukemia and persisting for at least one month."|Duration of treatment (up to 10 years)|One participant was excluded per study design as they did not achieve a complete remission. DFS Analysis was powered to include all patients.||years||95% Confidence Interval|Median
177283|NCT00039377|Secondary|Number of Participants Who Achieved a BCR-ABL Response at 12 Months|"BCR-ABL response is defined in two ways: complete molecular response (CMR) and major molecular response (MMR).~Complete Molecular Response is defined as a Bcr-Abl (a fusion of gene of Bcr and ABl genes) ratio ≤0.0032% on the International Scale Bcr = breakpoint cluster gene Abl = abelson proto-oncogene~MMR is defined as Bcr-Abl (A fusion gene of the breakpoint cluster region [Bcr] gene and Abelson proto-oncogene [Abl] genes) transcript ratio ≤0.1% (≥ 3 log reduction of BCR-ABL transcripts from a standardized baseline), as detected by reverse transcriptase polymerase chain reaction [RT-PCR] (performed centrally)."|12 months|Peripheral blood stem cells were assayed from 13 patients.||participants|||Number
177284|NCT00039377|Secondary|Overall Survival|Overall survival (OS) as the interval from the on-study date until death. OS was estimated using the Kaplan Meier method.|Duration of study (up to 10 years)|OS Analysis was powered to include all participants.||years||95% Confidence Interval|Median
177840|NCT00005906|Primary|Number of Participants With a Reduction in Total Tumor Volume of at Least 20%.|Octreotide treatment will be considered successful if the patient receiving treatment for six months shows a reduction in total tumor mass/ fluid collection or reaccumulation of at least 20%.|Six months|||Participants|||Number
177285|NCT00038948|Secondary|First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.|Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).|52 and 104 weeks|Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min.||patients|||Number
177286|NCT00038948|Primary|Nankivell Glomerular Filtration Rate (GFR)|Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.|52 weeks|Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min.||mL/min||Standard Error|Mean
177287|NCT00038857|Primary|Number of Participants With Absolute Neutrophil Count Engraftment|Absolute neutrophil engraftment defined as first of 3 consecutive days with Absolute neutrophil count (ANC) equal to or more than 0.5 * 10^9/L. Baseline to Day 30 post transplant.|Day 0 up to Day 30|Analysis per protocol.||participant|||Number
177288|NCT00038610|Primary|Disease-Free Survival Rate at 2-year and 5-year.|Disease-Free Survival (DFS) was calculated from the time of complete remission until relapse or death due to any cause.|Baseline to 2-year and 5-year|||percentage of participants|||Number
177289|NCT00038610|Secondary|Overall Survival Rate at 2-year and 5-year.|Overall survival (OS) was calculated from the date of initiation of therapy until death.|Baseline to 2-year and 5-year|||percentage of participants|||Number
177290|NCT00038610|Primary|Response To Induction Therapy With Hyper-CVAD Plus Imatinib Mesylate|"Complete Remission (CR): Defined as the presence of 5% or less blasts in the bone marrow, with a granulocyte count of 1.0 × 109/L or higher and a platelet count of 100 × 109/L and no extramedullary disease.~Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts.~Molecular CR: Same as for CR with RT-PCR negativity for bcr-abl.~Induction Death: Defined as death occurring after start of therapy without meeting the definition of CR or resistant disease."|Baseline to 6 months|Of the 54 participants, 39 (72%) presented with de novo disease, 6 (11%) were refractory to standard induction therapy, and 9 (17%) entered the study in complete remission (CR) after one course of standard induction therapy.||participants|||Number
177291|NCT00038467|Secondary|Number of Participants With Histological Findings: Endometrial Sub-study||Baseline up to 24 months post-treatment|Results were not reported for this outcome measure because no data was collected as per change in planned analysis.|||||
177292|NCT00038467|Secondary|Percentage of Participants With at Least 1 Gynecological Symptoms: Endometrial Sub-study|Gynecological symptoms included bleeding/spotting, pelvic pain, leucorrhoea and vaginal itching.|Baseline up to 24 months post-treatment|As treated population included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.||percentage of participants|||Number
177293|NCT00038467|Secondary|Number of Participants With Polyps, Fibroids and Ovarian Cysts: Endometrial Sub-study|Number of participants with presence of polyps (POL) and fibroids (FIB) at post-baseline time points compared to the baseline (BL) status of ‘yes’, ‘no’ or ‘missing’ (that is, participants reporting POL/FIB at post-baseline time points who had yes, no or missing POL/FIB status at baseline, respectively) were presented. Result for number of participants with ovarian cysts was not analyzed at post-baseline time points as very few participants reported ovarian cysts at baseline.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study. Analysis was based on actual treatment received. 'n' signifies those participants who were evaluable for this measure at given time points for each group,respectively.||participants|||Number
177294|NCT00038467|Secondary|Uterine and Overall Ovary Volume: Endometrial Sub-study|Uterine volume (UV) and ovarian volume was estimated using ultrasonography. Uterine volume = (longitudinal diameter * transverse diameter * anteroposterior diameter of uterus)/(2*1000). Ovary volume = [(longitudinal diameter * transverse diameter * anteroposterior diameter of ovary) * 3.14]/(6*1000). Overall ovary volume (OV) is calculated as the sum of the right and left ovary volume. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.||cubic centimeter (cm^3)||Full Range|Median
177295|NCT00038467|Secondary|Endometrial Thickness: Endometrial Sub-study|Endometrial thickness was assessed using transvaginal ultrasound examination. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.||mm||Full Range|Median
177296|NCT00038467|Secondary|Percentage of Participants With Endometrial Thickness Greater Than or Equal to (>=) 5 Millimeter (mm): Endometrial Sub-study|Endometrial thickness was assessed using transvaginal ultrasound examination. 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|6, 12, 24, 36 months after randomization, 6, 12, 24 months post-treatment|Evaluable population for endometrial sub-study included all treated participants who did not violate any exclusion criteria, received treatment for at least 2 years, and had on-treatment endometrial ultrasound examination performed between 22 and 26 months from treatment start. Analysis was based on actual treatment received.||percentage of participants|||Number
177328|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 72 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 72|Number of subjects enrolled at this time point.||Scores on a scale||Standard Error|Mean
177297|NCT00038467|Secondary|Number of Participants With Severe Endocrine Symptoms: QoL Sub-study|Participants indicated prevalence of an endocrine subscale items using a 5-point scale, where 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). Endocrine items were grouped in five categories vasomotor (hot flushes, cold sweats, night sweats, sleeping difficulties), neuropsychological (lack of energy, nervous feeling, lightheaded/dizzy, headaches, mood swings, feeling irritable), gastrointestinal symptoms (nausea, gained weight, vomiting, diarrhea, bloated feeling), gynecological symptoms (vaginal discharge, vaginal irritation, vaginal bleeding, vaginal dryness, discomfort with intercourse, lost interest in sex, breast tenderness) and other symptoms (pain, feeling ill, side effects). Number of participants who reported severe endocrine symptoms (defined as response categories “quite a bit” and “very much”) were presented.|Baseline up to 24 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||participants|||Number
177298|NCT00038467|Secondary|Change From Baseline in Breast Cancer Subscale (BCS) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The BCS subscale assessed health related QoL in participants with breast cancer. BCS subscale comprised of 9 items (short of breath, self-conscious dress, tender/swollen arms, sexually attractive, bothered by hair loss, worried about familial risk, worried about family stress, bothered by weight change, able to feel like a woman). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total BCS score was calculated as the sum of the 9 items and ranged from 0 to 36, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
177299|NCT00038467|Secondary|Change From Baseline in Functional Well-Being (FWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The FWB subscale assessed functional well-being related QoL in participants with breast cancer. FWB subscale comprised of 7 items (able to work, work fulfilled, able to enjoy life, acceptance of illness, sleeping well, enjoyed normal fun activities, contented with QoL). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total FWB score was calculated as the sum of the 7 items and ranged from 0 to 28, where higher score indicated better functional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
177300|NCT00038467|Secondary|Change From Baseline in Emotional Well-Being (EWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The EWB subscale assessed emotional well-being related QoL in participants with breast cancer. EWB subscale comprised of 6 items (felt sad, proud of coping, lost hope, felt nervous, worried about dying, worried about condition worsening). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equate to a good QoL. Total EWB score was calculated as the sum of the 6 items and ranged from 0 to 24, where higher score indicated better emotional well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
177301|NCT00038467|Secondary|Change From Baseline in Relationship With Doctor (RWD) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Substudy|The RWD subscale assessed relationship with doctor in participants with breast cancer. RWD subscale comprised of 2 items (confidence in doctors, doctor answered questions). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). Total RWD score was calculated as the sum of the 2 items and ranged from 0 to 8, where higher score indicated better relationship with doctor. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
177302|NCT00038467|Secondary|Change From Baseline in Social/Family Well-Being (SWB) Sub-scale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The SWB subscale assessed social/family well-being related QoL in participants with breast cancer. SWB subscale comprised of 7 items (distant from friends, emotional support, support from friends, family acceptance, family communication, close to main support, sexual satisfaction). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total SWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better social/family well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
177859|NCT00004978|Secondary|Number of Participants With Changes in Anti-retroviral Treatment (ART)|Number of participants who changed ART at least once during the study period.|From randomization through study end - median of 7.6 years follow-up|||participants|||Number
177303|NCT00038467|Secondary|Change From Baseline in Physical Well-Being (PWB) Subscale Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The PWB subscale assessed physical well-being related QoL in participants with breast cancer. PWB subscale comprised of 7 items (energy lack, nausea, family needs, pain, side effects, felt ill, forced to stay in bed). Participants indicated how true a statement had been for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total PWB score was calculated as the sum of all the 7 items and ranged from 0 to 28, where higher score indicated better physical well-being related QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
177304|NCT00038467|Secondary|Change From Baseline in Total Functional Assessment of Cancer Therapy – General Breast and Endocrine (FACT-GBE) Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|FACT-GBE assessed health-related quality of life (QoL) in participants with breast cancer. It consisted of 56 items,summarized to 7 subscales(subscale 1 to 6 constituted total FACT-B and subscale 7 constituted total ES):physical well-being(7 items), social/family well-being(7 items),relationship with doctor (2 items),emotional well-being(6 items),functional well-being(7 items),breast cancer subscale(9 items),endocrine symptoms(18 items). Participants indicated how true a statement had been for them using 5-point scale from 0(not at all) to 4(very much). For items that were negatively framed,scores were reversed for analysis so that higher scores equated to good QoL. Total FACT-GBE score=sum of all 56 items(range 0 to 224, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
177305|NCT00038467|Secondary|Change From Baseline in Functional Assessment of Cancer Therapy – Endocrine Subscale (FACT-ES) Total Score at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The FACT-ES assessed health-related QoL in participants with breast cancer. ES subscale comprised of 18 items (hot flushes,cold sweats,night sweats, vaginal discharge,vaginal irritation,vaginal bleeding,vaginal dryness,discomfort with intercourse,lost interest in sex,gained weight,light headed/dizzy,vomiting,had diarrhea,headaches,felt bloated,breast tenderness,mood swings, felt irritable).Participants indicated how true a statement was for them using a 5-point scale from 0 (not at all) to 4 (very much). For items that were negatively framed, the scores were reversed for the analysis so that higher scores equated to a good QoL. Total FACT-ES score was calculated as sum of all the 18 items and ranged from 0 to 72, where higher score indicated better QoL. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.||units on a scale||Standard Deviation|Mean
177306|NCT00038467|Secondary|Change From Baseline in Treatment Outcome Index (TOI) at 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Months: QoL Sub-study|The TOI was defined as the sum of 23 items based on following Functional Assessment of Cancer Therapy – Breast version [FACT-B] subscales: Physical well-being (7 items), Functional well-being (7 items), Breast cancer subscale (9 items). Each item was scaled from 0=‘Not at all’ to 4=‘Very much’. Total TOI score ranged from 0 to 92, where higher TOI score indicated better health-related quality of life (QoL). A change of five points in the TOI scores was considered clinically meaningful. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Results for 30, 36, 48, 60 months were not reported because data for these time points was only summarized as graphical presentation.|Baseline, 3, 6, 9, 12, 18, 24, 30, 36, 48, 60 months after randomization|ITT population for QoL sub-study included all randomized participants with available data for any given endpoint and were grouped according to randomized treatment, irrespective of whether they were actually treated or not.||units on a scale||Standard Deviation|Mean
177307|NCT00038467|Secondary|Number of Participants With Fracture: Bone Metabolism Sub-study||Baseline up to 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received.||participants|||Number
177308|NCT00038467|Secondary|Percentage of N-telopeptide of Type 1 Collagen (NTX) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study|N-telopeptide of Type 1 collagen (NTX) urine concentration (adjusted for urinary creatinine) analyzed using competitive inhibition EIA at post-baseline time points was expressed as percentage of baseline NTX urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
177329|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 48 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 48|||Scores on a scale||Standard Error|Mean
177309|NCT00038467|Secondary|Percentage of Deoxy-pyridinoline (DPD) Urine Concentration Relative to Baseline: Bone Metabolism Sub-study|Deoxy-pyridinoline (DPD) urine concentration (adjusted for urinary creatinine) analyzed using competitive EIA at post-baseline time points was expressed as percentage of baseline DPD urine concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
177310|NCT00038467|Secondary|Percentage of Osteocalcin (OC) and Procollagen T1 C-Peptide (PICP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|Osteocalcin (OC) serum concentration analyzed using ELISA and procollagen T1 c-peptide (PICP) serum concentration analyzed using sandwich EIA at post-baseline time points was expressed as percentage of baseline OC serum concentration and baseline PICP serum concentration, respectively. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points, for each group respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
177311|NCT00038467|Secondary|Percentage of C-Terminal Telopeptide (CTX) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|C-terminal telopeptide (CTX) serum concentration analyzed using competitive enzyme-linked immunosorbent assay (ELISA) at post-baseline time points was expressed as percentage of baseline CTX serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
177312|NCT00038467|Secondary|Percentage of Bone Specific Alkaline Phosphatase (BAP) Serum Concentration Relative to Baseline: Bone Metabolism Sub-study|Bone specific alkaline phosphatase (BAP) serum concentration analyzed using enzyme immuno assay (EIA) at post-baseline time points was expressed as percentage of baseline BAP serum concentration. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 3, 6, 9, 12, 18, 24, 30 months after randomization (on-treatment), 36 months after randomization (end of treatment), 12, 24 months post-treatment|As treated population for bone metabolism sub-study included all treated participants, irrespective of the treatment duration and allocated to the group that corresponded to the treatment they actually received. Analysis population for biomarkers included as treated population with baseline and at least 1 on-treatment assessment available.||percentage of baseline concentration||95% Confidence Interval|Geometric Mean
177313|NCT00038467|Secondary|Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) T-scores at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. Results were scored as T-score. T-score indicated how many standard deviations higher or lower participant’s value was when compared to the young normal reference mean. Using the World Health Organization (WHO) criteria for osteoporosis, a T-score of greater than or equal to (>=)-1.0 was classified as normal, a T-score of greater than -2.5 to less than -1.0 as osteopenic, and a T-score less than or equal to (<=)-2.5 as osteoporotic. Here 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.||T-score||Standard Deviation|Mean
177314|NCT00038467|Secondary|Percent Change From Baseline in Femoral Neck and Femoral Wards Bone Mineral Density (BMD) at 6, 12 and 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for femoral neck (FN) and femoral wards (FW) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.||percent change||Standard Deviation|Mean
177352|NCT00035932|Secondary|HIV IC50 at Week 24|IC50: inhibitory concentration of drug required to reduce viral replication by 50%.|Week 24|Participants with evaluable IC50 measurements; as-randomized population (refers to the treatment regimen assigned at randomization).||ng/mL||Standard Error|Mean
177315|NCT00038467|Secondary|Percent Change From Baseline in Lumbar Spine and Proximal Femur (Total Hip) Bone Mineral Density (BMD) at 6, 12, 24 Months On-treatment and 24 Months Post-treatment: Bone Metabolism Sub-study|BMD measurements for Lumbar spine (LS) and Proximal Femur (Total Hip [TH]) were performed using dual energy X-ray absorptiometry (DXA) for participants who entered the bone-metabolism sub-study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable for this measure at given time points for each group, respectively.|Baseline, 6, 12, 24 months after randomization (on-treatment), 24 months post-treatment|Evaluable population for bone metabolism substudy: all treated participants who did not violate any exclusion criteria, received treatment for at least 9 months and had baseline and at least on-treatment Month 12 and/or Month 24 assessment available for parameter to be analyzed. Participants were analyzed according to treatment actually received.||percent change||Standard Deviation|Mean
177316|NCT00038467|Secondary|Number of Events of Second Breast Cancer in Contralateral Breast: Main Study|Number of events of second primary breast cancer in contralateral breast (excluding ductal carcinoma in situ) were reported.|Baseline up to Month 120|ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.||events|||Number
177317|NCT00038467|Secondary|Overall Survival (OS) at Month 36 Post-Randomization: Main Study|OS was defined as the duration from randomization to death (due to any cause). OS at Month 36 post-randomization was defined as probability of participants’ survival at 36 months after the randomization. For participants who were alive, OS was censored at the last available assessment. Probability of OS at Month 36 post-randomization was reported using Kaplan-Meier estimates at Month 36 post-randomization based on 120-month follow-up data.|Baseline up to Month 120|ITT population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.||probability of OS||95% Confidence Interval|Number
177318|NCT00038467|Primary|Disease-Free Survival (DFS) at Month 36 Post-Randomization: Main Study|DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.|Baseline up to Month 36|Intent-to-treat (ITT) population included all participants assigned to the treatment group to which they were randomized, irrespective of the treatment they actually received.||probability of DFS||95% Confidence Interval|Number
177319|NCT00038103|Secondary|Survival|Time from randomization to date of death (any cause).|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or death|Evaluable population||weeks||95% Confidence Interval|Median
177320|NCT00038103|Secondary|Time to Treatment Failure|Time from randomization to first objective tumor recurrence or progression or death due to any cause or withdrawal from study treatment due to any reason, whichever was the earliest.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population||Weeks||95% Confidence Interval|Median
177321|NCT00038103|Secondary|Time to Tumor Progression|Time from randomization to first objective tumor recurrence or progression or death due to tumor progression in the absence of previous documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLV|Evaluable population||weeks||95% Confidence Interval|Median
177322|NCT00038103|Secondary|Duration of Long-Term SD|Time from start of treatment until the first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression in subjects with long-term SD.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLV|Evaluable population. Number of participants analyzed = number of subjects with long-term SD.||weeks||95% Confidence Interval|Median
177323|NCT00038103|Secondary|Duration of Objective Response (in Subjects With CR or PR)|Time from the first objective documentation of response until the first objective documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population. Number of participants analyzed = number of subjects with objective response.||weeks||95% Confidence Interval|Median
177324|NCT00038103|Secondary|Duration of Clinical Benefit|Time from randomization date to first objective documentation of tumor progression or death due to tumor progression in the absence of previous documentation of tumor progression.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population. Number of participants analyzed = number of subjects with clinical benefit.||weeks||95% Confidence Interval|Median
177325|NCT00038103|Secondary|Number of Subjects With Objective Response|Objective tumor response includes subjects with CR or PR according to RECIST.|Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV|Evaluable population||participants|||Number
177326|NCT00038103|Primary|Number of Subjects With Clinical Benefit|Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.|Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)|Evaluable population||participants|||Number
177327|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 96 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 96|Number of subjects enrolled at this time point.||Scores on scale||Standard Error|Mean
177330|NCT00037830|Secondary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24|||Scores on a scale||Standard Error|Mean
177331|NCT00037830|Secondary|Change in Total UPDRS Score From Baseline to Week 120 Assessed Off Medication|The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Least Squares Mean
177332|NCT00037830|Secondary|Change From Baseline to Week 24 in Total Unified Parkinson's Disease Rating Scale (UPDRS)Score Assessed Off Medication|The total Unified Parkinson's Disease Rating Scale (UPDRS) score is derived from Part I (Mentation, Behavior and Mood), Part II (Activities of Daily Living) and Part III (Motor Examination). Part I assesses 4 functions; Part II assesses 13 activities of daily living; Part III assesses 14 motor symptoms. Each item is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 176. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Least Squares Mean
177333|NCT00037830|Post-Hoc|Estimated Rate of Change in Unified Parkinson's Disease Rating Scale (UPDRS)Motor Scores Assessed Off Medication||Week 36 to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Mean
177334|NCT00037830|Post-Hoc|Estimated Change in Points Per Week on Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score Assessed Off Medication|Unified Parkinson's Disease Rating Scale (UPDRS) A four part scale used to assess the severity of Parkinson's disease symptoms. Part I contains questions concerning the patient's mentation, behavior and mood. Part II asks questions about the patient's ability to perform activities of daily living. Part III is the motor examination of the patient's symptoms ranging in scores from 0 to 4 with 0 equaling either normal or absence of symptoms. The minimum score on this section is 0 and the maximum is 108. Part IV asks the patient questions about any complications of therapy they have experienced within the past week. However, for this study the total UPDRS included Parts I, II, and III. A higher the score on the scale indicates more severe symptoms.|Week 6 to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Mean
177335|NCT00037830|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Scores From Baseline to Week 120 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 120|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Least Squares Mean
177336|NCT00037830|Primary|Change in Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) Motor Score From Baseline to Week 24 Assessed Off Medication.|The Unified Parkinson's Disease Rating Scale (UPDRS) (Part III) motor scores assess 14 symptoms some of which separately assess symptoms in different body parts (e.g. right arm, left arm, right leg, left leg) and each symptom is rated on a scale from 0 (normal) to 4 (severe). The minimum total score possible is 0 and the maximum total score possible is 108. Each subject was independently rated by two observers at each study visit and a mean score was calculated for analysis.|Baseline to Week 24|Analysis was per protocol. Two subjects randomized to the Early-Start group withdrew from the study shortly after starting. The comparison group was not compared statistically to the treatment group since they were not randomized.||Scores on a scale||Standard Error|Least Squares Mean
177337|NCT00036569|Secondary|Number of Participants With a Metabolic and Biological Change in the Brainstem Through Magnetic Resonance Imaging (MRI) Techniques|MRI of the brain will be performed at the NCI prior to cycles 1, 2, 3, 5, 7, and continuing every other month until cycle 27. Following cycle 27 the patient will have an MRI performed every third cycle until cycle 52 at which time they will have an MRI performed annually, and when clinically indicated. Baseline MR images are compared with MR images performed during the various cycles (e.g. cycles 1, 2, 3...) Imaging was exploratory and the degree of change that is considered clinically significant rather than technique related is still being explored.|once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.|||Participants|||Number
177353|NCT00035932|Secondary|Mean ATV, RTV and SQV Minimum Concentration (Cmin) Values|"The minimum or trough concentration (Cmin) of a drug observed after its administration and just prior to the administration of a subsequent dose."|collected at the pre-dose time point after receiving atazanavir for at least four weeks|Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).||ng/mL||Standard Error|Mean
177338|NCT00036569|Secondary|Mean Quality of Life (QOL) Score at Baseline and Follow-Up|QOL questionnaires will be performed prior to every cycle for patients age 6-18 years and their parents until cycle 27 and then prior to every third cycle until cycle 52 when the evaluations will become annual. The QOL (NIH Impact of Pediatric Illness Scale) is too detailed to be described and/or shown here. It is a questionnaire made up of approximately 40 questions-the answers are ranked from 1 to 5 with 5 being no impact and 1 being significant impact-For further details see the protocol.|once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.|||Units on a scale||Standard Error|Mean
177339|NCT00036569|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|8 yrs 11 mo 22 days|||Participants|||Number
177340|NCT00036569|Secondary|Median Time to Progression|Time between the final day of treatment to the day of disease progression.|8 yrs 11 mo 22 days|||Days|||Number
177341|NCT00036569|Primary|Two Year Survival of Pediatric Patients With Diffuse Pontine Gliomas|Survival is measured from the date the patient is registered onto the protocol until the day of death and the date of diagnosis to the date of patient death.|8 yrs 6 mo 0 days|||Percentage of patients|||Number
177342|NCT00036270|Secondary|Number of Participants With New Primary Non-breast Cancers|Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.||Participants|||Number
177343|NCT00036270|Secondary|Number of Events for Time to Relapse|Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.||Events (disease relapse)|||Number
177344|NCT00036270|Secondary|Time to New Primary Breast Cancers|New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).|Baseline (Month 0) up to 5 years|Data was not analyzed due to insufficient number of events reported for the endpoint.|||||
177345|NCT00036270|Secondary|Number of Events for Overall Survival (OS)|Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.|Baseline (Month 0) up to 5 years|ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.||Events (death)|||Number
177346|NCT00036270|Primary|Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years|Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.|Baseline (Month 0) up to 5 years|ITT population included all participants who were randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.||Events (disease relapse or death)|||Number
177347|NCT00036270|Primary|Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years|Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.|Baseline (Month 0) up to 2.75 years|Intent-to-Treat (ITT) population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at 2.75 years.||Events (disease relapse or death)|||Number
177348|NCT00035932|Secondary|HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 48|Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.||log10 c/mL||Standard Error|Mean
177349|NCT00035932|Secondary|HIV RNA Level - Treated Subjects With Evaluable Cmins at Week 24|Week 24 HIV RNA level and change from baseline were summarized for treated subjects with evaluable Cmins.|Baseline, Week 24|Participants with evaluable Cmins; as-randomized population (refers to the treatment regimen assigned at randomization).||log10 c/mL||Standard Error|Mean
177350|NCT00035932|Secondary|Inhibitory Quotient at Week 48|Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.||ratio||Standard Error|Mean
177351|NCT00035932|Secondary|Inhibitory Quotient at Week 24|Inhibitory quotient is a measure of drug exposure and susceptibility in an individual. The IQ is typically calculated as the ratio of Cmin to HIV IC50.|Baseline, Week 24|Participants with evaluable IQ measurements (ie, must have both Cmin and IC50 measurements); as-randomized population (refers to the treatment regimen assigned at randomization).||ratio||Standard Error|Mean
177354|NCT00035932|Secondary|Number of Participants Utilizing Resources for Managing Lipid Elevation|Participants' overall resource utilization for managing lipid elevation that includes the management of side effects of lipid lowering medications, such as those due to drug interactions.|Baseline, Week 24, Week 48|Although the intent of this planned analysis was to provide a model of economic value for Lipid Management, a different approach was taken to create this model which did not require data from this trial, and thus this analysis was not done.||Participants|||Number
177355|NCT00035932|Primary|Mean Change From Baseline in HIV RNA at Week 96||Baseline, Week 96|Randomized participants while on initial regimen||log10 c/mL||Standard Error|Mean
177356|NCT00035932|Secondary|Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) at Baseline, Mid-Study (Week 24), and Final (Week 48)|The EQ-5D has a Visual Analog Scale (VAS), which is a feeling thermometer-like scale with a range between 0 and 100. Patients are required to draw a line from a box on the VAS scale to an actual mark on the thermometer-like scale that corresponds with a number that reflects their self-assessed health status at the time they are completing the questionnaire. Higher VAS scores indicate better overall health. There is no minimum clinically important difference reported in the literature for VAS.|Baseline, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.||units on a scale||Standard Error|Mean
177357|NCT00035932|Secondary|Mean Score of European Quality of Life-5 Dimensions (EQ-5D) Health Index Score at Baseline, Mid-Study (Week 24), and Final (Week 48)|The EQ-5D is a 5-item questionnaire to assess health-related quality of life in 5 health dimensions (mobility, self-care, usual activity, pain/discomfort, anxiety/depression) are scored on a 3-level scale: no problems (1), some problems (2), extreme problems (3). Using a standard algorithm, responses are summarized into a single score, the EQ-5D Health Index Score (HIS), which ranges between 1 (representing perfect health) and 0 (representing the worst imaginable health state or death). The smallest coefficient of change is 0.03.|Baseline, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated with EQ-5D at given time point.||units on a scale||Standard Error|Mean
177358|NCT00035932|Secondary|Adherence to Regimen Though Week 48 Based on MACS the Multicenter AIDS Cohort Study (MACS) Adherence Questionnaire|The MACS adherence questionnaire asks patients how many medication doses they missed during the previous day, 2 days, 3 days and 4 days. Drug-specific questions included adherence with dose and frequency. Adherence was defined as taking all doses and numbers of pills as prescribed for each medication. This strict adherence cut-off was based on the guidelines stating that anything less than excellent adherence may result in a virus breakthrough and development of resistance.|Baseline, Week 24, Week 48|Number of Participants Analyzed=treated participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=subset of treated participants (Given the language limitation, a subset of the AI424045 population was included in the MACS adherence analysis.)||participants|||Number
177359|NCT00035932|Secondary|PR Interval and Change From Baseline by Analysis Time Point|The PR interval is measured from the beginning of the P wave to the beginning of the QRS complex, and reflects the time the electrical impulse takes to travel from the sinus node through the atrioventricular (AV) node and entering the ventricles. The PR interval is therefore a good estimate of AV node function.|Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint||msec||Standard Error|Mean
177360|NCT00035932|Secondary|Fridericia-corrected QT (QTcF) Interval and Change From Baseline by Analysis Time Point|The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval was corrected for heart rate using Fridericia's (QTcF) formula.|Baseline, Week 4 predose, 2-3 hours postdose, 6-12 hours postdose, Week 12, Week 24, Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization). n=number of participants evaluated at timepoint||msec||Standard Error|Mean
177361|NCT00035932|Secondary|Grade 3/4 Laboratory Abnormalities Through Week 48|Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Grades:1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening/disabling, 5=Death. Abnormal values: absolute neutrophil count: ≥500 to <750/mm3 (grade 3), <500/mm3 (grade 4); platelets: 20,000-49,999/mm3 (grade 3), <20,000/mm3 or diffuse petechiae (grade 4); alanine transaminase (ALT): 5.1-10 x upper limit of normal (ULN; grade 3), >10 x ULN (grade 4); aspartate transaminase (AST): 5.1-10 x ULN (grade 3), >10 x ULN (grade 4); bilirubin: 2.6-5 x ULN (grade 3), >5 x ULN (grade 4).|From Enrollment to Week 48|Evaluable treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).||participants|||Number
177362|NCT00035932|Secondary|Fasting Glucose Mean Change From Baseline at Week 48||Week 48|Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).||mg/dL||Standard Error|Mean
177363|NCT00035932|Secondary|Fasting Glucose Mean Change From Baseline at Week 24||Baseline, Week 24|Treated Participants with evaluation at time point; as-randomized population (refers to the treatment regimen assigned at randomization).||mg/dL||Standard Error|Mean
177364|NCT00035932|Secondary|Most Common AEs and AEs of Interest Through Week 48|Prespecified AEs of interest included jaundice, ocular icterus, and hyperbilirubinemia.|From Enrollment to Week 48|Treated participants; as-randomized population (refers to the treatment regimen assigned at randomization).||participants|||Number
177365|NCT00035932|Secondary|Deaths, Serious Adverse Events (SAEs), and Adverse Events (AEs) Through Week 48|AE=any new untoward medical occurrence/worsening of a pre-existing medical condition regardless of causal relationship. SAE=any untoward medical occurrence at any dose that: results in death; is life-threatening; requires/prolongs inpatient hospitalization; results in persistent/significant disability; is cancer; is congenital anomaly/birth defect; results in drug dependency/abuse; is an important medical event.|From Enrollment through Week 48|Randomized participants for Deaths and SAEs; treated participants for all others; as-randomized population (refers to the treatment regimen assigned at randomization). In addition, of the 213 screen failures (not randomized), there were 4 subjects who had an SAE; these are not included in the table below.||participants|||Number
177443|NCT00033293|Secondary|Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing|Descriptive analyses of the scores from additional neurologic assessment tests will be performed.|At diagnosis and yearly for 10 years after diagnosis||||||
177366|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 96, Observed Values|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Week 96|Treated Participants; as-randomized population (refers to the treatment regimen assigned at randomization).||percent change in lipid values|||Number
177367|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 48|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Week 48|Treated Participants, Last Observation Carried Forward (LOCF); as-randomized population (refers to the treatment regimen assigned at randomization).||percent change in lipid values|||Number
177368|NCT00035932|Secondary|Lipid Mean Percent Change From Baseline at Week 24|Mean percent change in total cholesterol, high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, and fasting triglycerides.|Baseline, Week 24|Treated Participants, Last Observation Carried Forward (LOCF), as-randomized population (refers to the treatment regimen assigned at randomization).||percent change|||Number
177369|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 48|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 48 were explored.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.||Pearson Correlation Coefficient|||Number
177370|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin) Inhibitory Quotient (IQ), and Number of PI Mutations at Baseline and CD4 Cell Count Change From Baseline at Week 24|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with CD4 cell count change from baseline at Week 24 were explored.|Baseline, Week 24|Participants with evaluable PK measurements, as-randomized population (refers to the treatment regimen assigned at randomization).||Pearson Correlation Coefficient|||Number
177371|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 48|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 48 were explored.|Baseline, Week 48|Formal population PK/PD analysis was not performed due to difficulties in correlating time of blood sample collection with drug administration, and inability to apply the PK model generated with data obtained from healthy subjects due to newly observed differences in exposure to atazanavir between HIV-infected participants and healthy participants.||Pearson Correlation Coefficient|||Number
177372|NCT00035932|Secondary|Correlation of ATV Minimum Plasma Concentration (Cmin), Inhibitory Quotient (IQ), and Number of Protease Inhibitor (PI) Mutations at Baseline With HIV RNA Change From Baseline at Week 24|Pearson correlations of the Cmin (trough plasma concentration), IQ (the ratio of Cmin of ATV to HIV IC50), and Number of baseline PI Mutations with HIV RNA change from baseline at Week 24 were explored.|Baseline, Week 24|Week 24: Participants with evaluable PK measurements||Pearson Correlation Coefficient|||Number
177373|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 96||Baseline, Week 96|Randomized participants (while on initial regimen) with evaluation at time point||cells/mm3||Standard Error|Mean
177374|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 48||Baseline, Week 48|Randomized participants while on initial regimen (completers censored).||cells/mm3||Standard Error|Mean
177375|NCT00035932|Secondary|Change From Baseline in CD4 Cell Count at Week 24||Baseline, Week 24|Randomized participantsRandomized participants while on initial regimen (completers censored).||cells/mm3||Standard Error|Mean
177376|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 96|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 96|Randomized participants while on initial regimen (completers censored)||participants|||Number
177377|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 48|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 48|Randomized participantsRandomized participants while on initial regimen (completers censored).||participants|||Number
177378|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 50 c/mL) Without Prior Failure at Week 24|Treatment Response = confirmed suppression to LOQ (50 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 24|Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).||participants|||Number
177379|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 96|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 96|Randomized participants while on initial regimen (completers censored).||participants|||Number
177380|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 48|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 48|Randomized participants, as-randomized population (refers to the treatment regimen assigned at randomization).||participants|||Number
177476|NCT00031447|Secondary|Detection of Herpes Simplex Virus (HSV) DNA in the Cerebrospinal Fluid (CSF) by Polymerase Chain Reaction (PCR) at Anytime During the Initial 12 Months of Life.|Number of participants with positive herpes simplex virus (HSV) DNA by polymerase cahin reaction (PCR) in the cerebrospinal fluid of subjects assessed during the initial 12 months of life.|post randomization at 12 months|||Participants|||Number
177381|NCT00035932|Secondary|Participants Achieving Treatment Response (LOQ = 400 c/mL) Without Prior Failure at Week 24|Treatment Response = confirmed suppression to LOQ (400 c/mL). The Algorithm for Treatment Response Without Prior Failure (TRPWF) = participants staying in response at the analysis timepoint without having an intervening, confirmed rebound.|Week 24|Randomized participants while on initial regimen Randomized participants, (completers censored).||participants|||Number
177382|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 96||Week 96|Randomized participants while on initial regimen (completers censored).||Participants|||Number
177383|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48, by PI Sensitivity|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 48|As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity.||participants|||Number
177384|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 48||Week 48|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).||Participants|||Number
177385|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24, by PI Sensitivity|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 50 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 24|As there were multiple efficacy algorithms run and multiple subsets analyzed, it was decided to only use LOQ < 50 on the primary endpoint, and to run LOQ<400 for subsets such as baseline PI sensitivity.||participants|||Number
177386|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 50 c/mL) at Week 24||Week 24|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).||participants|||Number
177387|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 96|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 96.|Baseline, Week 96|Observed case analysis: Randomized participants (while on initial regimen--completers censored) with baseline and on-study measurement.||participants|||Number
177388|NCT00035932|Primary|Mean Change From Baseline in HIV RNA at Week 48||Baseline, Week 48|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).||log10 c/mL||Standard Error|Mean
177389|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (LOQ = 400 c/mL) at Week 48, (Overall and by PI Sensitivity)|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 48, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 48|Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).n=number of evaluable (overall, PI sensitive, PI resistant) participants.||participants|||Number
177390|NCT00035932|Secondary|Participants Achieving Virologic Half Log Suppression (Limit of Quantification [LOQ] = 400 c/mL) at Week 24 (Overall and by Protease Inhibitor [PI] Sensitivity)|Number of participants with a >=0.5 log10 decrease in HIV RNA from baseline or HIV RNA < 400 c/mL at Week 24, by their baseline phenotypic sensitivity to their randomized PI.|Baseline, Week 24|Number of Participants Analyzed=Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization); n=number of evaluable (overall, PI sensitive, PI resistant) participants.||participants|||Number
177391|NCT00035932|Secondary|Mean Change From Baseline in HIV RNA at Week 2||Baseline, Week 2|Treated participants, as-randomized (refers to the treatment regimen assigned at randomization).||log10 c/mL||Standard Error|Mean
177392|NCT00035932|Primary|Mean Change From Baseline in HIV Ribonucleic Acid (RNA) at Week 24||Baseline, Week 24|Randomized participants; as-randomized population (refers to the treatment regimen assigned at randomization).||log10 c/mL||Standard Error|Mean
177393|NCT00035815|Secondary|Rate of Change in ALS Functional Rating Scale.|The final secondary outcome measure was the rate of change in the ALS Functional Rating Scale (ALSFRS-r) score. The ALSFRS-r was completed at each visit (randomization and then at 3, 6, 12, 18 and 24 months post-randomization). This is a scale from 0 to 48 assessing functional impairment in 12 clinically relevant areas in ALS. Forty-eight is normal with full function and zero is total loss of function in all clinical functions. As with the MMT scores a score of 0 was imputed on the day of death. Analysis of the ALSFRS-r scores as a secondary outcome was performed in similar manner as MMT score.|Baseline and 24 months|||Units on a scale per month||Standard Deviation|Mean
177394|NCT00035815|Secondary|Number of Participants Alive and Tracheostomy-free at 24 Months|Patients who elected to proceed to tracheostomy were assessed the month of their procedure. Subjects who continuously utilized non-invasive positive pressure ventilation for greater than 10 days were assessed as being ventilator-dependent on the first day they began continuous Non Invasive Positive Pressure Ventilation (NIPPV). All subjects were followed for the 24 month time period.|baseline to 24 months|||participants|||Number
177395|NCT00035815|Primary|Rate of Change in Composite Manual Muscle Testing (MMT) Score|The primary outcome measure was the rate of change in the MMT score. MMT involved the examination of 34 muscle groups with standard positioning. The final MMT score represented an average of the 34 muscles examined, and ranged from 10 to 0(10 normal strength, 0 paralyzed). The individual muscle score was based on the medical research council (MRC) grading scale (1-5) modified to a 10 point system corresponding to the MRC modifications of plus and minus (5, 5-,4+,4,4-,3+,3, 3-,2,1,0; with 5 being normal strength and 0 paralyzed).|Baseline and 24 months|||MMT units per month||Standard Deviation|Mean
177396|NCT00035555|Other Pre-specified|Number of Participants Meeting Marked Abnormality Criteria for Select Hemolytic, Blood Chemistry, and Urinalysis Laboratory Test Results|Normal laboratory values: Hemoglobin (g/dL): Males (18-64 years) 13.8-17, (65 years and older) 11.8-16.8; Females (18-64 years) 12.0-15.6, F (65 years and older) 11.1-15.5. Platelets (per mm^3) 130,000-400,000. Leukocytes (18 years and older) 3.8-10.8 1000/uL. ALT (u/L)(13 years and older) 0-48.|Days 8 and Months 1, 3, 6, 9, and 12 posttransplant (from Day 1)|All randomized participants who underwent transplantation and who received treatment||Participants|||Number
177504|NCT00028002|Primary|Change in Biological Markers of Imatinib Mesylate, Including C-kit and Tyrosine||to be entered||||||
177397|NCT00035555|Secondary|Number of Participants With Posttransplant Diabetes Mellitus|Posttransplant diabetes mellitus is defined as the need for treatment of hyperglycemia with either an oral agent or insulin for a total of >4 weeks or hemoglobin A1c (HbA1c) >7% in a participant not known to be diabetic prior to transplantation|By Months 1, 3, 6, 9, and 12 posttransplant (Day 1 to Months 1, 3, 6, 9, and 12 )|All randomized participants who received transplants and who were not known to be diabetic prior to transplant||Participants|||Number
177398|NCT00035555|Secondary|Mean LDL Cholesterol, HDL Cholesterol, Total Cholesterol, Triglyceride, and Non-HDL Levels|LDL=low-density lipoprotein; HDL=high-density lipoprotein. Total cholesterol=LDL + HDL + very low-density (VLDL) cholesterol. VLDL=triglycerides divided by 5. Non-HDL cholesterol=Total cholesterol minus HDL cholesterol.|By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)|All randomized participants who received a transplant; n=evaluable participants.||mg/dL||Standard Deviation|Mean
177399|NCT00035555|Other Pre-specified|Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), Treatment-related AEs, and Discontinuations Due to AEs|AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.|Day 1 (posttransplant) continuously to 56 days following last dose of study medication|All randomized participants who underwent transplantation and who received treatment||Participants|||Number
177400|NCT00035555|Secondary|Number of Participants With Hypertension|Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg or, the use of any antihypertensive medication.|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation||Participants|||Number
177401|NCT00035555|Secondary|Percentage of Participants Who Used Antihypertensive Medication|Hypertension is defined as diastolic blood pressure ≥90 mm Hg and/or systolic blood pressure ≥140 mm Hg|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation||Percentage of participants|||Number
177402|NCT00035555|Secondary|Mean Iohexol Clearance|Iohexol, a true glomerular filtration marker, is used to measure glomerular filtration rate.|By Months 1, 6, and 12 posttransplant (Day 1 to Months 1, 6, and 12)|All randomized participants who underwent transplantation||mL/min per 1.73 m^2||Standard Deviation|Mean
177403|NCT00035555|Secondary|Percentage of Participants Who Had Chronic Allograft Nephropathy|Based on postbaseline biopsies|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation and who had at least 1 biopsy following Day 1; n=evaluable participants||Percentage of participants|||Number
177404|NCT00035555|Secondary|Percentage of Participants With Acute Rejection or Presumed Acute Rejection (PAR)|Throughout this study, acute rejection=clinically-suspected and biopsy-proven acute rejection (BPAR). Clinically-suspected rejection is defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function. BPAR includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed. PAR is defined as an elevation in SCr ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function that led the investigator to suspect that the participant had experienced acute rejection, and in whom either the biopsy did not confirm acute rejection and the participant received treatment for acute rejection or the participant received treatment for acute rejection without a biopsy to confirm the diagnosis.|By Months 6 and 12 posttransplant (Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation||Percentage of participants|||Number
177405|NCT00035555|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) or Who Received Treatment for Acute Rejection|BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed. A participant was reported as having had an episode of treated acute rejection if he or she received antirejection therapy during an episode of rejection (clinically-suspected or biopsy-proven rejection).|By Months 3, 6, and 12 posttransplant (Day 1 to Months 3, 6, and 12)|All randomized participants who underwent transplantation||Percentage of participants|||Number
177406|NCT00035555|Secondary|Percentage of Participants With Biopsy-proven Acute Rejection (BPAR) Through Months 6 and 12|BPAR includes all cases in which a biopsy read by the central pathologist demonstrates acute rejection, regardless of the reason that the biopsy was performed.|Through Months 6 and 12 posttransplant (From Day 1 to Months 6 and 12)|All randomized participants who underwent transplantation||Percentage of participants|||Number
177407|NCT00035555|Primary|Number of Participants With an Episode of Clinically-suspected and Biopsy-proven Acute Rejection (CSPAR)|No participant was to receive treatment for acute rejection without a biopsy to confirm the diagnosis. CSPAR=Clinically-suspected rejection, defined as an increase in serum creatinine ≥0.5 mg/dL compared with the baseline value in the absence of other factors known to adversely affect renal function, and biopsy-proven rejection, which includes all cases in which a biopsy was read by the central pathologist as demonstrating acute rejection regardless of the reason why the biopsy was performed.|By Month 6 posttransplant (From Day 1 to Month 6)|All randomized participants who underwent transplantation||Participants|||Number
177408|NCT00033917|Secondary|Language Outcome|"Peabody Picture Vocabulary Test (PPVT) This is a semantic language test. The mean value is 100; standard deviation is 16 points. A higher score means better language; a lower score means poorer language.~There are no subscales to the PPVT. The measurement unit is points on a scale. A score < 70 indicates severely abnormal language function."|at 8 years|Three hundred twenty eight subjects were available at age 8 years. They were tested with the PPVT.||participants with PPVT score < 70|||Number
177409|NCT00033917|Primary|IVH at 5 Postnatal Days|Cranial ultrasounds were performed daily for the first 5 postnatal days; the main outcome measure was intraaventricular hemorrhage (IVH) at 5 days of age|at 5 days|All subjects had negative cranial ultrasounds with no evidence for IVH at 6 - 12 postnatal hours||IVH|||Number
177505|NCT00028002|Primary|Incidence of Adverse Events Grade 3 or Greater Graded According to NCI Common Toxicity Criteria (CTC) Version 2.0 (i.e., Major Toxicity)|The major toxicity rates along with their 95% confidence intervals will be estimated using a binomial distribution.|Up to 5 years||||||
177410|NCT00033657|Secondary|Recurrence-free Survival Time|Recurrence-free survival is measured from the date of complete response to recurrence of the cancer. Patients without recurrence were censored at the last date of known recurrence-free. Median recurrence-free survival time was calculated in the eligible and treated patients.|Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry|||Months||95% Confidence Interval|Median
177411|NCT00033657|Secondary|Overall Survival Time|Survival was measured from the date of randomization onto study to death from any cause.Patients who were still alive at the end of the study were censored at the last date of known alive. Median survival time was calculated in the 81 eligible and treated patients.|Approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry|Eligible, treated patients||Months||95% Confidence Interval|Median
177412|NCT00033657|Primary|Pathologic Complete Response Rate|A patient would have achieved a pathologic complete response if no histopathological evidence of residual tumor is found in the resected esophageal specimen and nodal tissue.|approximately 1 month after completing all treatments, then every 3 months up to 2 years, every 6 months from 2-5 years of study entry and annually 6-10 years from study entry|Eligible, treated patients||percentage of participants||90% Confidence Interval|Number
177413|NCT00033631|Secondary|Normal Tissue Complication Probability||From randomization to last follow-up. Analysis can occur any time after the primary endpoint analysis.||06/2018||||
177414|NCT00033631|Secondary|Tumor Control Probability||From randomization to date of failure (tumor progression) or last follow-up. Analysis can occur any time after the primary endpoint analysis.||06/2018||||
177415|NCT00033631|Secondary|Quality Adjusted Survival by SQLI|This analysis will not be done because there was no difference in survival between the two treatment arms.|From randomization to 5 years.||||||
177416|NCT00033631|Secondary|Global Quality of Life (QOL) by Spitzer QOL Index (SQLI)||From randomization to 5 years.||||||
177417|NCT00033631|Secondary|Erectile Function by International Index of Erectile Function (IIEF)||From randomization to 5 years.||||||
177418|NCT00033631|Secondary|Grade 2 or Greater Genitourinary or Gastrointestinal Toxicity|Rate of acute 2+ grade genitourinary(GU)/gastrointestinal(GI) toxicity graded by Common Toxicity Criteria (CTC) version 2.0|From the start of treatment to 90 days. Analysis occurs at the same time as the primary endpoint|Eligible patients with acute adverse event data who did not withdraw consent.||percentage of participants|||Number
177419|NCT00033631|Secondary|Distant Metastases|Failure time is defined as time from randomization to the date of documented regional nodal recurrence or development of distant disease. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (distant metastasis) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who have not withdrawn consent||percentage of participants||95% Confidence Interval|Number
177420|NCT00033631|Secondary|Local Progression|Failure time is defined as time from randomization to the date of progression (increase in palpable abnormality), failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Failure rates are estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (local progression) or death or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who have not withdrawn consent||percentage of participants||95% Confidence Interval|Number
177421|NCT00033631|Secondary|Disease Specific Survival|Survival time is defined as time from randomization to the date of death due to prostate cancer and is estimated by the cumulative incidence method. Patients last know to be alive are censored at date of last contact. Death due to prostate cancer was defined as primary cause of death certified as due to prostate cancer, or death in association with any of the following conditions: Further clinical tumor progression occurring after initiation of salvage anti-tumor therapy, a rise (that exceeds 1.0 ng/ml) in the serum PSA level on at least two consecutive occasions that occurred during or after salvage androgen suppression therapy, or disease progression in the absence of any anti-tumor therapy.|From randomization to date of failure (death due to prostate cancer) or death from other cause or last follow-up. Analysis occurs at the same time as the primary endpoint.|All eligible patients who did not withdraw consent||percentage of participants||95% Confidence Interval|Number
177422|NCT00033631|Secondary|Prostate-specific Antigen (PSA) Failure by American Society for Therapeutic Radiology and Oncology (ASTRO) Definition|Failure is defined as having 3 consecutive elevations of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before three consecutive elevations were documented. The failure day date was the midpoint between last non-rising PSA and first PSA rise. Failure rates are estimated by the cumulative incidence method. Patients last known to be alive are censored at date of last contact.|From randomization to date of failure (3 consecutive rises) or death or last follow-up. Analysis occurred after patients have been potentially followed for 5 years.|All eligible patients who did not withdraw consent||percentage of participants||95% Confidence Interval|Number
177423|NCT00033631|Primary|Overall Survival|Survival time is defined as time from randomization to the date of death from any cause and is estimated by the Kaplan-Meier Method. Patients last know to be alive are censored at date of last contact.|From randomization to date of failure (death) or last follow-up. Analysis occurs after all patients have been potentially followed for 8 years.|All eligible patients who did not withdraw consent||percentage of participants||95% Confidence Interval|Number
177424|NCT00033540|Secondary|Median Survival Time for Participants With Relevant Biologic Markers|To evaluate in a preliminary fashion relevant prognostic markers in gallbladder and cholangiocarcinoma which may have prognostic implications as predictors of survival. Overall survival measured from time of registration to death, or last contact date.|All patients will be followed until death or three years after registration, whichever is first.|Eligible patients who received genotyping were included in this analysis.||months||95% Confidence Interval|Median
177425|NCT00033540|Secondary|Accrual of Patients With This Disease Site|Only eligible patients who received treatment were evaluable for response and survival outcomes.|1-20 months|Patients with advanced disease accrued between September 2003 to April 2005||participants|||Number
177426|NCT00033540|Secondary|Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. For each patient, worst grade of each event type is reported.|Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment.|Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants|||Number
177427|NCT00033540|Secondary|Overall Survival|Measured from time of registration to death, or last contact date|All patients will be followed until death or three years after registration, whichever is first.|All eligible patients who started treatment were included in assessing response estimates.||months||95% Confidence Interval|Median
177428|NCT00033540|Primary|Response|Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.|Patients assessed at least every six weeks while on protocol treatment|All eligible patients who started treatment were included in assessing response estimates.||participants|||Number
177429|NCT00033514|Primary|Recommended Dose for Phase II||treatment period|patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol.||participants receiving each dose|||Number
177430|NCT00033514|Secondary|Serum Concentration of Herceptin at Specified Time-points.||4 months|||mcg/mL||95% Confidence Interval|Mean
177431|NCT00033514|Secondary|Incidence of Adverse Events||5 years|subjects evaluated for SAEs||participants affected by SAEs|||Number
177432|NCT00033514|Secondary|Duration of Objective Response||5 years|Subjects that achieved objective response (4). All were from phase II.||participants|||Number
177433|NCT00033514|Primary|The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.|"Complete Response:~The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.~Partial Response:~A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission."|5 years|12 patients with measurable disease and no prior trastuzumab in the metastatic setting considered evaluable at the recommended phase II dose level. 2 from phase 1 and 10 from phase 2 Excluded : 14 from Phase I: no measureable disease or previous trastuzumab. Phase II: Withdrawn due to disease complications||participants|||Number
177434|NCT00033371|Secondary|Percent Change in the Area of Plaque-like Duodenal Polyps|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment||||||
177435|NCT00033371|Secondary|Change in Global Colorectal Polyp Burden|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment||||||
177436|NCT00033371|Secondary|Percent Change in Polyp Size in Focal Area(s) of the Colorectum|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Baseline up to 2 months after completion of study treatment||||||
177437|NCT00033371|Secondary|Global Duodenal Polyp Burden|The two-sample t-test or its non-parametric analogue, the Wilcoxon rank sums test will be used.|Up to 2 months after completion of study treatment||||||
177438|NCT00033371|Primary|Percent Change in the Number of Polyps Greater Than or Equal to 2mm in Diameter in Focal Area(s) of the Colorectum|Differences between average treatment effects of two study arms tested using two-sided type I error rate of 5% in two-sample t-test. If model assumptions not met by data or transformations of data, appropriate nonparametric tests (e.g. Wilcoxon rank sums test) were used to compare treatment arms - Percent change of polyp counts from baseline to 6 months, ie [(6 months - baseline) x 100]/baseline (%). For each participant, first were matched polyps between baseline & 6 months by region and landmark and summed over all matched regions on number of polyps >2 mm to calculate total number of polyps >2 mm at baseline & 6 months, respectively. For participants refusing exit colonoscopy, 0% change entered as primary endpoint. Defined ITT All: All patients; if 6-month polyp counts missing = 0% change; ITT Measurable: All participants with baseline & 6 month polyp counts; ITT Evaluable: ITT Measurable participants who also took 80% of treatment, both overall as well as during final 60 days.|Baseline up to 6 months|Analysis was by intent to treat (ITT) with a total of 89 ITT participants measurable by having complete polyp information.||percentage change in polyp count||Standard Error|Mean
177439|NCT00033293|Secondary|Tumor Outcome in Terms of Overall Survival Rate||Assessed up to 10 years||||||
177440|NCT00033293|Secondary|Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death|The EFS and S rates will be calculated.|At 3 years||||||
177441|NCT00033293|Secondary|Long-term Prognosis for Neurologic Recovery by Neurological Examination|A t-test will be performed on the results of each neurologic test, comparing patients who have had disappearance of anti-neural antibodies to patients whose anti-neural antibodies have not disappeared.|At diagnosis and yearly for 10 years after diagnosis||||||
177442|NCT00033293|Secondary|Biology of Neuroblastoma Associated Opsoclonus-myoclonus-ataxia (OMA) Syndrome Specifically by MRI Findings, Anti-neuronal Antibodies, Cerebrospinal Fluid (CSF) Findings and Tumor Biology|Descriptive analyses on biologic variables will be performed|At diagnosis, 6 months, 1 year, 5 and 10 years after diagnosis||||||
177444|NCT00033293|Secondary|Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS)|"The best score at the two time points will be used in this analysis. For a given patient, this best score will be used to calculate the change from baseline. The mean change from baseline for each treatment group will be calculated and compared using a one-sided t-test with a significance level of .05."|Changes from baseline to 6 months or 1 year||||||
177445|NCT00033293|Primary|Number of Responders|A multi-stage design followed by a test of proportions between the treatment arms (chemo vs. chemo + therapeutic immune globulin (IVIG)) will be performed. The first stage of the multi-stage design will also function as an early stopping rule for insufficient activity of chemotherapy in OMA.|Changes from baseline to 2 months, 6 months, and 1 year|Eligible patients||participants|||Number
177446|NCT00032630|Primary|Long-term Composite|Long-term composite endpoint was death from any cause within 1 year, nonfatal myocardial infarction between 30 days and 1 year, or repeat revascularization between 30 days and 1 year.|one-year|||Participants|||Number
177447|NCT00032630|Primary|Short-term End Point|Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later.|30 day|||participants|||Number
177448|NCT00032591|Secondary|Health Care Costs at 2 Year||After 2 years of follow-up for each subject|Randomized participants with at least one day of follow-up, per intent to treat||U.S. Dollars||Standard Deviation|Mean
177449|NCT00032591|Secondary|Cumulative Gain in Health Utilities at 2 Year|Scores range from -0.36 to 1.00 per year, with a negative score indicating a state worse than being dead and a score of 1.00 indicating perfect health. Since the time frame is 2 years, the range is -0.72 to 2.00.|After 2 years of follow-up for each subject|Randomized participants with at least one day of follow-up, per intent to treat||score||Standard Deviation|Mean
177450|NCT00032591|Secondary|DASS at 2 Years of Follow-up|Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS). Scores range from 25 to 225, with lower scores indicating higher satisfaction.|At two years of follow-up|Randomized participants with at least one day of follow-up, per intent to treat||score||Standard Deviation|Mean
177451|NCT00032591|Secondary|Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)|Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio|Full length of follow-up; average of 3 years|Randomized participants with at least one day of follow-up, per intent to treat||percentage||Standard Deviation|Mean
177452|NCT00032591|Primary|Time to First Event (Death, Stroke, Major Bleed)|"Time to first event (death, stroke, major bleed)~The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information."|Time to event|Randomized participants with at least one day of follow-up, per intent to treat||cumulative probability of event||95% Confidence Interval|Number
177453|NCT00032487|Secondary|Secondary Endpoint|New or worsening angina, new transient ischemic attack (TIA), new intermittent claudication or critical limb ischemia with Doppler evidence or total mortality.|Post baseline time to first event up to 82 months|||participants|||Number
177454|NCT00032487|Primary|Primary Major Macrovascular Events|Myocardial infarction (MI), intervention for coronary artery or Peripheral Vascular Disease (PVD), severe inoperable Coronary Artery Disease (CAD), new or worsening Congestive Heart Failure (CHF), stroke, Cardiovascular (CV) death, or amputation for ischemic gangrene.|Post baseline time to the first major macrovascular event up to 82 months|||participants|||Number
177455|NCT00031694|Secondary|Bryostatin 1 Pharmacokinetics||Week 1||||||
177456|NCT00031694|Secondary|Overall Survival|Computed using the Kaplan-Meier estimator.|Up to 8 years||||||
177457|NCT00031694|Secondary|Adverse Events|95% confidence intervals will be computed and presented.|Up to 8 years||||||
177458|NCT00031694|Primary|Response Rate of at Least 30%|Number of participants with a Response rate of at least 30%. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST).|Up to 8 years|||participants|||Number
177459|NCT00031551|Other Pre-specified|Pilot Study: Percentage of Participants Using Word Descriptors of Sensory and Affective Pain Selected by Subjects on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy|Participants selected from 14 word descriptors of sensory (S) pain and 11 word descriptors of affective (A) pain.|day 9 (+/- 24 hours) after conditioning chemotherapy|One subject was in critical condition at day 9 after CT, preventing data collection at this time||percentage of participants|||Number
177460|NCT00031551|Other Pre-specified|Pilot Study: Mean Ratings of Oral Mucositis-related Oropharyngeal Pain Intensity on Day 9 (+/- 24 Hours) After Conditioning Chemotherapy (CT)|Subjects rated pain using the Painometer, a hand-held tool with a visual analogue scale to rate overall pain intensity and a list of 14 sensory and 11 affective pain descriptors ranked by intensity values from 1 - 5. Subjects look at the list of sensory and affective words and select words that describe their pain, including Oral Pain and Oral Pain with Swallowing. . The weighted scores assigned to the words are added to obtain a pain intensity score for the sensory and the affective components. The overall pain intensity is measured on a visual analogue scale which has a range of 1 - 10 with high scores indicating higher pain intensity. The sensory and affective pain scores are otained by adding all of the respective intensity values. The range of possible sensory scores is from 0 - 48 and the range of possible affective scores is from 0 - 37. The sensory and affective scores may be added together to obtain the total pain intensity score, which may range from 0 - 85.|Day 9 (+/- 24 hours) after conditioning chemotherapy|One subject was in critical condition at day 9 after CT, preventing data collection at this time||units on a scale||Standard Deviation|Mean
177461|NCT00031551|Secondary|What is the Toxicity of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment -Related Stomatitis?|Toxicity will be measured by the incidence of adverse events.|2 years|||event|||Number
177462|NCT00031551|Primary|What is the Clinical Efficacy of an Etanercept Mouthwash Used for the Treatment of Autologous or Allogeneic Peripheral Blood Stem Cell Transplant or Bone Marrow Transplant Treatment-related Stomatitis?|Clinical efficacy will be determined by measurement of stomatitis grade and oropharyngeal pain.|2 years|Participants withdrew and analyses were terminated before any data collected.|||||
177463|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Glasgow Coma Scale (GCS).|The assessment scoring for the Glasgow Coma Scale is as follows: 15: no neuropsychological impairment; 12 - 14: mild neuropsychological impairment; 9 - 11: moderate neuropsychological impairment; 6 to 8: severe neuropsychological impairment; and <6: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.||Participants|||Number
177464|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days, and at 6 and 12 Months, as Measured by the Mini-Mental Status Examination (MMSE).|The assessment score for the Mini-Mental Status Examination is as follows: 27 - 30: no neuropsychological impairment; 23 - 26: mild neuropsychological impairment; 16 - 22: moderate neuropsychological impairment; 11 - 15 severe neuropsychological impairment; and <=10: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.||Participants|||Number
177465|NCT00031486|Secondary|Survival With no or Mild Neuropsychological Impairment at 90 Days and at 6 and 12 Months, as Measured by the Mattis Dementia Rating Scale (MDRS)|The assessment scoring for the Mattis Dementia Rating Scale is as follows: 139 - 144: no neuropsychological impairment; 121- 138: mild neuropsychological impairment; 114 - 120: moderate neuropsychological impairment; 87 - 113: severe neuropsychological impairment; and <=86: very severe neuropsychological impairment.|90 days, 6 and 12 months|All subjects that survived and were assessed at 90 days, 6 and 12 months.||Participants|||Number
177466|NCT00031486|Secondary|Median Number of Reported AEs Describing Safety and Tolerance of Valacyclovir (VACV), Evaluated by the Number Adverse Events, Administered at a Dose of 2.0 Grams Given Orally 3 Times a Day for 90 Days.|The measure is the number of adverse events per subject. Adverse events were recorded from time of first dose of study drug through 6 months post start of study drug.|6 months|||Events per participants||Full Range|Median
177467|NCT00031486|Secondary|Effect of Antiviral Therapy on Herpes Simplex Virus (HSV) Deoxyribonucleic Acid (DNA) in Cerebral Spinal Fluid (CSF)|Few CSF specimens were collected on day 90, hence unable to calculate the difference in PCR at day 0 and day 90.[measured quantitatively by polymerase chain reaction (PCR)].|Day 0 and Day 90.|The number of participants analyzed is 0 because there specimens obtained were inadequate and insufficient to analyze.||viral load|||Number
177468|NCT00031486|Secondary|Effect of Study Medication on Quality of Life Measurements.|The SF-36 Questionnaire measures quality of life as reported by the subject. The questionnaire contains 36 questions, each questions can be assigned a maximum score of 100. For each subject, a perfect score would be 3600, hence the higher score is best. The calculated scores reported in the table below reflect the diffence between Day 0 (day study drug started) and Day 90, Day 0 (day study drug started) and Month 6, and Day 0 (day study drug started) and Month 12.|Day 0 and 90, Day 0 and Month 6 and Day 0 and Month 12|All subjects that were assessed at baseline and the following time points: 90 days, 6 and 12 months.||Scores on a scale Change in SF-36||Full Range|Median
177469|NCT00031486|Primary|Survival With no or Mild Neuropsychological Impairment at 12 Months After Initiation of Study Medication as Measured by the Mattis Dementia Rating Scale (MDRS)|Number of subjects who were assessed to have no or mild neuropsychological impairment at 12 months using the Mattis Dementia Rating Scale. (A score of 121 or higher refects no or mild neuropsychological impairment.) Scale is: 139-144 normal; 121-139 mild; 114-120 moderate; 87-113 severe; and <=86 very severe.|One year post therapy.|All subjects that survived to 12 months and were assessed.||Participants|||Number
177470|NCT00031460|Primary|Participants With Neurologic Impairment at 12 Months as Measured by Bayley's Neuro-developmental Assessment.(Mental Scores)|Mental scores of all subjects completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development; and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|||participants|||Number
177471|NCT00031460|Secondary|Detection of Herpes Simplex Virus (HSV) DNA in the Cerebrospinal Fluid (CSF) by PCR at Anytime During the Initial 12 Months of Life.|Number of participants assessed to have a positive herpes simplex virus (HSV) DNA by polymerase chain reaction (PCR) in the cerebrospinal fluid (CSF) at any time during their initial 12 months of life after treatment. The PCR is a technique to help visualize copies of a piece of DNA.|post randomization - 12 months|||participants|||Number
177472|NCT00031460|Secondary|Number of Participants With Two or Fewer Episodes of Cutaneous Recurrence of Herpes Simplex Virus (HSV) Disease Post-randomization During the Initial 12 Months of Life.|Number of participants experiencing 2 or fewer HSV recurrences during the first 12 months of life as measured by assessments and reports at study visits.|post randomization - 12 months|||participants|||Number
177473|NCT00031460|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley’s Neuro-developmental Assessment (Motor Scores).|Motor scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development; and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|||participants|||Number
177474|NCT00031447|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley's Neuro-developmental Assessment.(Mental Scores)|Mental scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: less than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|Two of 4 subjects receiving placebo and completing 6 months of placebo, and 2 of 8 subjects receiving acyclovir and completing 6 months of acyclovir did not complete the 12 month Bayley's Neuro-developmental Assessment(mental); therefore, 2 placebo subject and 6 acyclovir subjects are included in the analysis.||Participants|||Number
177475|NCT00031447|Secondary|Two or Fewer Episodes of Cutaneous Recurrence of HSV Disease Post-randomization During the Initial 12 Months of Life.|Number of participants experiencing 2 or fewer HSV recurrences during the first 12 months of life as measured by assessments and reports at study visits.|post randomization - 12 months|||participants|||Number
177477|NCT00031447|Primary|Participants With Neurologic Impairment at 12 Months as Measured by a Bayley’s Neuro-developmental Assessment.(Motor Scores)|Motor scores of all participants completing 6 months of blinded therapy as measured by the Bayleys neuro-developmental assessment at 12 months. Scores are classified as the following: greater than or equal to 115 suggests accelerated performance; 85 - 114 suggests development within normal limits; 70 - 84 suggests mildly delayed development and less than or equal to 69 suggests significant delayed development.|At 12 months of life.|Three of 4 subjects receiving placebo and completing 6 months of placebo, and 2 of 8 subjects receiving acyclovir and completing 6 months of acyclovir did not complete the 12 month Bayley's Neuro-developmental Assessment (motor score); therefore, 1 placebo subject and 6 acyclovir subjects are included in the analysis.||Participants|||Number
177478|NCT00030992|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|10 years|||Participants|||Number
177479|NCT00030992|Primary|Response Rate|Response rate is the percentage of participants with a response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions, Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions,progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions or the appearance of one or more new lesions, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.|6 weeks|||Percentage of participants|||Number
177480|NCT00030901|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|3 months after randomization and then every 3 months for 3 years|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
177481|NCT00030901|Primary|Presence of Carcinoma of the Prostate as Measured by Biopsy|The primary endpoint is biopsy-proven presence/absence of carcinoma of the prostate within 3 years after randomization to treatment. An end-of-study biopsy at 3 years after randomization will be used to determine presence/absence of prostate carcinoma in those patients not previously diagnosed with prostate carcinoma on study. Biopsies performed within ± 90 days of the 3-year anniversary will be considered end-of-study biopsies. Pathologically confirmed presence of prostate carcinoma may be determined at any time during the 3 years and 90 days after randomization, but absence can only be determined by the end-of-study biopsy.|3 years|All eligible randomized patients who started treatment and have prostate cancer known through an interim biopsy or a biopsy taken at +/- 90 days of the end of study were included in the analysis.||participants|||Number
177482|NCT00030823|Primary|Safety|By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.|2 years|All 13 participants experienced toxicities.||participants|||Number
177483|NCT00030147|Primary|Center for Epidemiologic Studies–Depression Scale (CES-D)|Center for Epidemiologic Studies–Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.|Week 8|The analyses included those subjects who completed eight weeks of study||Units on a scale||Standard Deviation|Mean
177484|NCT00030147|Primary|Center for Epidemiologic Studies–Depression Scale (CES-D)|Center for Epidemiologic Studies–Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week.|Baseline|The analyses included those subjects who started the study.||Units on a scale||Standard Deviation|Mean
177485|NCT00029172|Primary|Twelve Week Depression Outcomes|"Depression remission was defined as HAM-D less than 8 or HAM-D decreased by 50%.~The Hamilton Rating Scale for Depression is measured on a scale from no depression - major depression, 0-52 units on a scale."|Twelve week|||HAM-D depression score||Standard Deviation|Mean
177486|NCT00029146|Other Pre-specified|Any Stroke or Death Within 30 Days After Surgery||within 30 days after surgery|Intention-to-treat. All assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy||participants|||Number
177487|NCT00029146|Secondary|Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization|2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 years of randomization|On-treatment analysis removing four participants assigned to the surgical group who never underwent surgery and censoring on the day of surgery three participants assigned to the nonsurgical group who underwent EC-IC bypass surgery.||percentage of participants||95% Confidence Interval|Number
177488|NCT00029146|Secondary|Summary SS-QOL Score|Summary Stroke Specific Quality of Life score (1-4) askes how self-reported overall quality of life compares with with that before stroke. A higher score indicates is better.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||units on a scale||95% Confidence Interval|Mean
177506|NCT00028002|Primary|Rates of Objective Response (Complete, Partial, and Stable)|The response rates along with their 95% confidence intervals will be estimated using a binomial distribution.|Up to 5 years||||||
177489|NCT00029146|Secondary|Modified Barthel Index 19-20|Modified Barthel Index dichotomized 19-20 vs <= 18. The modifed Barthel Index(0-20) describes the degree of independence in day-to-day self-care activities. A higher score indicates greater independence.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants|||Number
177490|NCT00029146|Secondary|Modified Rankin 0-2|Proportion with Modified Rankin score at 2 yrs, dichotomized 0-2 vs 3-6. The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
177491|NCT00029146|Secondary|Modified Rankin 0-1|Proportion with modified Rankin score, dichotomized 0 or 1 vs 2-6.The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.|at 2 years after randomization or end of trial. Worst case imputed for death and missing values|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
177492|NCT00029146|Post-Hoc|Any Stroke or Death|2 yr Kaplan-Meier estimates of the proportions. Any stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
177493|NCT00029146|Secondary|Death|2 yr Kaplan-Meier estimates of the proportions. Death of any cause|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
177494|NCT00029146|Secondary|Fatal Stroke|2 yr Kaplan-Meier estimates of the proportions. Fatal stroke is a stroke that in the investigator’s opinion led directly to the participants death within 30 days of occurrence|within 2 years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
177495|NCT00029146|Secondary|Disabling Stroke|2 yr Kaplan-Meier estimates of the proportions. Disabling stroke is defined as a modified Barthel Index of <12/20 at the first scheduled return visit more than 3 months after the stroke occurred|within two years after randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
177496|NCT00029146|Secondary|All Stroke|2 yr Kaplan-Meier estimates of the proportions. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours|within 2 yrs of randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
177497|NCT00029146|Primary|Surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization|2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.|within 2 yrs of randomization|Intention to treat principle.All participants analyzed in the group to which they were originally randomized.||percentage of participants||95% Confidence Interval|Number
177498|NCT00029107|Primary|Percent of Patients in Remission|The primary endpoint was the difference in rate of remission between the 2 arms at 6 months from study entry.|month 6|||percent of participants||95% Confidence Interval|Number
177499|NCT00028769|Primary|Overall Survival (OS)|Overall survival is defined from the date of registration to date of death from any cause|0-5 years|All eligible patients who started treatment were included in the analysis||months||95% Confidence Interval|Median
177500|NCT00028769|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|up to 5 years after registration|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included.||Participants|||Number
177501|NCT00028769|Primary|Progression-free Survival|Measured from time of registration to time of first documentation of progression determined from the prostate-specific antigen (PSA) level, clinical criteria, or symptomatic deterioration. PSA progression is defined as a 25% increase greater than baseline. If the patient's PSA level had decrease during the study, a 25% increase from the nadir PSA level, with absolute value of >=5 ng/mL is considered progression. CLinical progress is defined as the appearance of any new lesion at any site or death without documented progression. Symptomatic deterioration is defined as a global deterioration of the health status requiring discontinuation of treatment without objective evidence of progression.|0-5 years (assessed every 3 months if no progression when the chemotherapy had been finished. Once off chemotherapy, assessed every 3 months until progression)|All eligible patients who started treatment were included in the analysis||months||95% Confidence Interval|Median
177502|NCT00028262|Primary|Change in Cellular Granular Osmiophilic Deposits (GRODs) in Electron Micrographs of Peripheral White Blood Cells.|The GRODs in peripheral white blood cells from all patients before and during treatment were analyzed by transmission electron microscopy (TEM) at 30000xmagnification. Two investigators working independently of each other identified and counted the GRODs and the results were averaged.|10 years|Out of 10 enrolled subjects, one subject did not complete study and was lost to follow up.||Average number of GRODs||95% Confidence Interval|Mean
177503|NCT00028093|Primary|Change in Hepatitis C Virus RNA Levels During Phase I||From day 0 to day 3|||log(IU/mL)||Full Range|Median
177507|NCT00028002|Primary|Rate of Disease Progression at 2 Years|Kaplan-Meier estimate of disease progression rate. Disease progression is determined by RECIST criteria (Response Evaluation Criteria in Solid Tumours). (RECIST criteria described here: http://ctep.cancer.gov/protocolDevelopment/docs/recist_guideline.pdf)|From registration to two years|All eligible patients.||percentage of participants||95% Confidence Interval|Number
177508|NCT00027560|Secondary|Extensive Chronic Graft-versus-Host Disease Unrelated and Mismatched Related Patients||up to 2 years post transplant|The number of unrelated and mismatched patients was analyzed as per protocol.||participants|||Number
177509|NCT00027560|Secondary|Extensive Chronic Graft-versus-Host Disease Matched Related Patients||up to 2 years post transplant|The number of matched related patients was analyzed as per protocol.||participants|||Number
177510|NCT00027560|Secondary|Acute Graft-versus-Host Disease Unrelated and Mismatched Related Patients|Grade III-IV Acute Graft-versus-Host Disease|up to 4 months post transplant|The number of unrelated and mismatched patients was analyzed as per protocol.||participants|||Number
177511|NCT00027560|Primary|Acute Graft-versus-Host Disease Matched Related Patients|Grade III-IV Acute Graft-versus-Host Disease|up to 4 months post transplant|The number of matched related patients was analyzed as per protocol.||participants|||Number
177512|NCT00027560|Primary|Overall Survival||24 months post transplant|Population is defined as all participants who received transplant as per protocol.||participants|||Number
177513|NCT00027560|Primary|Overall Survival||12 months post transplant|Population is defined as all participants who received transplant as per protocol.||participants|||Number
177514|NCT00027378|Primary|Depressive Symptoms|Beck Depression Inventory (BDI) Scores measured at Weeks 1-4, 6, 8, 10, 12. The BDI is a subject reported measure that has a minimum score of 0 and a maximum score of 63. A better outcome would consist of values near the minimum end of the scale (0) and a worse outcome would consist of values near the maximum end of the scale (63).|Average score as measured by participant's report on the Beck Depression Inventory (BDI).|||units on a scale||Standard Deviation|Mean
177515|NCT00027378|Primary|Alcohol Use Behaviors|Alcohol use behaviors measured by drinks per week.|Average number of drinks as recorded on the Timeline Follow-Back (subject-reported) measure daily over the 12-week acute phase.|Participants were randomized to either fluoxetine-treated or placebo.||standard drink (14 gr. alcohol)||Standard Deviation|Mean
177516|NCT00027027|Secondary|Pharmacokinetic Measurement of Terminal Half-Life (t1/2 Terminal) in Days|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants||days||Standard Deviation|Mean
177517|NCT00027027|Secondary|Pharmacokinetic Measurement of Initial Distribution Half-Life (t1/2 Initial)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|Only participants in the measured treatment groups where a two-compartment model was used are included in the analysis.||days||Standard Deviation|Mean
177518|NCT00027027|Secondary|Pharmacokinetic Measurement of Steady-State Volume of Distribution (Vss)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|Only participants in the measured treatment groups where a two-compartment model was used are included in the analysis.||mL/kg||Standard Deviation|Mean
177519|NCT00027027|Secondary|Pharmacokinetic Measurement of Volume of Central Compartment (Vc)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants||mL/kg||Standard Deviation|Mean
177520|NCT00027027|Secondary|Pharmacokinetic Measurement of Systemic Clearance (CL)|A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes from infusion start, at 1.5, 4, and 8 hours postdose), 2, 5, 8 and 15 of Cycle 1; Days 1 (predose, 29 minutes from infusion start) and 8 of Cycles 2 and beyond until the follow-up visit (4 weeks after the last infusion)|All enrolled participants||mL/day/kg||Standard Deviation|Mean
177521|NCT00027027|Secondary|Pharmacokinetic Measurement of Area Under the Curve (AUC)|Mean rhuMAb 2C4 serum concentrations versus nominal time profiles for the first two treatment cycles are presented for AUC micrograms per milliliters (ug/mL) by day. A one-compartment model was used for the 0.5 mg/kg dose group, and a two-compartment model was used for the 2–15 mg/kg dose groups.|Days 1 (predose, 89 minutes following start of infusion and at 1.5, 4, and 8 hours postdose) 2, 5, 8 and 15 of Cycle 1; Days 1 (predose and 29 minutes following start of infusion) and 8 of Cycle 2|All enrolled participants||ug*hr/mL||Standard Deviation|Mean
177522|NCT00027027|Primary|Number of Participants With Dose-Limiting Toxicities (DLTs)|"Incidence of DLTs defined as any Grade 3 or 4 major organ toxicity according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2 or any subjectively intolerable toxicity felt by the investigator to be related to rhuMAb 2C4.~One participant in the 15.0 mg/kg dose group experienced a gastrointestinal hemorrhage on Day 16. This event was judged by the investigator to be related to study drug. The participant recovered in 3 days and continued to receive rhuMAb 2C4 beyond Cycle 2.This was the only DLT reported during the first two treatment cycles."|Day 1 of Cycles 1 and 2, and 24 hours after Cycle 2 infusion|All enrolled participants who completed at least 2 cycles of study treatment.||participants|||Number
177545|NCT00025233|Secondary|Performance Status and Age||Baseline||||||
177546|NCT00025233|Secondary|Duration of Progression-free Survival||Period from study entry until disease progression, death or date of last contact, assessed up to 7 years||||||
177547|NCT00025233|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||months||95% Confidence Interval|Median
177523|NCT00027027|Primary|Number of Participants With an Adverse Event (AE), Serious Adverse Event (SAE), or Death|"For this protocol, an AE is defined any untoward medical occurrence (e.g., sign, symptom, disease, syndrome, intercurrent illness, abnormal laboratory finding) that emerges or worsens relative to pretreatment baseline during the treatment or post-treatment periods, regardless of the suspected cause.~For this protocol an SAE was defined as any AE that occurred at any dose if:~It resulted in death (i.e., the AE caused or led to death),~It was life threatening,~It required or prolonged inpatient hospitalization,~It was disabling,~It resulted in a congenital anomaly/birth defect,~It may have jeopardized the participant or may have required medical or surgical intervention to prevent one of the outcomes listed above.~The primary cause of death for all reported cases was disease progression, and all of the deaths occurred following study discontinuation, with one death occurring within 4 weeks of the last treatment day."|Days 1, 2, 5, 8, and 15 of Cycle 1; Days 1, 8, and Week 3, of Cycles 2 and beyond up to 1 year and at the follow-up visit (4 weeks after last infusion)|All enrolled participants||participants|||Number
177524|NCT00026494|Primary|Radiographic Response Assessed by Macdonald Criteria Every 2 Months|All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions.|2 years|||participants|||Number
177525|NCT00026221|Secondary|New Vessel Formation in Patient Tumor Samples|Evaluated using immunohistochemistry.|Up to 2 years|Data were not collected and not assessed.|||||
177526|NCT00026221|Secondary|Comparison of Plasma Levels of VEGF Following Administration of Bevacizumab Alone or in Combination With IFN-alfa|Analyzed by Enzyme-Linked Immunosorbent Assay (ELISA).VEGF only analyzed at baseline.|At baseline|||pg/mL||Full Range|Median
177527|NCT00026221|Primary|Progression-free Survival|Defined as the time from treatment start date until documentation of progressive disease. Evaluated using the new international criteria proposed by the RECIST Committee. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions|Up to 2 years|||months||Full Range|Median
177528|NCT00026221|Other Pre-specified|Toxicity|Evaluated using the National Cancer Institute (NCI) Common Toxicity Criteria version 2.0.|Continuously from the start of treatment to the end of study||||||
177529|NCT00026221|Primary|Objective Response Rate|Measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Evaluated using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.|Up to 2 years|||patients|||Number
177530|NCT00025883|Primary|Triglycerides at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin||Baseline, 6 months, 12 months|||mg/dL||Inter-Quartile Range|Geometric Mean
177531|NCT00025883|Primary|Percentage of Glycosylated Hemoglobin at Baseline, 6 Months, and 12 Months on Treatment With Metreleptin|Percentage of glycosylated hemoglobin at Baseline, 6 months, and 12 months on treatment with metreleptin|Baseline, 6 months, 12 months|||percentage of glycated hemoglobin||Standard Deviation|Mean
177532|NCT00025662|Other Pre-specified|Acute GVHD (Grade 3 or 4) Using the CIBMTR Grading System.||100 days from transplant|All 22 patients who received the selectively depleted transplant||percentage of participants|||Number
177533|NCT00025662|Other Pre-specified|Acute GVHD (Any Grade) Using the CIBMTR Grading System.|Proportion of patients with acute GVHD, grade 1 to 4|100 days from transplant|All 22 subjects who received the selectively depleted transplant||percentage of participants||95% Confidence Interval|Number
177534|NCT00025662|Secondary|Cumulative Non Relapse Mortality|Percent non relapse mortality (actuarial) at analysis in Dec 2011|Dec 2011.|All patients who received the selectively depleted transplant||percentage of participants||95% Confidence Interval|Number
177535|NCT00025662|Secondary|Overall Survival|Percent overall survival (actuarial) at analysis in Dec 2011.|Dec 2011.|all patients who received the selectively depleted transplant including one special exemption||percentage of participants||95% Confidence Interval|Number
177536|NCT00025662|Primary|Treatment-related Mortality|"Nonrelapse mortality in the first 100 days of transplant expressed as a percentage of the total subjects.~This is different from outcome measure 3 (Cumulative Nonrelapse Mortality), which is cumulative non relapse mortality till December 2011."|100 days after stem cell infusion|all 22 patients who received a selectively depleted allogeneic transplant, including one who was a special exemption for not meeting full eligibility criteria||percentage of participants||95% Confidence Interval|Number
177537|NCT00025506|Secondary|Serum and Plasma Concentrations of VEGF and bFGF With PFS||Up to 5 years||||||
177538|NCT00025506|Secondary|Serum and Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF) and bFGF||Up to 5 years||||||
177539|NCT00025506|Secondary|Initial Performance Status and Histological Grade||Up to 5 years||||||
177540|NCT00025506|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||months||95% Confidence Interval|Median
177541|NCT00025506|Secondary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|For those patients whose disease can be evaluated by physical examination, response was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
177542|NCT00025506|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Toxicity Criteria (CTC) v2.0||Up to 5 years||||||
177543|NCT00025506|Secondary|Progression Free Survival||For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle||||||
177544|NCT00025506|Primary|Progression-free Survival (PFS) > 6 Months|Whether or not the patient survived progression-free for at least 6 months.|For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 28-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
177552|NCT00025155|Secondary|Progression Free Survival|"Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first.~Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression."|From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-up|Eligible and treated participants.||Months||95% Confidence Interval|Median
177553|NCT00025155|Primary|Frequency and Severity of Observed Adverse Effects||Every cycle until completion of study treatment up to 30 days after stopping study treatment||||||
177554|NCT00025155|Primary|Tumor Response|"Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval.~Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), >=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation."|Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.|Eligible and treated participants.||percentage of participants||90% Confidence Interval|Number
177555|NCT00024258|Primary|Response Rate After Every 3 Courses During Treatment and Then Every 2-3 Months for 1 Year After Completion of Treatment||1 year|||participants|||Number
177556|NCT00024167|Secondary|Overall Survival From Registration|Overall survival (OS) was computed using the number of months from the date of registration to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.|Followed every 4 weeks from registration until death, up to 7 years.|||months||95% Confidence Interval|Median
177557|NCT00024167|Primary|Overall Survival From Randomization|Overall survival (OS) was computed using the number of months from the date of randomization to the date of death. Participants still alive were censored at the last follow-up date. Kaplan-Meier methodology was used to evaluate OS.|Followed every 4 weeks from randomization until death, up to 7 years.|||months||95% Confidence Interval|Median
177558|NCT00024102|Secondary|Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.|"The National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 was used to evaluate toxicity.~Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death."|Reported during protocol treatment after each cycle|||participants|||Number
177559|NCT00024102|Secondary|Overall Survival Rate at 2.4 Years|Percentage of patients who were alive at 2.4 years. This rate was estimated using the Kaplan Meier method.|Time from registration to death (up to 15 years)|OS used the intent-to-treat approach.||percentage of participants|||Number
177560|NCT00024102|Primary|Relapse-free Survival Rates at 2.4 Years|"Percentage of participants who were alive and relapse-free at time of analysis were counted as Alive without relapse at 2.4 years. Participants who had a first local recurrence, first distant metastasis or death from any cause were counted as relapse, first occurrence. These rates were estimated using the Kaplan Meier method"|randomization until date of first event, or date last known to be event free if no event was reported (up to 5 years)|RFS used the intent-to-treat approach||percentage of participants|||Number
177561|NCT00023764|Primary|Response Rate|The response probability will be estimated. The 95% confidence interval will be provided.|Up to 3 years|||participants|||Number
177562|NCT00023712|Primary|Objective Partial/Complete Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria|Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be >= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD.|From study entry until disease progression/intolerable toxicity/study withdrawal|||participants|||Number
177563|NCT00023712|Secondary|Progression-Free Survival||From study entry up to 5 years|||months||95% Confidence Interval|Median
177564|NCT00023712|Secondary|Overall Survival||From study entry, up to 5 years following disease progression|||months||95% Confidence Interval|Median
177565|NCT00023712|Primary|Frequency and Severity of Observed Adverse Events||Up to 5 years||||||
177566|NCT00023712|Primary|Tumor Response Duration||From study entry, up to 5 years|||months||Full Range|Median
177567|NCT00023673|Secondary|Complete Response Rate at 3 Months After Therapy||From start of treatment until 3 months after completion of therapy||||||
177568|NCT00023673|Secondary|Partial Organ Tolerance Doses for Lung and Esophagus||From start of treatment to end of follow-up||||||
177569|NCT00023673|Secondary|Toxicity||From start of treatment to end of follow-up||||||
177570|NCT00023673|Primary|Percentage of Patients Who Survive at Least 12 Months|Null hypothesis: p<= 62.3% (the best arm of RTOG 94-10); alternative hypothesis: p>= 77.9%. Where p is the percentage of patients alive at at 12 months. Using a one-group chi-square test with alpha = 0.10, a sample size of 50 patients provides at least 87% power to detect a 25% or greater relative increase in the 12-month survival rate, or equivalently, an absolute increase of at least 15.6 percentage points (62.3 versus 77.9). If the point estimate is greater than 71.1% (upper bound), then the conclusion is that the 12-month survival rate from the new treatment significantly improved from 62.3%.|From registration to 1 year|Eligible patients at the MTD dose level who started protocol treatment.||percentage of participants||95% Confidence Interval|Number
177571|NCT00023673|Primary|Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy|"Dose limiting toxicity (DLT) = Grade 3/4 non-hematologic toxicities (excluding nausea, vomiting, and alopecia) and Grade 4 hematologic toxicities. The DLT rate for this study was set at 40% based on RTOG (Radiation Therapy Oncolgy Group) study 94-10. No acute (within 90 days from start of 3DRT) DLT's in the first 5 patients (0/5) or the combination of one acute DLT in the first 5 patients (1/5) and none in the next 2 patients (0/2) was required to deem a given dose level to be acceptable. If at any time a Grade 5 toxicity (death) occurred, accrual would be suspended and the event reviewed by a study chair. At any given dose level, this design gives at least 90% confidence that the true acute DLT rate is less than 40% and the probability of not escalating when the true toxicity rate is 40% or higher is at least 83%.~Rating scale: 0 = not the MTD, 1 = MTD"|From start of treatment to 90 days|The first seven eligible patients who started protocol treatment at each dose level.||units on a scale|||Number
177572|NCT00023452|Secondary|Cumulative Rate of Participants <12 Years Old With Culture-Confirmed or Probable (Clinical) TB Disease Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants <12 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33||12/2015||||
177573|NCT00023452|Secondary|Cumulative Rate of Participants <18 Years Old With Culture-Confirmed or Probable (Clinical) TB Disease Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants <18 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33||12/2015||||
177574|NCT00023452|Secondary|Cumulative Rate of HIV-Infected Participants With Culture-Confirmed or Probable TB Disease at 24 Months After Completion of Study Therapy|Cumulative TB disease rate was defined as number of HIV-infected participants with culture-confirmed TB (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 24 months after completion of study therapy per 100 participants with up to 33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH)||12/2015||||
177575|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed or Probable TB Disease in HIV-Infected Participants Within 33 Months After Enrollment|Cumulative TB disease rate was defined as number of HIV-infected participants ≥2 years old with culture-confirmed TB disease (defined as positive culture for MTB) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th day of the trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline to Month 33||12/2015||||
177576|NCT00023452|Secondary|Percentage of Participants With Resistance to Study Medications in Isolates of MTB From Participants Who Developed Active TB Disease Within 33 Months of Enrollment|Drug-susceptibility testing (DST) was performed on isolates of MTB obtained from participants who developed signs and symptoms of active TB disease (including sputum specimens or specimens from appropriate body site for extrapulmonary TB disease). DST was performed at site's local laboratory and sent to Sponsor for confirmatory susceptibility testing. DST included all drugs currently used to treat TB disease, including pyrazinamide (PZA) and fluoroquinolones. Susceptibility was tested for other drugs at the Sponsor laboratory at the following concentrations: INH, 0.02, 1.0, and 5.0 micrograms per milliliter (µg/mL) and rifampin (RIF), 1.0 µg/mL. Isolates resistant to RIF were assumed to be resistant to RPT.|Baseline up to Month 33|N equals the number of participants who developed active TB disease during the study for which DST was performed.||percentage of participants|||Number
177577|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture Confirmed or Probable (Clinical) TB Disease Among Participants <18 Years of Age Who Completed Study Phase Therapy Within 33 Months of Enrollment|Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 33 months after enrollment (for those who completed therapy within 33 months) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|Per Protocol Population: all enrolled and eligible participants (MITT Population) who completed study drug within targeted time period (11-12 3RPT/INH doses within 10-16 weeks; 240-270 INH doses within 35-52 weeks) or developed TB disease or died while on study therapy (or follow-up) but completed ≥75% of expected number of doses prior to event.||TB cases per 100 participants w/followup|||Number
177578|NCT00023452|Secondary|Percentage of Participants Who Completed the Treatment Regimen|Completion in the 3RPT/INH arm was defined as: received 12 doses of RPT/INH within 16 weeks (12 weeks optimal). However, participants were considered to have completed therapy if at least 11 doses of RPT/INH had been received (~90%) during the 16-week time period. Completion in the 9INH arm was defined as: received 270 doses of INH within 52 weeks (39 weeks optimal). However, participants were considered to have completed therapy if at least 240 doses of INH were received (~90%) during the 52-week period.|Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH)|MITT Population||percentage of participants|||Number
177579|NCT00023452|Secondary|Percentage of Participants With Drug Discontinuation for Any Reason Associated With 3RPT/INH or 9INH|Drug discontinuations for any reason associated with 3RPT/INH or 9INH included all reasons for discontinuation from study treatment, regardless of relationship to treatment.|Baseline up to Month 3 (3RPT/INH) or Month 9 (9INH)|MITT Population||percentage of participants|||Number
177580|NCT00023452|Secondary|Percentage of Participants With Methadone Withdrawal Associated With 3RPT/INH and 9INH Among Participants Receiving Concomitant Methadone|Among participants concomitantly receiving methadone, the development of methadone withdrawal (defined as having >3 new symptoms for >7 days: nausea and vomiting, abdominal cramps, body aches, restlessness, irritability, dilated pupils, tremors, involuntary twitching, lacrimation, rhinorrhea, sneezing, yawning, excessive perspiration, goose flesh, or diarrhea).|Baseline to Month 33||12/2015||||
177581|NCT00023452|Secondary|Percentage of Participants With Death Due to Any Cause||Baseline up to Month 35|Safety Population||percentage of participants|||Number
177582|NCT00023452|Secondary|Percentage of Patients With Grade 3 or 4 Drug Toxicities Associated With 3RPT/INH or 9INH|Drug toxicities (or AEs) were graded using Common Toxicity Criteria (CTC version 2.0, Publish Date April 30, 1999, Cancer Therapy Evaluation Program). Grade 3 and 4 drug toxicities associated with 3RPT/INH or 9INH were defined as treatment-related Grade 3 or 4 AEs (considered either possibly, probably, or definitely related to the study drug by the investigator).|Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH])|Safety Population||percentage of participants|||Number
177583|NCT00023452|Secondary|Percentage of Participants With Drug Discontinuation Due to Adverse Drug Reactions Associated With 3RPT/INH or 9INH|Discontinuation of study drug due to an adverse drug reaction associated with either 3RPT/INH or 9INH was defined as discontinuing treatment and/or study due to a treatment-related adverse event (AE) (considered either possibly, probably, or definitely related to the study drug by the investigator).|Baseline up to 60 days after the last dose of study drug (Month 5 [3RPT/INH] or Month 11 [9INH])|Safety Population: all participants who enrolled in the study and took at least 1 dose of study drug.||percentage of participants|||Number
177584|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed or Probable (Clinical) TB Disease (Regardless of Age) At 33 Months After Enrollment|Cumulative TB disease rate was defined as number of participants (regardless of age) with culture-confirmed TB disease (defined as positive culture for MTB]) or probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB, or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants w/33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to 33 Months|||TB cases per 100 participants w/followup|||Number
177585|NCT00023452|Secondary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants <18 Years of Age at 24 Months Following Completion of Study Therapy|Cumulative TB disease rate was defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for MTB) and those <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, CT scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for AFB], or caseating granulomata at autopsy or biopsy) between enrollment and 24 months after completion of study therapy per 100 participants with up to 33 months of follow-up and was calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 27 (3RPT/INH) or Month 33 (9INH)|MITT Population||TB cases per 100 participants w/followup|||Number
177586|NCT00023452|Primary|Cumulative Rate of Culture-Confirmed TB Disease in Participants ≥18 Years of Age AND Culture-Confirmed or Probable (Clinical) TB Disease in Participants Less Than [<]18 Years of Age at 33 Months After Enrollment|Cumulative TB disease rate defined as number of participants ≥18 years old with culture-confirmed TB disease (defined as positive culture for Mycobacterium tuberculosis [MTB]) and those <18 years old with probable (clinical) TB disease (defined as objective evidence of clinical TB disease [cough, fever, night sweats, weight loss, or hemoptysis] based on history or physical exam plus radiograph, computed tomography [CT] scan, other diagnostic tests PLUS response to antituberculosis therapy AND objective improvement of radiograph or other diagnostic tests; OR evidence of granuloma with organism positive for acid-fast bacilli [AFB], or caseating granulomata at autopsy or biopsy) between enrollment and the 990th Day of the Trial (33 months after enrollment, or end of the trial) per 100 participants with (w/)33 months of follow-up calculated using survival analysis methods (Kaplan-Meier approach).|Baseline up to Month 33|Modified Intention-to-Treat (MITT) Population: all participants who enrolled in study and were eligible (Ineligible=source TB case resistant to INH or rifampin; source TB case culture-negative for MTB; positive TST not confirmed; MTB drug susceptibility test results not available for source TB case; or TB disease at enrollment).||TB cases per 100 participants w/followup|||Number
177587|NCT00023322|Secondary|Histological Response at 5 Years|Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.|5 years|||participants|||Number
177588|NCT00023322|Primary|Histological Response at 3 Years|Histological response is defined as at least 3 point improvement in inflammatory score or 1 point improvement in fibrosis score of the HAI at each liver biopsy.|3 years|Intention to treat||participants|||Number
177589|NCT00023309|Secondary|Histological Response|A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score.|week 196 from randomization|Analysis was intention to treat. Patients with missing values at timeframe of interest was taken as random missing. No imputation was applied.||participants|||Number
177590|NCT00023309|Secondary|Biological Response|A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L).|week 196 from randomization|Intention to treat||participants|||Number
177591|NCT00023309|Secondary|Virological Response|A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL).|Week 196 from randomization|Intention to treat||participants|||Number
177592|NCT00023309|Secondary|HBeAg Loss at Week 196|Loss of hepatitis B surface antigen (HBsAg) at week 196|Week 196 from randomization|Analysis was intention to treat. Patients with missing values at timeframe of interest was taken as random missing. No imputation was applied.||participants|||Number
177593|NCT00023309|Primary|Maintained Combined Response (Virological, Biochemical and Histological Response).|A maintained combined response was defined as a combination of a virological, biochemical and histological responses at weeks 48 and 192. A virological response was defined as a decrease in HBV DNA levels to undetectable by the Amplicor assay (<500 copies/mL). A biochemical response was defined as a decrease in serum ALT levels into the normal range (<41 U/L). A histological response was defined as a decrease in the HAI score by at least three points with no worsening of the Ishak fibrosis score.|196 weeks from randomization|The analysis was intention to treat. Patients with missing values at week 196 were treated as random missing. No imputation was applied.||participants|||Number
177594|NCT00022763|Secondary|Number of Participants With Worst Local Injection Site Reactions|Numbers of Participants With worst local injection site reactions were reported. Localized injection site reactions like erythema, induration, pruritus, nodule and cyst, and ecchymosis were recorded.|Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.||participants|||Number
177595|NCT00022763|Secondary|Number of Participants Who Prematurely Withdrew Due to AE||Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.||participants|||Number
177596|NCT00022763|Secondary|Number of Participants Who Died||Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.||participants|||Number
177597|NCT00022763|Secondary|Number of Participants With Treatment Emergent Grade 3 or Grade 4 Laboratory Abnormalities|Pediatric AIDS Clinical Trials Group (PACTG) toxicity grading scale was used for reviewing and grading clinically significant laboratory abnormalities. PACTG Grade 3 and Grade 4 were considered Severe and life threatening, respectively.|Up to Week 96|Safety Analysis Population: All participants who received at least one dose of study medication were included.||participants|||Number
177598|NCT00022763|Secondary|Number of Participants With Adverse Events (AEs) and Serious AEs|An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.|Up to Week 4 after discontinuation of therapy|Safety Analysis Population: All participants who received at least one dose of study medication were included.||participants|||Number
177599|NCT00022763|Secondary|AUC12h Ratio of Enfuvirtide Metabolite (Ro 50-6343)/ENF (Ro 29-9800)|The ratio of the area under plasma concentration-time curve from time 0 to 12 hours of Enfuvirtide Metabolite (Ro 50-6343) versus enfuvirtide was calculated.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.||Ratio||Standard Deviation|Mean
177600|NCT00022763|Secondary|Minimum Plasma Concentration (Ctrough) for Enfuvirtide and Its Metabolite (Ro 50-6343)|Ctrough is defined as the lowest concentration that a drug reaches before the next dose is administered.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.||mcg/mL||Standard Deviation|Mean
177601|NCT00022763|Secondary|Time to Maximum Plasma Concentration (Tmax) for Enfuvirtide|Tmax is defined as actual sampling time to reach maximum observed analyte concentration.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.||hour||Standard Deviation|Mean
177602|NCT00022763|Secondary|Maximum Plasma Concentration (Cmax) for Enfuvirtide and Its Metabolite (Ro 50-6343)|The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. Cmax was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.||mcg/mL||Standard Deviation|Mean
177603|NCT00022763|Primary|Area Under the Plasma Concentration Time Curve (AUC) From 0-12 Hours for Enfuvirtide and Its Metabolite (Ro 50-6343)|The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was calculated from plasma concentration-time data (on Day 7) using standard non-compartmental pharmacokinetic methods.|Pre-dose (time 0), and 2, 4, 8, and 12 hours post-dose (Week 1)|Intensive PK Analysis Population: The first 12 participants enrolled per age group and all children aged 3 to 6 years who underwent intensive pharmacokinetic sampling at week 1 were included within the intensive PK analysis population.||microgram hour per milliliter (mcg.h/mL)||Standard Deviation|Mean
177860|NCT00004978|Secondary|Plasma HIV RNA Levels|log10 HIV-RNA averaged throughout follow-up|From randomization through study end - median of 7.6 years follow-up|HIV-RNA measurement averaged over followup visits for all participants with at least one follow-up measurement.||log10 HIV-RNA||Standard Deviation|Mean
177604|NCT00022698|Secondary|Number of Participants With Any Adverse Events, Serious Adverse Events and Deaths|An adverse event (AEs) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. A serious adverse event is defined as any event which was fatal (resulted in death), life-threatening (with immediate risk of death), resulted in a new or prolongation of a current hospitalization, resulted in persistent or significant disability or incapacity, was a congenital anomaly or birth defect, considered medically significant by the investigator, required intervention to prevent one or more of the outcomes listed above.|Approximately 43 Months|The Safety Population consisted of all participants who received at least 1 dose of any study drug and had at least one post-baseline safety assessment. This included participants in Cohort 1 and Cohort 2.||Number of participants|||Number
177605|NCT00022698|Secondary|Duration of Overall Complete Response|The duration of overall complete response was assessed from the time that measurement criteria were met for complete response until the first date that recurrent or progressive disease was objectively documented. Participants without observed progressive disease after an objective complete response were censored at the date of the last tumor assessment.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. Data for participants present at the time of assessment was used for analysis.||months|||Number
177606|NCT00022698|Secondary|Duration of Overall Response|Duration of overall response was assessed from the time that measurement criteria were first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease was documented. It was analyzed for responders only. Participants without observed progressive disease after an objective response were censored at the date of the last tumor assessment.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2. Data for participants present at the time of assessment was used for analysis.||months||95% Confidence Interval|Median
177607|NCT00022698|Secondary|Time To Objective Response|The time to objective response is defined as the time from start of treatment to the date of first objective response. Participants who never responded during study were censored at the last tumor assessment or the date of last dose, whichever was later, or at the date of death if occurring prior to response.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||months||95% Confidence Interval|Median
177608|NCT00022698|Secondary|Overall Survival|Overall Survival is defined as the time from start of treatment to the date of death. Participants who did not die were censored at the last date the participant was known to be alive.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||months||95% Confidence Interval|Median
177609|NCT00022698|Secondary|Percentage of Participants With One-year Survival|Survival was measured as the time from start of treatment to the date of death or till one year whichever occurred first.|Up to Month 12|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||percentage of participants||95% Confidence Interval|Number
177610|NCT00022698|Secondary|Time to Treatment Failure|Time to treatment failure was assessed as the time from start of treatment to the time the participant was withdrawn due to any of the reasons such as adverse events, progressive disease, insufficient therapeutic response, death, failure to return, or refused treatment, did not cooperate or withdrew consent.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||months||95% Confidence Interval|Median
177611|NCT00022698|Secondary|Time to Disease Progression|Time to disease progression was assessed as the time from start of treatment to the time the participant was first recorded as having disease progression or died due to causes other than disease progression. If a participant never progressed while being followed, he/she was censored at the date of the last tumor assessment or the date of the last dose if no post-baseline tumor measurement was available.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||months||95% Confidence Interval|Median
177612|NCT00022698|Primary|Tumor Response Rate Based on Tumor Measurement as Per Response Evaluation Criteria In Solid Tumors Version 1.0 (RECIST 1.0)|Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST 1.0). CR is defined as the disappearance of all target and non-target lesions and normalization of tumor marker level. PR is defined as a greater than or equal to (>/=) 30% decrease in the sum of the longest diameter (LD) of the target lesions, taking as reference the baseline sum of LD. Participants who did not have a post-baseline tumor measurement were considered non-responders in the assessment of ORR.|Approximately 43 Months|The All Patients Population included participants who received at least one dose of study drug in Cohort 1 or Cohort 2.||percentage of participants|||Number
177613|NCT00022672|Secondary|Number of Participants With Adverse Events|Number of participants with adverse events as a measure for safety as assessed by the collection of adverse events, laboratory tests for Hematology and Serum Chemistry, clinical assessments and cardiac monitoring.|Throughout the Study (Up to 5 years)|Safety population included all participants who received at least one dose of study drug.||Participants|||Number
177614|NCT00022672|Secondary|Percentage of Participants With Best Tumor Response at End of Study|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.|End of Study (Up to 5 years)|Full Analysis Population includes all randomized participants who received study drug.||Percentage of participants|||Number
177615|NCT00022672|Secondary|Percentage of Participants With Overall Tumor Response at End of Study|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.|End of Study (Up to 5 years)|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.||Percentage of participants|||Number
177616|NCT00022672|Secondary|Time to Response at End of Study|Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.|End of Study (Up to 5 years)|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.||Months||Full Range|Median
177617|NCT00022672|Secondary|Duration of Response at End of Study|Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.|End of Study (Up to 5 years)|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.||Months||Full Range|Median
177618|NCT00022672|Secondary|Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Final Visit Compared to Baseline|"Participants rated their performance status using the ECOG Questionnaire on the following scale: 0=Fully active, perform all pre-disease activities without restriction; 1=Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature; 2=Ambulatory, capable of self-care, unable to carry out any work activities, up and about more than >50% of waking hours; 3=Capable of limited self-care, confined to bed or chair >50% of waking hours; 4=Completely disabled, not capable of any self-care, totally confined to bed or chair; 5=Dead.~The percentage of participants in the following categories:~Improved: Score decrease from baseline. Unchanged: Score the same as baseline. Worse: Score increase from baseline."|Baseline, Final Visit (Up to 24 Months)|Participants from the Full Analysis Population (includes all randomized participants who received study drug) with data available for analyses.||Percentage of participants|||Number
177619|NCT00022672|Secondary|Percentage of Participants With Best Tumor Response at 24 Months|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Best Response was defined as the best response a patient achieves in the study.|24 Months|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.||Percentage of participants|||Number
177620|NCT00022672|Secondary|Percentage of Participants With Overall Tumor Response at 24 Months|Tumor Response levels were determined by the investigator and an Independent Response Evaluation Committee and Reconciled. Overall Response was defined as either complete response or partial response.|24 Months|Participants from the Full Analysis Population (all randomized participants who received study drug) evaluable for response.||Percentage of participants|||Number
177621|NCT00022672|Secondary|Percentage of Participants With Two-Year Survival||24 Months|Full Analysis Population included all randomized participants who received study drug.||Percentage of participants|||Number
177622|NCT00022672|Secondary|Overall Survival at 24 Months|Overall Survival is defined as the number of days from randomization to death.|24 Months|||Months||95% Confidence Interval|Median
177623|NCT00022672|Secondary|Time to Response at 24 Months|Time to response was defined as the number of days from the day of randomization to the day complete response or partial response was first noted.|24 Months|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.||Months||Full Range|Median
177624|NCT00022672|Secondary|Duration of Response at 24 Months|Duration of response was defined as the number of days from the day complete response or partial response was first noted to the day of progression of disease, death or last follow-up.|24 Months|Participants from the Full Analysis population (all randomized participants who received study drug) evaluable for response.||Months||Full Range|Median
177625|NCT00022672|Secondary|Percentage of Participants With Clinical Benefit|Clinical Benefit was defined as stable disease for ≥ six months or complete response or partial response.|24 Months, End of Study (Up to 5 years)|||Percentage of participants|||Number
177626|NCT00022672|Primary|Progression Free Survival (PFS)|PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm^2) an increase of 1.0 cm^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.|24 Months, End of Study (Up to 5 years)|Full analysis population included all randomized participants who received study drug.||Months||95% Confidence Interval|Median
177627|NCT00022659|Secondary|Duration of Progression-free Survival||Up to 5 years||||||
177628|NCT00022659|Secondary|Overall Survival|The observed length of life from entry into the study to death or the date of last contact.|From study entry to death or last contact, up to 5 years.|Eligible and treated patients.||months||95% Confidence Interval|Median
177629|NCT00022659|Primary|Frequency and Severity of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)||Up to 5 years||||||
177630|NCT00022659|Primary|Tumor Response|Complete and Partial Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0|Every other 3-week treatment cycle.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
177631|NCT00022659|Primary|Progression-free Survival at 6 Months|Whether or not the patient survived progression-free for at least 6 months.|Every other 3-week treatment cycle.|Eligible and treated patients.||percentage of participants||90% Confidence Interval|Number
177639|NCT00022633|Secondary|Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)|Complete response (CR) is defined as complete disappearance of all measurable and non-measurable disease. No new lesions. No disease related symptoms. Partial response (PR) applies only to patients with least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.|every week for the first 4 weeks and then every 3 weeks for up to 19 weeks|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||percentage of participants||95% Confidence Interval|Number
177907|NCT00004092|Primary|Five-Year Relapse-free Survival|RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.|Five years|||percentage of participants||95% Confidence Interval|Number
177632|NCT00022633|Secondary|Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||percentage of participants|||Number
177633|NCT00022633|Secondary|Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for the each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. One non-compliant patient who did not complete any of the forms was excluded. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||minutes||Full Range|Median
177634|NCT00022633|Secondary|Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate|Patients were required to complete three self-administered questionnaires at entry, prior to the administration of any cytotoxic therapy: the Medical Conditions Questionnaire, Instrumental Activities of Daily Living Form that evaluates functional status, and the Feelings Questionnaire that evaluates depression status. Feasibility is defined in four ways: 1) submission rates for each of three patient self-administered questionnaires (> 60%); 2) the number of items missing within each scale (< 5%); 3) a description of the level of assistance required for self-administration of the questionnaires; and 4) the average amount of time it takes patients to complete each of the three questionnaires. Level of assistance is defined as the need to 1) read the questionnaire to the patient, 2) explain the meaning of items, 3) explain the response format, and 4) complete the questionnaire for the patient; an other category of assistance will be included.|at study entry (prior to administration of any treatment)|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||percentage of participants|||Number
177635|NCT00022633|Primary|Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols|Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.|66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)|A total of 55 patients aged 70 years and older were registered to this protocol from July, 2001 to December, 2006.||participants|||Number
177636|NCT00022633|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.|Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.|Eligible patients aged 70 years and older who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3, Grade 4, or Grade 5 which deemed to be related to protocol treatment are included. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study are excluded||Participants|||Number
177637|NCT00022633|Secondary|Overall Survival (OS) in Patients Aged 70 Years and Older|Measured from date of registration to date of death due to any cause.|0-5 years|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||months||95% Confidence Interval|Median
177638|NCT00022633|Secondary|Progression-free Survival in Patients Aged 70 Years and Older|Measured form date of registration to date of first observation of progression disease, death due to any cause, symptomatic deterioration, or early discontinuation of treatment.|0-5 years|Eligible patients aged 70 years and older who had received any treatment were included in the analysis. Patients aged 60 years or younger who served as a younger reference group for the pharmacokinetic study were excluded from analysis.||months||95% Confidence Interval|Median
177640|NCT00022516|Secondary|Breast Cancer-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention-to-treat (N=1081 patients)||percentage of participants||95% Confidence Interval|Number
177641|NCT00022516|Secondary|Distant Recurrence-free Interval|Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention-to-treat (N=1081 patients)||percentage of participants||95% Confidence Interval|Number
177642|NCT00022516|Secondary|Overall Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.|5-year estimates, reported at a median follow-up of 6.9 years|Intention to treat (N=1081 patients)||percentage of participants||95% Confidence Interval|Number
177643|NCT00022516|Primary|Disease-free Survival|Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.|5-year estimates, reported at a median follow-up of 6.9 years|Intention to treat (N=1081 patients)||percentage of participants||95% Confidence Interval|Number
177644|NCT00022490|Secondary|The Rate of Complete Hematologic Responses at 6 and 12 Months||6 and 12 months||||||
177645|NCT00022490|Secondary|The Rate of Minor Cytogenetic Responses at 6 and 12 Months||6 and 12 months||||||
177646|NCT00022490|Secondary|The Rate of Complete and Major Cytogenetic Responses at 12 Months||12 months||||||
177647|NCT00022490|Secondary|The Rate of Complete Cytogenetic Response at 6 Months||6 months||||||
177648|NCT00022490|Primary|The Rate of Major Cytogenetic Response at 6 Months|Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.|6 months|||Participants|||Number
177649|NCT00021541|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|8 years|Adverse event data is in compliance with DSMB (Data Safety Monitoring Board).||Participants|||Number
177650|NCT00021541|Primary|Median Time to Progression|Median time to progression is defined as a greater than or equal to 20% increase increase in the sum of the volume of all index lesions based on volumetric analysis utilizing magnetic resonance imaging (MRI).Start of phase A or phase B to time of progression.|8 years|phase A - 62 started and 2 were ineligible = 60 phase B - 43 started||Months||95% Confidence Interval|Median
177651|NCT00021255|Secondary|Overall Survival- Percentage of Participants Who Survived at 10 Years|Overall survival of the participants was measured from the date of randomization up to the date of death due to any cause. Overall survival was estimated using the Kaplan-Meier method.|From randomization until death or up to 10 years|ITT population.||percentage of particpants||95% Confidence Interval|Number
177652|NCT00021255|Secondary|Percentage of Participants With Disease Free Survival at 10 Years|Disease free survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.|From randomization until relapse or death or up to 10 years|ITT population.||percentage of participants||95% Confidence Interval|Number
177653|NCT00021255|Primary|Percentage of Participants With Disease Free Survival at 5 Years|Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.|From randomization until relapse or death or up to 5 years|ITT population.||percentage of participants||95% Confidence Interval|Number
177654|NCT00021229|Secondary|Pre-treatment Vascular Endothelial Growth Factor Values From Plasma|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Vascular endothelial growth factor (VEGF) may play a role in tumor development by helping tumor vessels establish and grow. Blood (plasma) was drawn from participants before treatment to measure the baseline plasma VEGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment blood samples for the biomarker study.||pg/ml||Standard Error|Mean
177655|NCT00021229|Secondary|Pre-treatment Vascular Endothelial Growth Factor From Urine|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Vascular endothelial growth factor (VEGF) may play a role in tumor development by helping tumor vessels establish and grow. Urine was collected from participants before treatment to measure the baseline urine VEGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment urine samples for the biomarker study.||pg/ml||Standard Deviation|Mean
177656|NCT00021229|Secondary|Pre-treatment Basic Fibroblast Growth Factor Values From Plasma|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Basic fibroblast growth factor (bFGF) may play a role in tumor development by helping tumor vessels establish and grow. Blood (plasma) was drawn from participants before treatment to measure the baseline plasma bFGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment blood samples for the biomarker study.||pg/ml||Standard Deviation|Mean
177657|NCT00021229|Secondary|Pre-treatment Basic Fibroblast Growth Factor Values From Urine|This study attempted to investigate in an exploratory manner the effect of biological markers on tumor growth. Basic fibroblast growth factor (bFGF) may play a role in tumor development by helping tumor vessels establish and grow. Urine was collected from participants before treatment to measure the baseline urine bFGF values.|Pre-treatment|Per protocol, the analysis population consists of participants treated on the phase I component who submitted pre-treatment urine samples for the biomarker study.||pg/ml||Standard Deviation|Mean
177861|NCT00004978|Secondary|Absolute CD4 Cell Counts Averaged Throughout Followup|Average of all available CD4+ cell counts measured at follow-up visits|from randomization through study end - median of 7.6 years follow-up|CD4+ cell counts averaged over all participants with at least one CD4+ measurement recorded during follow-up.||cells/mm^3||Standard Deviation|Mean
177658|NCT00021229|Secondary|Median Overall Survival|Overall Survival (OS) is defined as the interval from initiation of treatment to death or date of last contact for surviving patients.|Assessed before radiation therapy, before the first dose of imatinib, then every 8 weeks.|The analysis population consists of the stratum I participants who received imatinib mesylate at or above the maximum tolerated dose. The median survival reported is based on these 20 participants.||Days||95% Confidence Interval|Median
177659|NCT00021229|Secondary|Peak Concentration (Cmax)|Peak concentration (cmax) is a pharmacokinetic measure defined as the highest concentration of a drug measured after the drug is administered. The cmax of imatinib mesylate on day 1 of course 1 is reported. Two milliliter (0.5 ml for children under the age of 5) blood samples were collected immediately prior to imatinib mesylate administration on Day 1 of Course 1 and at the following timepoints following drug administration: 0.5, 1, 1.5, 2, 4, 10 and 12 hours after the morning dose.|Day 1 of Course 1|The analysis population consists of participants who enrolled at the maximum tolerated dose (MTD) of the phase I component and who submitted day 1 course 1 samples for the PK studies. An MTD was not estimated in stratum IIB. For this stratum, reported are values at the stratum IIA MTD to allow comparison.||µg/ml||Full Range|Mean
177660|NCT00021229|Secondary|Change From Baseline in Volume FLAIR at Two Weeks After Completion of Radiation|This study attempted to investigate in an exploratory manner the effect of radiation (RT) on changes in various neuroimaging variables in pediatric brainstem gliomas (stratum I). Neuroimaging changes may have some association with outcome (response, survival, etc.). Volume FLAIR is one parameter obtained from standard magnetic resonance imaging (MRI) studies of the brain. Volume FLAIR was obtained at baseline (pre-radiation) and within two (+/- one) weeks after completion of RT.|Baseline and two weeks post completion of radiation|The analysis population consists of Stratum I patients enrolled who had both pre and post radiation (RT) volume FLAIR measures. Stratum II participants did not receive RT and thus were not included.||cubic centimeters||Full Range|Mean
177661|NCT00021229|Primary|Median Progression-free Survival (PFS)|Progression-free survival is defined as the interval from initiation of treatment to the earliest of disease progression (tumor increase of 25% over baseline tumor measurement; appearance of new lesion(s); or progressive/worsening neurological status) or death for patients who failed, or to the last date of follow up for patients without failure.|Assessed pre-radiation, before the first dose of imatinib, and then every 8 weeks|Per protocol, 40 participants who received at least one dose of drug were needed for this objective. The analysis population consists of stratum I participants enrolled at the maximum tolerated dose (phase 1) and the participants enrolled to the phase II part. The study was terminated because of poor accrual and the objective was not met.|||||
177662|NCT00021229|Primary|Number of Participants in Phase I Stratum II With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy|The dose limiting toxicity (DLT) analysis population consisted of phase I stratum II participants who developed DLT during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD. The estimated MTD based on the DLT analysis population of 20 in stratum IIA was 465 mg/m2/day. An MTD was not established in stratum IIB as no DLTs were observed at the higher dose levels of 620 and 800 mg/m2/day.|Day 1 of Imatinib Mesylate Therapy to Week 8|Per protocol, participants included phase I stratum II participants who developed dose-limiting toxicities (DLT) during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs.||Participants|||Number
177663|NCT00021229|Primary|Number of Participants in Phase I Stratum I With Dose Limiting Toxicities (DLT) Observed During First 8 Weeks (Courses 1 and 2) of Imatinib Therapy|The dose limiting toxicity (DLT) analysis population consists of phase I stratum I participants who developed DLT during the maximum tolerated dose (MTD) estimation period (course 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without DLTs. DLTs observed during courses 1 and 2 were used to estimate the MTD. The estimated MTD based on the 23 participants who either had a DLT during course 1 or 2 or completed courses 1 and 2 without DLT is 265 mg/m2/day.|Day 1 of Imatinib Mesylate Therapy to Week 8|Per protocol, participants included phase I stratum I participants who developed dose-limiting toxicities during the maximum tolerated dose (MTD) estimation period (courses 1 and 2) or who completed the MTD estimation period (courses 1 and 2) without dose-limiting toxicities.||Participants|||Number
177664|NCT00020722|Secondary|Overall Survival||Length of time from day of transplant until death.|Trial converted to a proof-of-principle or concept trial; 7 eligible pts received their ATC infusions, 5 were evaluable. This small number of pts is not adequate for progression-free survival or overall survival analysis, collected and analyzed the data for cytotoxicity, IFN-g EliSpots and serum antibodies to monitor for immune responses.|||||
177665|NCT00020722|Primary|Disease-free Survival||Length of time from day of transplant until recurrence or relapse.|Trial converted to a proof-of-principle or concept trial; 7 eligible pts received their ATC infusions, 5 were evaluable. This small number of pts is not adequate for progression-free survival or overall survival analysis, collected and analyzed the data for cytotoxicity, IFN-g EliSpots and serum antibodies to monitor for immune responses.|||||
177666|NCT00019747|Primary|Time to Progression|Time to progression was measured from the on study date until the date of progression or last follow up. Progression was assessed by the Response Evaluation Criteria for Solid Tumors (RECIST).Progressive Disease (PD)is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions|62 months|The analysis was not done because there were not enough subjects to do any of the statistical analyses.|||||
177667|NCT00019604|Secondary|Evaluate the Ability of Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) to Monitor Response Following Radiofrequency Ablation (RFA)|PET scan images was to be read by a physician experienced in the interpretation of whole body PET imaging. The region of interest was to be performed in any abnormal sites of uptake that is a candidate and or has been RFA ablated.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
177713|NCT00012298|Secondary|Appearance of Tumor and Normal Organ Images on the Second In2B8 Scan (Phase I)|Calculated from the serial gamma camera images. Compared using a signed-rank-test. Scatter plots will be used to further explore relationships between these residence times and Bland- Altman methods can be used to assess the agreement between the first and second In2B8 scan residence times.|At week 12||||||
177668|NCT00019604|Secondary|Compare the Performance of Fludeoxyglucose (18F) Positron-Emission Tomography to Computed Tomography and Magnetic Resonance Imaging With Respect to Their Ability to Assess the Effects of Radiofrequency Ablation on the Treatment of Hepatic Neoplasms|Images obtained by the FDG-PET, MRI and CT was to be processed for changes in measured parameters and quantified compared to baseline (e.g., <median change, >median change in size on CT, computed by subtracting the baseline value from the value at the appropriate follow-up point).|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
177669|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Serum Markers|Images obtained by the FDG-PET was to be processed for changes in measured parameters and quantified compared to serum markers at baseline and appropriate follow-up points.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
177670|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Biopsies|Participants were to undergo tissue biopsies of tumor to quantify changes in the tumor to see if the changes we see on the imaging studies are the same as the changes in the tumor.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
177671|NCT00019604|Secondary|Compare Fludeoxyglucose (18F) Positron-Emission Tomography (FDG-PET) Results With Computed Tomography (CT)|Participants were to undergo FDG-PET scanning and CT scans to compare changes in size of metabolically active volume and standard uptake value (tumor metabolism).|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
177672|NCT00019604|Secondary|Percentage of Participants With a Response Using Fludeoxyglucose (18F) - Positron Emission Tomography (FDG-PET) Following Radiofrequency Ablation (RFA)|Response was to be evaluated by the standard response criteria. Complete response is the complete disappearance of the index lesion on follow-up scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.|Baseline, 6 weeks, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
177673|NCT00019604|Secondary|Tumor Vascular Density|Tumor vascular density was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density. Patterns of MRI contrast uptake within tumors correlate with microvessel density.|Baseline, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
177674|NCT00019604|Secondary|Tumor Blood Flow|Tumor blood flow was to be assessed by magnetic resonance imaging (MRI) and compared to data collected on baseline pretreatment images and other appropriate time points for changes in tumor microvascular density.|Baseline, 3 months, and 6 months following treatment|This outcome measure was not analyzed because the investigator left the institution and the study never completed; all participants were taken off study.|||||
177675|NCT00019604|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|9 years, 9 months|NA is entered for the total number of participants with adverse events because it is unknown. Adverse event data is available but the format is uninterpretable.||Participants|||Number
177676|NCT00019604|Primary|Response|Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared to the pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.||The time frame for this outcome measure is unknown; the investigator left the institution and there is no available data. We only have access available on 23 participants. We cannot comment on the others or verify because we do not have the data.||Participants|||Number
177677|NCT00016913|Secondary|Progression-free Survival (PFS)|PFS was defined as the time between treatment initiation and the date of disease progression (PSA, bone, tumor) or death, whichever occurred first. PSA progression is defined as 2 consecutive rising PSAs (a rise of at least 0.2 ng/mL) above 1.0 ng/mL.|registration to progression, up to 5.5 years from registration|All 27 evaluable patients were used in this analysis||months||95% Confidence Interval|Median
177678|NCT00016913|Secondary|Time to Prostate-specific Antigen Failure|PSA progression was defined in 2 ways. The CALGB PSA progression was defined as 2 consecutive rises in PSA with a rise of at least 0.2 ng/mL and above 1.0 ng/mL after radiation therapy; the date of PSA failure is taken as the midpoint between the last PSA before the rise and the first of the 2 PSAs that documented the rise. In addition, PSA progression was used according to the American Society for Therapeutic Radiology and Oncology 1996 (ASTRO) criteria and defined as 3 consecutive rises in PSA after radiation therapy. The date of PSA failure was taken as the midpoint between the time of the lowest PSA measure after irradiation and the first of the 3 consecutive rises.|PSA was measured every 4 weeks during chemotherapy, at least every 12 weeks post radiation for 2 years, and every 6 months thereafter until PSA failure date (Up to 5.5 years).|All 27 evaluable patients were used in this analysis.||months||95% Confidence Interval|Median
177679|NCT00016913|Primary|Toxicity|Patients were evaluated for acute toxicities defined as grade 3 or greater cardiovascular (including venous thrombosis), gastrointestinal, or genitourinary toxicity occurring during the period starting from treatment initiation until 90 days or less after the completion of radiotherapy. The same toxicity measures were monitored at >90 days after the completion of radiotherapy.|90 days and 1 year post treatment|Final analyses were performed on all 27 eligible patients.||Events|||Number
177680|NCT00018031|Primary|Participants With Viral Decline at Day 3 & 28 With Predictors of Post Treatment Response|"HCV viral kinetics were used to predict rates of sustained virology response (SVR) in HIV/HCV connected subjects.~Measure was determined by analyzing the population of participants with virologic decline of more than 1.0 log at day 3 combined with viral load of less than 5.0 log IU/ml at day 28 to predict sustained virology response"|Day 3 and Day 28|Participants with Virologic decline at both Day 3 and absolute HCV VL at Week 28 were analyzed||participants with post treatment svr|||Number
177681|NCT00017563|Primary|Number of Participants With 5-year Freedom From Prostate Specific Antigen (PSA) Recurrence.|Number of participants that experienced 5-year freedom from Prostate Specific Antigen (PSA) recurrence (PSA > 0.4 ng/ml confirmed by a second PSA that is higher than the first by any amount (2)) in men with high risk localized prostate cancer treated with neoadjuvant docetaxel/mitoxantrone followed by surgery.|Every 3 months after surgery for up to 5 years.|||participants|||Number
177682|NCT00016354|Secondary|Test for Antitumor Activity in Blood and Tissue||baseline||||||
177683|NCT00016354|Secondary|Area Under the Plasma Concentration Versus Time Curve (AUC) of BPU||8 weeks||||||
177684|NCT00016354|Secondary|Number of Patients With Adverse Events||every 4 weeks||||||
177685|NCT00016354|Primary|Determine Maximum Tolerated Dose of BPU|Toxicity was assessed weekly during the first 2 cycles, and monthly thereafter, using the National Cancer Institute Common Toxicity Criteria (NCI CTCv2). Dose limiting toxicity (DLT) was defined as dose delays >2 weeks, grade 4 haematologic toxicity (except grade 4 neutropenia lasting <5 days), or grade 3 nonhaematologic toxicity. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience a dose-limiting toxicity.|4 weeks (1 course of treatment for each subject)|Participants that completed at least 1 cycle of BPU.||milligrams (mg)|||Number
177686|NCT00015847|Primary|Major Cytogenetic Response After 6 and 12 Months of Treatment.|"Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows:~Complete* (0% Ph-positive cells) Partial* (1-34%) Minor (35-95%) None (96-100%).~*Major cytogenetic response includes complete and partial cytogenetic response."|6 and 12 months after treatment|||Participants|||Number
177687|NCT00015847|Primary|Treatment-related Toxicity (i.e., Grade 3 or 4 Nonhematologic Toxicity) as Measured by NCI CTCAE v3.0 (Phase I)|1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death|12 Months|||Participants|||Number
177688|NCT00015847|Primary|Molecular Response in Patients With Complete Cytogenetic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II||||||
177689|NCT00015847|Primary|Complete Hematologic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II||||||
177690|NCT00015847|Primary|Minor Cytogenetic Response at 6 and 12 Months (Phase II)||At 6 and 12 months during phase II||||||
177691|NCT00015847|Primary|Complete Cytogenetic Response at 6 and 12 Months (Phase II)|"Cytogenetic response in terms of the percentage of Ph chromosome positive metaphases in bone marrow is defined as follows:~Complete* (0% Ph-positive cells) Partial* (1-34%) Minor (35-95%) None (96-100%)."|At 6 and 12 months during phase II|||Participants|||Number
177692|NCT00014495|Primary|Maximum Tolerated Dose|The maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195 following cytarabine in patients with advanced myeloid malignancies.|2 years|||mCi/kg|||Number
177693|NCT00015457|Secondary|Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo|Self reported duration of effect in weeks.|3 months|Total enrolled less withdrawals. Less one participant who completed the study but who did not yield analyzeable data.||weeks||Full Range|Median
177694|NCT00015457|Primary|Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score|Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.|1-2 month maximal rating|Total enrolled less withdrawals from study. One participant completed the study but did not yield analyzeable data||units on a scale||Standard Deviation|Mean
177695|NCT00014911|Post-Hoc|Serum Creatinine Levels for Participants in the Extended Follow-up Study Phase|Seven participants from US sites were included in the extended follow-up. These participants were monitored yearly from year three post last transplantation (the original end of study follow-up) through August 30, 2010 (up to 9 years post first transplantation), at which point they were transferred to a new protocol (ITN040CT [NCT01309022]). Serum creatinine is a measure of renal function. Normal ranges are from 0.5 to 1.0 mg/dL for females and 0.7 to 1.2 mg/dL for males.|First transplantation through August 30, 2010 (up to 9 years)|Intent-to-Treat||mg/dL||Full Range|Mean
177696|NCT00014911|Post-Hoc|HbA1c Plasma Laboratory Values for Participants in the Extended Follow-up Study Phase|Seven participants from US sites were included in the extended follow-up. These participants were monitored yearly from year three post last transplantation (the original end of study follow-up) through August 30, 2010 (up to 9 years post first transplantation), at which point they were transferred to a new protocol (ITN040CT [NCT01309022]). Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time. (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher)|First transplantation through August 30, 2010 (up to 9 years)|Intent-to-Treat||HbA1c Percentage||Full Range|Mean
177697|NCT00014911|Secondary|Percent of Participants With Detectable Fasting Basal C-Peptide Levels|C-peptide is a substance that the pancreas releases into the bloodstream in equal amounts to insulin, thereby showing how much insulin the body is making. C-peptide secretion is used to measure the function of transplanted islets. Higher levels indicate better islet function. Detectable fasting basal levels of C-peptide secretion are >=0.3 ng/ml.|Two years post first transplantation|Intent-to-Treat||Percent of Participants|||Number
177714|NCT00012298|Secondary|Association Between In2B8 Scan and Positron Emission Tomography Scan Results (Phase I)|Explored using a contingency table and sensitivity and specificity will be calculated using 90% exact confidence intervals.|At week 12||||||
177698|NCT00014911|Secondary|Percent of Participants That Achieved Insulin Independence From First Transplant|Insulin independence: exogenous insulin not required and glycemic control is achieved as defined by maintaining 1) a blood glycosylated hemoglobin (HbA1c) level < 6.5% (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher),2) a blood glucose level after an overnight fast not exceeding 140 mg per deciliter (dL) more than three times in any week (Normal: 70 to 120 mg/dL), and 3)not exceeding a 2-hour postprandial blood glucose level of 180 mg/dL more than four times per week (Normal: <140mg/dL if <=50 years of age, <150 mg/dL for ages 50-60 years and <160 mg/dL for ages 60+)|First transplantation until end of study (up to six years post final transplantation)|Intent-to-Treat||Percent of Participants|||Number
177699|NCT00014911|Secondary|Percent of Participants With Partial Islet Function One Year Post Final Islet Transplantation.|Partial islet function definition: a fasting basal C-peptide level >= 0.3 ng/mL and a continuing need for insulin or suboptimal glycemic control (Note: C-peptide is a substance that the pancreas releases into the bloodstream in equal amounts to insulin, thereby showing how much insulin the body is making). Adequate glycemic control is defined by: 1) a blood HbA1c level <6.5%, 2) a blood glucose level after an overnight fast not exceeding 140 mg/dL more than three times in any week and, 3) a 2-hour postprandial blood glucose level not exceeding 180 mg/dL more than four times per week|One year post receipt of final islet transplantation|Intent-to-treat||Percent of Participants|||Number
177700|NCT00014911|Primary|Percent of Participants That Achieved Insulin Independence With Adequate Control of Blood Glucose Levels at One Year Post Final Islet Transplantation.|Insulin independence: exogenous insulin not required and glycemic control is achieved as defined by maintaining 1.) a blood glycosylated hemoglobin (HbA1c) level < 6.5% (Normal:<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher),2) a blood glucose level after an overnight fast not exceeding 140 mg per deciliter (dL) more than three times in any week (Normal: 70 to 120 mg/dL), and 3)not exceeding a 2-hour postprandial blood glucose level of 180 mg/dL more than four times per week (Normal: <140mg/dL if <=50 years of age, <150 mg/dL for ages 50-60 years and <160 mg/dL for ages 60+)|One year status post participant receipt of final islet transplantation|Intent-to-treat||Percent of Participants|||Number
177701|NCT00014560|Secondary|Serum Markers of Macrophage Activation|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|Day 1 Hours 0,2,4,6,24, day 15 Hours 0,2,4,6,24||||||
177702|NCT00014560|Primary|Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of BsAb 4G7 x 22|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|Day 1-29||||||
177703|NCT00014560|Primary|Clinical Toxicity|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|day 1-29|This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).|||||
177704|NCT00013611|Secondary|New or Recurrent Serious Disease Progression Events or Death|"Number of participants with fatal or non-fatal serious AIDS-related opportunistic disease.~A serious disease progression event is one of the following: progressive multifocal leukoencephalopathy (PML), lymphoma, Kaposi's sarcoma (visceral), AIDS dementia complex (ADC) stage II or higher, toxoplasmosis, histoplasmosis (systemic), cryptococcosis (systemic), disseminated Mycobacterium avium complex (MAC) disease, wasting syndrome, and cytomegalovirus (CMV) disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|||Participants|||Number
177705|NCT00013611|Secondary|CD4+ Cell Count|Mean CD4+ cell count (cells per cubic mm) averaged over follow-up|Every 4 months from randomization through date last known to be alive or November 15, 2008, whichever was earliest .|||cells per cubic mm||Standard Error|Mean
177706|NCT00013611|Secondary|Grade 4 Clinical Events|Grade 4 clinical events were defined as potentially life-threatening events (excluding opportunistic disease) requiring medical intervention.|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|The outcome is the number of participants experiencing at least one grade 4 event.||Participants|||Number
177707|NCT00013611|Secondary|New or Recurrent Disease Progression Events|"Number of participants with fatal or non-fatal AIDS-related opportunistic disease.~AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|||Participants|||Number
177708|NCT00013611|Secondary|All-cause Mortality|Number of participants who died.|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|||Participants|||Number
177709|NCT00013611|Primary|New or Recurrent Disease Progression Events, as Defined, or Death.|"Number of participants with fatal or non-fatal AIDS-related opportunistic disease or death from any cause.~AIDS-related opportunistic disease includes CDC Category C 1993 definition plus the following diseases: Aspergillosis, invasive; Bartonellosis; Chagas disease of the CNS; Herpes zoster, multidermal; Leishmaniasis, visceral; Lymphoma, Hodgkin's; Microsporidiosis (> 1 month's duration); Nocardiosis; Penicillium marneffti, disseminated; Pneumocystis carinii, extrapulmonary; Rhodococcus equi disease."|From randomization to date last known to be alive or November 15, 2008, whichever is earlier|||Participants|||Number
177710|NCT00012298|Secondary|Tumor Response Rate (Phase II)|Calculated by the number of tumor responses divided by the total number of evaluable patients. An exact binomial confidence interval will be calculated.|Assessed up to 5 years||||||
177711|NCT00012298|Secondary|Time to Disease Progression (Phase II)|Estimated using the method of Kaplan-Meier.|From registration to the earliest date documentation of > disease progression, assessed up to 5 years||||||
177712|NCT00012298|Secondary|Survival (Phase II)|Estimated using the method of Kaplan-Meier.|From registration to death due to any cause, assessed up to 5 years||||||
177715|NCT00012298|Secondary|Association Between the Amounts of Tumor Radiation Indicated by the In2B8 Scan and Tumor Response (Phase I)|Assessed using a correlated logistic regression model and generalized estimating equations (GEE). Covariates such as dose level and use of prophylactic cytokines may also be included in this model. A Wilcoxon test will be used to assess the equality of the distributions of the continuous levels of predicted tumor radiation from the In2B8 scans by response.|At week 12||||||
177716|NCT00012298|Primary|Proportion of Patients Who Receive 2 Sequential Doses of Y2B8 Immunotherapy and Are Progression-free (Phase II)|Estimated by the number of successes divided by the total number of evaluable patients. Exact binomial confidence intervals for the true success proportion will be calculated.|At 3 years|Forty-five patients were registered to Dose Level 6 (39 patients registered to the Phase II portion and 6 patients registered to Dose Level 6 in the Phase I portion). Of the 45 patients, 33 patients received 2 sequential doses of Y2B8 and were evaluable for this endpoint.||percentage of participants||95% Confidence Interval|Number
177717|NCT00012298|Primary|Toxicity of Single-dose Y2B8 Radioimmunotherapy With and Without the Use of Growth Factors (Phase I)|Evaluated using the Common Toxicity Criteria (CTC) version 2.0. This data is presented as the number of patients reporting grade 3 or higher, grade 4 or higher, or grade 5 adverse events regardless of event attribution.|Assessed up to week 24|All patients that were evaluated for adverse events after at least one cycle of treatment were used in this analysis.||participants|||Number
177718|NCT00012298|Primary|Maximum Tolerated Dose (MTD) of Yttrium Y-90 Ibritumomab Tiuxetan (Y2B8) With and Without Filgrastim (G-CSF) and Interleukin-11 (IL-11) (Phase I)|"This study is a series of 3 single-arm phase-I trials designed to determine the maximum tolerated dose (MTD) of a 2-cycle combination regimen containing Rituxan + Y2B8 radioimmunotherapy with and without the use of G-CSF and IL-11. Trial 1 will determine the Y2B8 MTD in the combined regimen without growth factors. Trial 2 will evaluate the combined regimen with growth factors. Trial 3 starts IL-11 earlier (when platelet count drops below 150000) and reduces the dosing interval to twice weekly.~> Dose-limiting toxicity (DLT) is defined as an adverse event in the second cycle attributed to treatment and meeting the following criteria: Grade 4 ANC or platelet decrease for 14 days, or grade 3 for 28 days, or any other grade 3 Non-Heme event.~> If at any time 2 or more patients (of a maximum of 6) at any dose level experience DLT, then the MTD will be defined as the previous dose level during that trial. The number of patients with a DLT are reported here."|At 8 weeks|DLTs were determined in the second cycle of combined treatment. Only Phase I patients that were evaluated after 2 cycles of treatment are included in this evaluation. Two patients at Dose Level 1, 1 patient at Dose Level 2, 4 patients at Dose Level 3, and 1 patient at Dose Level 5 were not evaluated for MTD.||Patients reporting Dose-Limiting Events|||Number
177719|NCT00012012|Secondary|Distant Metastases||From registration to date of distant mets or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
177720|NCT00012012|Secondary|Pelvic Tumor Control||From registration to date of pelvic tumor failure or last follow-up. Analysis occurs after all patients have been potentially followed for 2 years.||||||
177721|NCT00012012|Primary|Number of Patients With Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)|The second part of this study (second arm) was designed to detect a 40% relative reduction (absolute from 77% to 46%) in the acute grade 3/4 toxicity (excluding grade 3 leukopenia) rate, with the addition of amifostine. A one-sided alpha of 0.05 and 80% power required 16 evaluable patients to detect the hypothesized difference. If ≤ 8 had the toxicity, it would be concluded that adding amifostine decreased this toxicity rate by at least 40%.|From start of treatment to 90 days|All eligible patients||participants|||Number
177722|NCT00012012|Primary|Rate of Acute Grade 3/4 Toxicity (Excluding Grade 3 Leukopenia)|To determine the feasibility and tolerance of extended-field external radiotherapy to the pelvis and para-aortic region and intracavitary irradiation combined with weekly cisplatin using the rate of acute grade 3/4 toxicity rate (excluding grade 3 leukopenia). The first part of this study was designed to determine the acute grade 3/4 toxicity rate (excluding grade 3 leukopenia), to have a starting point for the second part (second arm) of the study.|From start of treatment to 90 days|All eligible patients||percentage of participants||95% Confidence Interval|Number
177723|NCT00011986|Primary|Frequency and Severity of Observed Adverse Effects Assessed by Common Toxicity Criteria Version 2.0||Up to 9 years||||||
177724|NCT00011986|Primary|Progression-free Survival|Hazard ratio for progression free survival. All hazard ratios are expressed relative to the reference regimen: Carbo/taxol.|From the date of enrollment to first progression or death or last contact, if alive and progression free.|||months||95% Confidence Interval|Median
177725|NCT00011986|Primary|Overall Survival||Up to 9 years||||||
177726|NCT00010803|Secondary|Progression of Cognitive Decline in Standardized Z-score Scale. Higher Z-scores Indicate Worse Performance.|Rate of annual change by cognitive domain in standardized Z-score scale. Higher Z-scores indicate worse performance. Best score = -2.0 Z-score change per year (improvement); worse score = 2.0 Z-score change per year (decline).|6 months/annually|Final test scores were imputed for participants who did not have a cognitive exam during the year before death (n=234) or dropout (n=154) or during the month before censoring for dementia (n=70). Factors in imputed model included treatment group, demographic and health history variables, study site, and other cognitive scores. Higher Z-scores worse||Z-score units||95% Confidence Interval|Mean
177727|NCT00010803|Secondary|Number of Participants With the Indicated Cardiovascular Disease or Mortality|Myocardial infarction (MI), angina, stroke (CVA), transient ischemic attack (TIA), combined coronary heart disease (CHD) (MI/angina), combined cerebrovascular (CVA/TIA), peripheral vascular disease, and mortality|6 months|Total cohort of 3069 based on same design as primary outcome, ITT.||Participants|||Number
177728|NCT00010803|Primary|Number of Participants With Incident Dementia|All cause dementia based on DSM-IV criteria as determined by an expert panel of clinicians using an adjudication process. A full neuropsychological battery was administered annually, or at 6 month visit if there was a diagnosis of dementia or initiation of medication for dementia by private physician, or change in Modified Mini Mental State Exam (3MSE), Clinical Dementia Rating (CDR), or Alzheimer Disease Assessment Scale (ADAS-Cog). Decline on tests scores based on an algorithm resulted in a neurological exam and brain imaging. These data were used in the adjudication process.|Brief neuropsychological testing every 6 months, detailed testing annually, average 6.1 years follow up|Subjects developing incident dementia during trial in each group, intention to treat (ITT).||Participants|||Number
177729|NCT00010439|Secondary|Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy.|Participants (pts) with fractures bef.and aft.therapy; pts analysed for average changes in mineral apposition rate (MAR) (high (1.9um/day) to near normal (1.2 um/day)as revealed in bone biopsies. MAR is the distance between the two tetracycline labels (um/day). The data represent the average of 10-17 measurements of the disltance obtained by reading 2-7 individual slides of bone biopsy and pts analysed for average insignificant biochemical markers (serum bone specific alkaline phosphatase for bone formation and urinary N-telopeptide for resorption)to determine the effect of therapy.|Before and 12 months after treatment with alendronate|Per protocol||participants|||Number
177730|NCT00010439|Primary|Number of Participants With Increased Bone Mineral Density|Number of participants with increase in bone mineral density at Lumbar Spine and/or Hip at 12 months as compared to the bone mineral density at Lumbar Spine and/or Hip obtained before therapy (baseline values)|at 12 months|per protocol||participants|||Number
177731|NCT00010257|Secondary|Duration of Response|Time from first satisfaction of response criteria to onset of disease progression, assessed using RECIST criteria|assessed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter|Number of participants achieving a complete or partial response by RECIST criteria||Months||95% Confidence Interval|Median
177732|NCT00010257|Primary|Best Overall Response by RECIST Criteria (Version 1.0)|Number of eligible, treated participants in each response category by RECIST criteria|Assessed every 2 cycles (6 weeks)|Analysis population included all eligible participants who received at least 1 dose of the protocol treatment||Participants|||Number
177733|NCT00009737|Secondary|Number of Participants With Any Adverse Events and Serious Adverse Events|An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.|Up to Week 29|The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment||Participants|||Number
177734|NCT00009737|Secondary|Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters|Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.|Up to Week 25|The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.||Participants|||Number
177735|NCT00009737|Secondary|Mean Change From Baseline in Global Health Status at Week 25|Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.|Baseline (Days -7 to 1) and at Week 25|The safety population included all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment (adverse events, laboratory test results, or vital signs).||Score on a scale||Standard Error|Mean
177736|NCT00009737|Secondary|Overall Survival|Participants with overall survival were reported. Overall survival was assessed as the number of days between randomization and death or the last time at which a participant was known to be alive (censoring time).|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.||Participants|||Number
177737|NCT00009737|Secondary|Relapse-Free Survival|Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.||Participants|||Number
177738|NCT00009737|Primary|Disease-free Survival|Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).|Approximately 3 years|All randomized population included all participants who were randomized to one of the two treatment arms, regardless of whether they received any study medication.||Participants|||Number
177739|NCT00008385|Secondary|5-year Overall Survival Rate|Overall survival (OS) was defined as the time from randomization to death due to any cause. Cases without death had been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year OS rate.|Assessed annually for 5 years after randomization|All randomized patients||proportion of participants||95% Confidence Interval|Number
177740|NCT00008385|Secondary|5-year Progression-free Survival Rate|"Progression-Free Survival (PFS) was defined as the time from randomization to second primary lung cancer or recurrence. Cases without events have been censored at the time of last known alive. Kaplan-Meier method was used to estimate 5-year PFS rate.~Accurate determination of whether a cancer occurrence is recurrence or whether it is a second primary is critical. All suspicious lesions identified clinically and/or radiographically were verified histologically. Patients with at least one of the following is considered as having second primary lung cancer.~Different histologic type~Location in different lobe~Location in contralateral lung~Occurrence > 5 years after initial diagnosis"|Assessed annually for 5 years after randomization|All randomized patients||proportion of participants||95% Confidence Interval|Number
177742|NCT00008138|Primary|Progression-Free Survival|Progression was defined as a CA-125 value that is both twice the nadir since registration and greater than 70 units/ml, and is confirmed by a second determination at least 7 days apart, or appearance of any new lesion/site. Symptomatic deterioration was defined as a global deterioration of health status requiring removal from protocol treatment. Progression-Free Survival was defined as the time from the date of registration to the date of progression, symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at last contact date.|Monthly during protocol treatment, then every 3 months up to the end of Year 1, then every 6 months for the next two years, then annually up to Year 5.|Only eligible patients were included in the analysis.||months||95% Confidence Interval|Median
177743|NCT00008138|Primary|Overall Survival|Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.|assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5|Only eligible patients were included in the analysis.||months||95% Confidence Interval|Median
177744|NCT00007644|Primary|All Cause Mortality|Bi-annually, from date of randomization until the date of death from any cause, assessed up to 8 years.|bi-annual|||percentage of participants||95% Confidence Interval|Number
177745|NCT00007644|Primary|All Cause Mortality|Annually, from date of randomization until the date of death from any cause, assessed up to 8 years.|Annual||||||
177746|NCT00007475|Secondary|Determine Whether Renal Transplantation in Patients Whose Elevated FPF Levels Have Been Reduced for a Sustained Period is Associated With a Reduced Prevalence of Recurrent FSGS.|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.~Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:~Terry Phillips at NIH developed an assay that looked promising prior to his retirement.~Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study|Participants whose post-transplantation follow-up yields 1 or more assayed FPF levels|||||
177747|NCT00007475|Secondary|Correlate the Effect of Immunosuppressive Agents Which Reduce Proteinuria in Recurrent FSGS With the Effect on FPF Levels|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.~Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:~Terry Phillips at NIH developed an assay that looked promising prior to his retirement.~Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study|Participants with FPF levels assayed following immunosuppressive therapies (currently none). Note: its assay had not yet been developed to an extent that it could be applied beyond the provisional values assayed for 3 of the first 4 enrollees using a version implemented by Dr.Virginia Savin, VA Medical Center/Kidney Institute, Kansas City, Missouri|||||
177748|NCT00007475|Secondary|Define the Kinetics of FPF in FSGS Patients Receiving Immunomodulatory Therapy or Plasma Exchange.|"Provisional assay of a molecular identification of FPF (current candidate: cardiotrophin-like cytokine 1) using an isolation approach based on sequential precipitation results in a 100-fold purification.~Note: Focal segmental glomerulosclerosis Permeability Factor (FPF) assay had not yet been developed to an extent that it could be applied to all enrollees in the current trial; provisional values were assayed for 3 of the first 4 enrollees using a version implemented by Dr. Virginia Savin, whose lab is actively investigating the above isolation approach, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF, mentioned here for interested readers of this trial report, include:~Terry Phillips at NIH developed an assay that looked promising prior to his retirement.~Avi Rosenberg, NCI has developed promising ELISA-style assay, and mass spectrometry assay, being refined."|End of study|||1- albumin glomerular permeability ratio||Full Range|Mean
177749|NCT00007475|Secondary|Comparison of RNA Expression Profiles in PBMC From Patients With FPF, Without FPF and Control Subjects|"No RNA expression profiles have been obtained as FSGS Permeability Factor (FPF) levels NOT available -- its assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial.~Note that provisional values (targeting current candidate molecule: cardiotrophin-like cytokine 1) were assayed for 3 of the first 4 enrollees using assay by Dr. Virginia Savin, whose lab is actively investigating a molecular identification of FPF using an isolation approach based on sequential precipitation results in a 100-fold purification, but the fraction remains a complex mixture on SDS-PAGE (Sharma 1999). Other investigators of FPF include:~Terry Phillips at NIH developed an assay that looked promising but after his retirement it has not been possible for other researchers to get this working.~Avi Rosenberg, NCI has developed a promising ELISA-style assay, as well as some work in a mass spectrometry assay, and this is being further refined."|End of study|Participants with FPF, without FPF and control subjects who have also had RNA expression profiling done in PBMCs.|||||
177750|NCT00007475|Primary|Reduction in Proteinuria in Recurrent FSGS Following Renal Transplant With Plasma Exchange and Cyclophosphamide.|"Outcomes for FSGS occurring in native kidneys:~A. Complete remission: proteinuria <0.3 g/d ; B. Partial remission: proteinuria between 0.3 and 2 g/d ; C. Incomplete response: proteinuria between 2 and 3.5 g/d ; D. Relapse: return to proteinuria ≥3.5 g/d ; Note that counts within each category A-D may be summarized relative to remaining categories, as a proportion (relative to complement of the whole group count) with calculations implicitly based on zero/one valued binary variables, whose means are proportions, so to report 95% confidence intervals calculated using an exact binomial distribution."|every 3 months up to a year followed with native kidneys|all participants, regardless of amount of follow-up||proportion of participants with outcome||95% Confidence Interval|Mean
177752|NCT00007345|Primary|Duration of Response (DOR)|DOR is defined as the date response was noted until disease was no longer considered to be responding. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria and the International Working Group Criteria (IWG).Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.|up to 127 months|||Months||Full Range|Median
177753|NCT00007345|Primary|Number of Participants With a Response|A rigorous composite assessment was employed with uni-dimensional measurements of skin and visceral disease sites assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) required clearing of all known disease sites. Partial response (PR) required documented response in skin (≥ 30% per RECIST) or lymph nodes (≥ 50% per the International Working Group (IWG) criteria, with response in both compartments for a determination of PR, IWG guidelines. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Progressive disease (PD) is at least a 20% increase in the sum of the target lesions, or the appearance of one or more new lesions. Lymph node disease was assessed bi-dimensionally using the IWG criteria. Bone marrow involvement, as recommended by IWG criteria, and presence of circulating malignant T-cells ascertained by flow cytometry.|up to 56.5 days|Two participants were excluded. After further analysis it was determined that the participants did not have PTCL but a different form of lymphoma that was not known at the onset of enrollment.||participants|||Number
177754|NCT00006916|Primary|Overall Survival|This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.|From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.||||||
177755|NCT00006903|Secondary|Toxicity of Fulvestrant by Common Toxicity Criteria||During study treatment and up to 30 days after stopping study||||||
177756|NCT00006903|Primary|Clinical Response by RECIST Criteria of Estrogen Receptor Expression||Every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.||||||
177757|NCT00006903|Primary|Clinical Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria Evaluated Every 8 Weeks|"Primary outcome measured according to RECIST v1.0 Best Response:~Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart~Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.~Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required~Stable Disease is any condition not meeting the above criteria.~Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease."|Response was measured every other cycle (every 8 weeks) until disease progression is documented or adverse events preclude further treatment.|Total number eligible and treated participants within groups defined by estrogen receptor status in metastatic tumor.||participants|||Number
177758|NCT00006721|Primary|Overall Survival at 5 Years|Measured from date of registration to date of death due to any cause|0-5 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.||percentage of participants|||Number
177759|NCT00006721|Primary|Overall Survival at 2 Years|Measured from date of registration to date of death due to any cause|0-2 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.||percentage of participants|||Number
177760|NCT00006721|Primary|Progression-free Survival at 5 Years|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-5 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.||percentage of participants|||Number
177761|NCT00006721|Secondary|Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal|Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment|Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 2.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included||Participants|||Number
177762|NCT00006721|Secondary|Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)|Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.|Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.||participants|||Number
177763|NCT00006721|Primary|Progression-free Survival at 2 Years|Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date|0-2 years|All eligible patients who started treatment were included in the analysis. The participants in CHOP alone arm were not assessed due to early closure.||percentage of participants|||Number
177764|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 96||Baseline, Week 96|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||percentage of total lymphocytes||Full Range|Median
177765|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 48||Baseline, Week 48|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||percentage of total lymphocytes||Full Range|Median
177766|NCT00006604|Secondary|Change in CD4 Percent From Baseline to Week 20||Baseline, Week 20|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||percentage of total lymphocytes||Full Range|Median
177767|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 96||Baseline, Week 96|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||cells/mm^3||Full Range|Median
177768|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 48||Baseline, Week 48|"Patients accrued to the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||Cells/mm^3||Full Range|Median
177769|NCT00006604|Secondary|Change in CD4 Count (Cells/mm^3) From Baseline to Week 20||Baseline, Week 20|"Participants accrued at the final recommended dose for each group (with evaluable CD4 data).~CD4 changes from baseline were calculated in an ‘as-treated’ analysis’ such that only patients who tolerated the study treatment, and who had evaluable data were included in this analysis."||Cells/mm^3||Full Range|Median
177770|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Clearance (CL/F)|Pharmacokinetics were determined by non-compartmental analysis and Apparent oral clearance (CL/F) was calculated as ATV dose divided by AUC0–24hr.|Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.||L/hr/m^2||Inter-Quartile Range|Median
177771|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Maximum Plasma Concentration (Cmax)|Pharmacokinetics were determined by non-compartmental analysis and Maximum concentration (Cmax) was determined visually.|Week 1 (Day 7) Intensive PK-24 hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.||ng/mL||Inter-Quartile Range|Median
177772|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Minimum Plasma Concentration (C24)|Pharmacokinetics were determined by non-compartmental analysis. C24 determined visually, except in the instance when the patient re-dosed the study medication prior to the 24 hour blood draw or the 24 hour level was not obtained, in which case the C24 was calculated from the elimination rate (ke) and the last measured concentration.|Week 1 (Day 7) Intensive PK-24hr (Pre-dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.||ng/mL||Inter-Quartile Range|Median
177773|NCT00006604|Primary|Pharmacokinetic (PK) Parameter: Area Under the Curve (AUC24h)|Pharmacokinetics were determined by non-compartmental analysis and AUC0–24hr calculated by the linear trapezoidal method.|Week 1 (Day 7) Intensive PK-24hr (Pre-Dose, 1, 2, 3, 4, 6, 8, and 12 hours post-dose and the following day at 24-hours post-dose)|Participants with intensive pharmacokinetic (PK) results at the final recommended dose for each group.||ng*hr/mL||Inter-Quartile Range|Median
177774|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 96|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 96|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).~Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."||percentage of participants||95% Confidence Interval|Number
177775|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 48|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 48|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).~Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."||percentage of participants||95% Confidence Interval|Number
177788|NCT00006392|Secondary|Number of Participants With Colorectal Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.||participants|||Number
177776|NCT00006604|Secondary|Percentage of Participants With HIV RNA <400 Copies/mL at Week 24|Over the duration of the protocol, the assay used to determine Plasma HIV RNA levels was transitioned from the Amplicor HIV-1 Assay to the Amplicor HIV-1 Monitor 1.5 UltraSensitive Assay (Roche Molecular Systems, Branchburg, NJ) to finally the Abbott Real time HIV-1 RNA assay. The assays were performed according to the manufacturer’s instructions in a laboratory accredited by the College of American Pathologists and certified by the NIH Virology Quality Assurance (VQA) in the United States, and VQA certified in South Africa.|Week 24|"Participants accrued at the final recommended dose for each group (with evaluable HIV-RNA data).~Virologic response, defined as achieving HIV-RNA < 400 copies/mL and remaining on treatment, was analyzed using an ‘intent-to-treat’ (ITT) approach, in which children who discontinued study treatment for any reason were considered failures."||percentage of participants||95% Confidence Interval|Number
177777|NCT00006604|Primary|Number of Participants Who Died||From study entry up to week 96|Participants accrued at the final recommended dose for each group.||participants|||Number
177778|NCT00006604|Primary|Number of Participants Who Experienced a Safety Endpoint of Interest Attributed to ATV|"Total Bilirubin >= 5.1xULN, ECG Events and Other Grade 3+ toxicities attributed to study treatment.~The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) Toxicity Table (see references in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening, Grade 5=Death. Relationship to study treatment was determined by the study team."|From study entry up to week 96|Patients accrued at the final recommended dose for each group.||participants|||Number
177779|NCT00006478|Secondary|Changes in Quantitative Bcl-2|To evaluate changes in quantitative bcl-2 of the blood and bone marrow prior to and at various time points following the series of idiotype vaccines.|1 year post transplant evaluation and then annually until disease progression||||||
177780|NCT00006478|Secondary|Toxicity|To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting|At each immunization and at study completion||||||
177781|NCT00006478|Secondary|Safety|To evaluate the safety and toxicity of idiotype vaccine with KLH and GM-CSF adjuvant in the post-transplant setting|At each immunization and at study completion||||||
177782|NCT00006478|Primary|Number of Participants With Humoral and Cellular Immune Response|evaluate the humoral immune responses and cellular immune responses to idiotype vaccine with KLH and GM-CSF adjuvant given to patients with follicular lymphoma following high-dose chemotherapy and autologous stem cell transplantation|immune responses will be obtained prior to first immunization (baseline), prior to the 5th, 6th, 7th immunization series and 2 weeks following administration of the 7th immunization series. And then obtained annually until disease progression|NO formal analysis was completed as this trial was halted prematurely. Thirty patients were to be enrolled in the protocol so that 15 patients would be evaluable at the end of the immunization process. Of the 19 patients enrolled on the trial, only 12 went on to complete the vaccine series.||Participants||95% Confidence Interval|Number
177783|NCT00006409|Primary|MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)||Post-3 year intervention|||Minutes of MET-weighted MVPA˙||Standard Error|Mean
177784|NCT00006409|Primary|MET-weighted MVPA: Daily Minutes of Moderate-to-vigorous Physical Activity (MVPA) Weighted by Metabolic Equivalent of Task (MET)||Post-2 year intervention|||Minutes of MET-weighted MVPA˙||Standard Error|Mean
177785|NCT00006392|Secondary|Number of Participants With Serious Cardiovascular Events|Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Cardiovascular events are based on self-report and are not confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.||participants|||Number
177786|NCT00006392|Secondary|Prostate Cancer Free Survival; Lung Cancer-free Survival, Colorectal Cancer-free Survival, Cancer-free Survival, Overall Survival|Participants are seen at the study site every six month for an update of medical events. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation. Other cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues. Deaths include those reported as SAEs as well as non-SAE deaths as this was a prevention trial with older generally healthy men at baseline who were followed for a long time.||participants|||Number
177787|NCT00006392|Secondary|Number of Participants With Any Diagnosis of Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.||participants|||Number
177802|NCT00006184|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|9 years|||Participants|||Number
177803|NCT00006184|Primary|Immune Response|Immune cell depletion is defined as immunosuppression of participants T cells prior to transplant measured by cluster of differentiation 4 (CD4) counts (i.e. cells) > 50 cells per ul.Immune T-cell depletion helps to reduce the ability to reject allogeneic cells in participants and is required for engraftment. Engraftment is the body's ability to accept donor cells.|105 days|This outcome measure was only pre-specified to be measured in the recipient Arm/Group.||Particpants|||Number
177789|NCT00006392|Secondary|Number of Participants With Lung Cancer|Participants are seen at the study site every six month for an update of medical events. Cancer diagnoses are based on participant report. Medical records for non-prostate cancers were collected but they were not pathologically confirmed. If the participant has been diagnosed with prostate cancer, study site visits are once a year. Follow-up was planned for seven to 12 years depending on when the participant was randomized.|Participants are assessed for medical every six months for 7 to 12 years depending on when he was randomized . Upon diagnosis of prostate cancer, updates are annual.|All randomized eligible participants excluding all men from 2 study sites that the DSMC said to exclude due to poor participant/data management and regulatory issues.||participants|||Number
177790|NCT00006392|Primary|Number of Participants With Prostate Cancer|Participants are seen at the study site every six month for an update of medical events. Prostate cancer diagnosis is based on participant report followed by the submission of a pathologic sample to central pathology review for confirmation.|Every six months for 7 to 12 years depending on when the participant was randomized.|All randomized eligible men not at 2 sites for which the DSMC said the data could not be used due to participant and data management issues as well as regulatory problems.||participants|||Number
177791|NCT00006389|Secondary|Progression-free Survival|Progression-free survival was estimated according to the Kaplan-Meier product-limit method|18 months|||months||95% Confidence Interval|Median
177792|NCT00006389|Secondary|Overall Survival|Overall survival was estimated according to the Kaplan-Meier product-limit method.|18 months|||Months||95% Confidence Interval|Median
177793|NCT00006389|Primary|Observed Response Rate.|"All patients had measurable disease and were assessed after 2 cycles of chemotherapy by medical photograph, plain x-ray, CT, MRI or other imaging scans of at least 2.0 cm or greater with conventional techniques or 1.0 cm or greater with spiral CT. Patients were evaluated by RECIST criteria. All measurable lesions, up to 10 “target lesions” were recorded and measured at baseline across the longest diameter (LD). All other non-target lesions were documented as present or absent. Complete Response (CR) was defined as complete disappearance of the tumor, partial response (PR) was defined as at least a 30% decrease of the sum of the LD of the target lesions, using the baseline sum LD as the reference~The observed response rate was defined as the percentage of evaluable patients whose best response is a CR or PR with associated 95% confidence interval."|Best response recorded from the start of treatment until disease progression/recurrence. Assessed every 2 cycles.|The first 15 patients accrued to an Optimal Three-Stage Phase II design. If 3 or more responses are seen then 18 additional evaluable patients will be accrued to the second stage.||Percentage of Participants||95% Confidence Interval|Number
177794|NCT00006305|Secondary|Number of Participants With Death, Myocardial Infarction, or Stroke||five years|Intention to treat analysis (ITT) of the two main effects in the 2x2 factorial design, 1) Revascularization versus Medical Therapy and 2) Insulin Sensitizing (IS) versus Insulin Providing (IP)||participants|||Number
177795|NCT00006305|Primary|Number of Participants With All-Cause Mortality||five years|Intention to treat analysis (ITT) of the two main effects in the 2x2 factorial design, 1) Revascularization versus Medical Therapy and 2) Insulin Sensitizing (IS) versus Insulin Providing (IP)||participants|||Number
177796|NCT00006289|Primary|McGill Pain Questionnaire (MPQ) of Scores After Administration of Test Drugs (Neurotropin or Placebo)|"Assessments of pain severity by the patient using a McGill Pain Questionnaire which consists of 3 major classes of word descriptors-sensory, affective and evaluative - that are used by patients to specify subjective pain experience. Each word chosen from descriptor responses to 20 questions is given a value and the sum of the values of the responses provides a score which is an index of the pain severity with a minimum value of 20 and a maximal value of 78. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators are blinded to the treatment code (drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|MPQ of each patient is measured after each five-week treatment interval with drug A or drug B.|||units on a scale||Standard Error|Mean
177797|NCT00006289|Primary|Numeric Rating Scale (NRS) of Pain Scores After Administration of Test Drugs (Neurotropin or Placebo)|"Assessments of pain severity by the patient using a numeric rating scale ranging from 0 to 10 as a verbal response where 0 = no pain and 10 =maximal pain. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while the investigators are blinded to the treatment code (Drug A or B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|NRS of each patient is measured after each five-week treatment interval with placebo or Neurotropin.|||units on a scale||Standard Deviation|Mean
177798|NCT00006289|Primary|Visual Analogue Scale (VAS) of Pain Scores After Administration of Test Drugs (Placebo or Neurotropin )|"Assessments of pain severity by the patient using a visual analogue scale ranging from 0 to 100 (mm), with 0 = no pain and 100 = maximal pain level. When it is difficult to recruit the patients, the interim analysis using these data is performed after completion of the study of first 16 patients (target number is 30). The data from 16 patients was analyzed while investigators were blinded to the treatment code (Drug A and B) provided by the NIH pharmacy. Only after the analysis was completed was the code unblinded. Placebo or Neurotropin in place of drug A or drug B."|VAS of each patient is measured after each 5-week treatment interval with placebo or Neurotropin.|||mm||Standard Error|Mean
177799|NCT00006237|Secondary|Toxicity|Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event|While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter.|Eligible patients who started therapy||Participants|||Number
177800|NCT00006237|Primary|5-year Relapse-Free Survival|Measured from date of registration to date of first observation of progressive disease or death due to any cause.|Every three months for the first year, every 6 months for years 2-5, annually for years 6-10|||Percentage of population|||Number
177801|NCT00006237|Primary|5-year Overall Survival|Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.|Every three months for a year, every six months for years 2-5, annual for years 5-10|||Percent of population|||Number
177808|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|12 months|Participants with available data at 12mo. All others were unable to provide data at this time point.||percentage of participants|||Number
177809|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|6 months|Participants with available data at 6mo. All others were unable to provide data at this time point.||percentage of participants|||Number
177810|NCT00006170|Primary|Smoking Abstinence|Women were interviewed using the time-line follow-back method and expired-air carbon monoxide (CO) was collected using a Vitalograph BreathCO monitor. Salivary samples were collected immediately after each assessment visit (1, 3, 6, and 12 mo). A CO reading of 8ppm or less and cotinine level of >15 micrograms/L were used to confirm non-smoking.|3 months|Participants with available data at 3mo. All others were unable to provide data at this time point.||percentage of participants|||Number
177811|NCT00006164|Primary|Hepatic Encephalopathy|Any mental status alteration which is deemed by the investigator to be due to portosystemic encephalopathy, whether occurring during a provoked episode (GI bleeding, diuretics, usual sedative doses), or spontaneously (without apparent cause).|1400 days (3.85 years) post randomization|||participants|||Number
177812|NCT00006164|Secondary|Quality of Life|To measure health-related quality of life (HRQOL), we administered the highly reliable and validated Short Form Health Survey (SF-36) 43 at annual study visits.|1400 days (3.85 years) post randomization||10/2010||||
177813|NCT00006164|Secondary|Presumed Hepatocellular Carcinoma (HCC)|"Presumed HCC was considered when histology was not available and alpha-fetoprotein (AFP) is <1000 ng/ml, if:~A new hepatic lesion was shown on ultrasound and 1 additional imaging showed a hepatic lesion with characteristics of HCC.~AFP>ULN (upper limit of normal) and 2 imaging studies showed a hepatic lesion with characteristics of HCC.~A progressively enlarging hepatic lesion starting as a new defect resulting in patient death.~A new hepatic defect with at least 1 characteristic scan and:~Increase in size over time or~Increasing AFP rising to a level of >200 ng/ml"|1400 days (3.85 years) post randomization||10/2010||||
177814|NCT00006164|Secondary|Changes in Fibrosis From Baseline at Year 2 or Year 4 Biopsy.|For patients with noncirrhotic fibrosis at baseline, any change in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)|1400 days (3.85 years) post randomization||10/2010||||
177815|NCT00006164|Secondary|Events Requiring Dose Reductions (in Both Treatment Groups).|"Reduction in the dose of peginterferon alfa-2a factors:~Disabling symptoms, which, in the opinion of the investigator, were related to peginterferon alfa-2a treatment and prevented the patient from performing his/her occupation or daily tasks.~A rash consistent with allergic reaction or vasculitis.~Reductions in the platelet count according to protocol guidelines.~A reduction in neutrophil count according to protocol guidelines.~Any adverse reaction, which, in the opinion of the investigator, placed the patient at increased risk."|1400 days (3.85 years) post randomization||10/2010||||
177816|NCT00006164|Secondary|Serious Adverse Events|"A serious adverse event (SAE) is an untoward medical occurrence that results in any of the following:~Death~Is life threatening (risk of death at the time of the event)~Requires in-patient hospitalization or prolongation of existing hospitalization~Results in persistent or significant disability/incapacity~Congenital abnormality or birth defect~Trial outcomes (except death) were not considered serious adverse events."|1400 days (3.85 years) post randomization|||participants|||Number
177817|NCT00006164|Primary|Spontaneous Bacterial Peritonitis|Any episode of spontaneous ascitic infection diagnosed on the basis of elevated neutrophil count (> 250/ml) in paracentesis fluid or positive bacterial cultures and clinical diagnosis in the absence of white blood cell (WBC) availability.|1400 days (3.85 years) post randomization|||participants|||Number
177818|NCT00006164|Primary|Ascites|"Any abdominal fluid which is:~Mild, moderate or marked on ultrasound; or~Progressive on serial physical examinations; or~Requires diuretic therapy. To meet the definition of ascites, abdominal fluid that is “mild” (“barely detectable”) on physical examination requires ultrasound confirmation that is “mild”, “moderate” or “marked” ascites. Ultrasound reports of minimal fluid around the liver do not meet the definition."|1400 days (3.85 years) post randomization|||participants|||Number
177819|NCT00006164|Primary|Variceal Hemorrhage|A gastrointestinal hemorrhage which is believed by the investigator to be due to bleeding esophageal or gastric varices. In general, an endoscopy will have been performed and will have revealed either direct evidence of variceal bleeding (bleeding varix, red wale sign) or historical evidence for significant upper gastro-intestinal bleeding plus upper endoscopy revealing moderate varices and no other site of bleeding is identified|1400 days (3.85 years) post randomization|||participants|||Number
177820|NCT00006164|Primary|Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits|Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater hepatic decompensation)|1400 days (3.85 years) post randomization|||participants|||Number
177821|NCT00006164|Primary|Development of Hepatocellular Carcinoma (HCC)|"A diagnosis of development of hepatocellular carcinoma (HCC) was based on either~Histology showing HCC (from a biopsy, surgery, or autopsy) or~A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to > 1,000 ng/ml."|1400 days (3.85 years) post randomization|||participants|||Number
177822|NCT00006164|Primary|Death From Any Cause||1400 days (3.85 years) post randomization|||participants|||Number
177823|NCT00006164|Primary|Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies|For patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization)|1400 days (3.85 years) post randomization|||participants|||Number
177824|NCT00006164|Primary|Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points|Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study|1400 days (3.85 years) post randomization|||participants|||Number
177825|NCT00006156|Secondary|Follicle Stimulating Hormone Stimulated Serum Estradiol (E2) Levels||24 hours|||participants||Standard Error|Mean
177826|NCT00006156|Primary|Follicle Stimulating Hormone Stimulated Serum Inhibin B Levels.||24 hours|||participants||Standard Error|Mean
177827|NCT00006151|Primary|Abstinence Rate|The main outcome measures were rates of treatment completion and smoking abstinence. It was hypothesized that the nicotine blocking agent product would lead to higher treatment completion rates, higher abstinence rates, and fewer problems with withdrawal than the placebo group.|1 year|||participants|||Number
177828|NCT00006011|Primary|Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.|"Recurrence is defined as discovery of disease not previously present by clinical, radiographic, and/or laboratory means or as a 50% or greater increase in the product of two perpendicular diameters from any documented lesion.~Recurrence-free survival is defined as time in months the patient is alive, recurrence-free starting from the date of randomization.~Intention to treat among eligible participants who receive random treatment allocation."|study entry up to 5 years post treatment|||participants|||Number
177829|NCT00005957|Secondary|Disease-free Survival|Disease-free survival (including locoregional and distant disease)|10 years|Intention-to-treat||percentage of disease-free at 10 years||95% Confidence Interval|Number
177830|NCT00005957|Primary|Overall Survival|Duration of study|10 years|Intention-to-treat||percentage of alive at 10 years||95% Confidence Interval|Number
177831|NCT00005947|Secondary|Overall Survival|Overall Survival|From randomization to 36 months|||Months||95% Confidence Interval|Median
177832|NCT00005947|Primary|Time to Objective Disease Progression|The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).|36 months from randomization|all randomized participants||Weeks||95% Confidence Interval|Median
177833|NCT00005937|Primary|Red Blood Cell Transfusion Independence|Red blood cell transfusion independence was documented as time from last transfusion of red cells to last day of transfusion free follow-up. Independence or response to the intervention was assessed by weekly blood counts. Transfusion independence was defined as no transfusion requirement for a 3 month period. Complete hematologic response is defined as the normalization of affected cells lines and less than 5% marrow blasts present. Partial hematologic response is defined as greater than 50% improvement from baseline to normal levels of all cell counts and greater than 50% decrease in marrow blasts.|6 months|||participants|||Number
177834|NCT00005908|Primary|Number of Participants, e.g. Responders and Non-responders With a Percent Change in Expression Patterns After Chemotherapy With Changes in Expression Patterns After Chemotherapy in Preclinical Models|Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.|6 years|"Specimens from 21 patients. Analysis was per protocol and included only those patients with adequate RNA (ribonucleic acid) for analysis. Since both had the same intervention, the sample size was small, and a dose response was not expected, all patients were analyzed together."||Participants|||Number
177835|NCT00005908|Primary|Complementary Deoxyribonucleic Acid (cDNA) Expression|Patients were classified as responders or non-responders based on change in tumor size by clinical exam and pathologic response.For instance, patients with a pathological complete response, micro-invasive disease at surgery, or clinical complete response after four cycles of treatment were considered responders. Changes in gene expression associated with treatment was assessed before/after chemotherapy. All gene expression summary intensities below 50 were thresholded to the value of 50 and genes showing variability significantly smaller than the median gene variability were screened out.|6 years|||Participants|||Number
177836|NCT00005908|Primary|Overall Clinical Response Rate|Overall response rate is defined as the percentage of participants with a CR (complete disappearance of all target lesions), PR (a 30% decrease in the sum of the longest diameter of target lesions) determined by clinical measurements per the Response Evaluation Criteria in Solid Tumors (RECIST) and/or a complete pathologic response (disappearance of all invasive tumor pathologically or presence of ductal carcinoma in situ) per the Chevallier criteria. For details about the RECIST or Chevallier criteria see the protocol link module.|6 years|Combined data from 2 dose levels in 29 evaluable patients.||Percentage of participants|||Number
177837|NCT00005908|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|6 years|||Participants|||Number
177838|NCT00005906|Secondary|Number of Participants With Liver Function Abnormalities|"One or more abnormality of the following liver function tests:~Alkaline phosphatase above 116 i.u.~SGPT above 41 i.u.~SGOT from 34 i.u.~Total bilirubin above 1.0 mg/dl"|Six months|||Participants|||Number
177839|NCT00005906|Primary|Number of Participants With a Reduction of Pain/Symptoms as Measured by a Simple Numeric Symptom Distress Scale (NDS) to Rate the Severity of Individual Symptoms.|"Octreotide treatment will be considered successful if the reported pain/symptom score is reduced by at least 2 levels at termination of treatment.~A simple visual numeric distress scale ranging from zero to 10 will be employed to rate the severity of individual symptoms. The best score is zero, which means absence of symptoms and the maximal is 10, meaning that the symptoms are very severe."|Six months|Four patients with lymphangioleiomyomatosis and lymphangioleiomyomas and chylous effusions treated with octreotide injections by the subcutaneous route to determine whether the size of the tumors and effusions decrease with the therapy||Participants|||Number
177841|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 6 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
177842|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 36 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
177843|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 30 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
177844|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 24 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
177845|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 18 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
177846|NCT00005901|Primary|Change in Bone Mineral Density in Response to Pamidronate|Dual-energy X-ray Absorptiometry (DXA) measurements were obtained using a Hologic QDR 4500 densitometer and low density software package. Measurements have a precision of 0.011 SD. Raw measurements were converted to Z-scores for analysis using the manufacturer's reference standards for age and pubertal status.|Baseline vs. 12 months after first dose|All subjects received Pamidronate for 3 years.||Z-score||Standard Deviation|Mean
177847|NCT00005669|Secondary|Change in Body Fat by Bod Pod|Change in body fat mass measured by air displacement plethysmography (kg)|6 months|||kg||95% Confidence Interval|Mean
177848|NCT00005669|Secondary|Change in Body Fat by DEXA|Change in body fat mass by Dual Energy X-Ray Absorptiometry (kg)|6 months|ITT, multiple imputation model for missing data under a missing-at-random assumption||kg||95% Confidence Interval|Mean
177849|NCT00005669|Secondary|Change in Body Weight|Change in body weight (kg)|6 months|||kg||95% Confidence Interval|Mean
177850|NCT00005669|Secondary|Change in Body Weight as Determined by BMI|Change in body weight as determined by body mass index (kg/m2)|6 months|||kg/m2||95% Confidence Interval|Mean
177851|NCT00005669|Primary|Changes in Body Weight as Determined by Body Mass Index-standard Deviation Score (BMI-SDS).|Change in Body Mass Index standard deviation score (BMI-SDS) determined using tables created by the CDC in 2000. BMI-SDS is a unitless transformation of the body mass index (measured in kg divided by the squared height in meters) using the L M S method. Possible values range from -3 to +3. See http://www.cdc.gov/growthcharts/percentile_data_files.htm for details.|6 months|||Units on a scale||95% Confidence Interval|Mean
177852|NCT00004980|Secondary|Responder Status|"Responder defined as a participant who attains an endpoint hallucination change score (HCS) of 5 or lower after 9 active/shame rTMS sessions.~Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline"|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|LOCF||Participants|||Number
177853|NCT00004980|Secondary|Clinical Global Improvement (CGI) Scale After 9 Active/Shame rTMS Sessions|Scaled from 1-7 as follows: 1=dramatically improved, 2=moderately improved, 3=minimally improved, 4=no change, 5=minimally worsened, 6=moderately worsened, 7=dramatically worsened|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|||Units on a scale||Standard Deviation|Mean
177854|NCT00004980|Secondary|Change From Baseline in Hallucination Frequency After 9 Active/Shame rTMS Sessions|Difference between baseline hallucination frequency and hallucintion frequency at last assessment. Assessed on the basis of a 0-9 scale, with higher scores being more severe.|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|LOCF||Score on a scale||Standard Deviation|Mean
177855|NCT00004980|Primary|Hallucination Change Score (HCS) After 9 Active/Sham rTMS Sessions|Change in hallucination severity relative to baseline with scores ranging 1 in unit intervals to 20 anchored as follows: 0=hallucinations stopped, 10=no change, 20=hallucinations twice as severe as baseline|After the 9th active/sham rTMS session (up to 2 weeks or end of intervention)|Last Observation Carried Forward (LOCF)||Units on a scale||Standard Deviation|Mean
177856|NCT00004978|Secondary|Hepatic, Metabolic, and Cardiac Conditions|"Number of participants experiencing a serious non-AIDS event defined as first serious cardiovascular, renal, or hepatic event, or non-AIDS malignancy."|From randomization through study end - median of 7.6 years follow-up|||participants|||Number
177857|NCT00004978|Secondary|Pattern of Use of Prophylaxis for Opportunistic Infections|Number of participants using pneumocystis pneumonia (PCP) prophylaxis at the last attended followup visit.|last followup visit - median of 7.6 years follow-up|Intention to treat (ITT) - Medication use recorded on the last followup visit attended among all participants attending at least one followup visit.||participants|||Number
177858|NCT00004978|Secondary|Grade 4 Signs and Symptoms|Participants with at least one grade 4 sign or symptom (except those limited to a laboratory measurement), other than AIDS-defining conditions. Events were graded according to a standardized toxicity table. Events not specifically contained in the toxicity table were considered Grade 4 if they resulted in extreme limitation in activity or required significant medical intervention/therapy, hospitalization or hospice care. Grade 4 events by type are given under the adverse events section.|From randomization through study end - median of 7.6 years follow-up|||Participants|||Number
177862|NCT00004978|Secondary|Participants With a New Disease Progression Event or Death|Includes first new episode of: CDC Category C 1993 AIDS-defining events plus invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease|from randomization through 15 November 2008 - median of 7.6 years follow-up|||participants|||Number
177863|NCT00004978|Secondary|Number of Participants Who Died From Any Cause||from randomization through study end - median of 7.6 years follow-up|||participants|||Number
177864|NCT00004978|Secondary|New or Recurrent Serious HIV Disease Progression Event Including Death|Patients with at least one: progressive multifocal leukoencephalopathy, lymphoma, visceral Kaposi's sarcoma, AIDS dementia complex, toxoplasmosis, histoplasmosis, cryptococcosis, Mycobacterium avium complex, wasting syndrome, and cytomegalovirus disease.|from randomization through study end - median of 7.6 years follow-up|ITT||participants|||Number
177865|NCT00004978|Primary|New or Recurrent HIV Disease Progression Event Including Death|Participants who die or experience at least one: any CDC Category C 1993 AIDS-defining events or one of the following: invasive aspergillosis, bartonellosis, Chagas disease, Herpes zoster, visceral Leishmaniasis, Hodgkin's lymphoma, non-Hodgkin's lymphoma (all cell types), microsporidiosis, nocardiosis, disseminated Penicillium marneffii, extrapulmonary Pneumocystis carinii, and Rhodococcus equi disease|from randomization through study end - median of 7.6 years follow-up|ITT||participants|||Number
177866|NCT00004888|Secondary|Duration of Response|Defined as time from onset of PR or CR, whichever occurred first, until objective evidence of progression.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|Responders||Months||95% Confidence Interval|Median
177867|NCT00004888|Primary|Summary of Left Ventricular Ejection Fraction Values|This table summarizes the LVEF information at baseline, post Cycle 4, post Cycle 8, and 30 or more days after Cycle 8 on all treated patients and on the eligible subset. LVEF drops reported are absolute (not relative) drops.|Baseline, after cycle 4, after cycle 8, and 30 or more days after last cycle of induction therapy.|All treated patients||LVEF percent||Standard Deviation|Mean
177868|NCT00004888|Secondary|Progression-Free Survival|Progression-Free Survival was defined as time from study entry to progression or to death without documentation of progression. A progression is defined as a significant increase in size of lesions present at the start of therapy or after a response.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|All eligible patients were included in this analysis. Please note that 2 patients on Arm B died without documentation of progression. Also, 4 patients died or were taken off treatment before follow-up evaluations, and PFS was censored at zero.||months||95% Confidence Interval|Median
177869|NCT00004888|Secondary|Overall Survival||Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of November 21, 2007 is used for this report.|All eligible patients were included in this analysis.||months||95% Confidence Interval|Median
177870|NCT00004888|Secondary|Best Overall Response Using Eastern Cooperative Group Solid Tumor Response Criteria.|Please note that overall response includes CR and PR. CR is defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. PR is greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. No change is defined as no significant change in measurable or evaluable disease for at least 4 weeks. Progression is defined as a significant increase in size of lesions present at the start of therapy or after a response.|Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually until death or until reaching full study stop date. Data as of Nov 21, 2007 is used for this report. Please note that best overall response is reported in the table.|Eligible Patients||participants|||Number
177871|NCT00004888|Primary|Grades of Cardiotoxicity Events in the Subset of Patients Reporting a Cardiotoxicity Event|This table summarizes the cardiotoxicity events of different grades. Grade 1 is a decline of left ventricular ejection fraction(LVEF) >=10% but <20% of baseline value. Grade 2 is LVEF below LLN (50%) or decline of LVEF >=20% of baseline value. Grade 3 is congestive heart failure responsive to treatment. Please note that only a subset of patients reported cardiotoxic events so the totals will not add up to the total number of participants.|Baseline, after cycle 4 (~84 days), after cycle 8 (~168 days), and 30 or more days after last cycle of induction therapy|Treated patients who had a cardiotoxicity event||participants|||Number
177872|NCT00004859|Primary|Overall Survival Time|Survival time is defined as time from study entry to death from any cause|every other month until 24 months from study entry, then every 3 months for year 3, every 4 months for year 4 and every 6 months for year 5|intent to treat analysis in the 546 eligible patients||Months||95% Confidence Interval|Median
177873|NCT00004859|Secondary|Response Rate at Best Response to Treatment|Proportion of patients with complete or partial response using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.0. Complete response is defined as the complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response is defined as greater than or equal to 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease.|every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year|||Proportion of participants||95% Confidence Interval|Number
177874|NCT00004859|Secondary|Time to Disease Progression|Time to disease progression is defined as the time from randomization to documented disease progression or to death without progression. Patients without documented progression or death reported were censored at the time of the last documented disease evaluation. Progression is defined, using the Response Evaluation Criteria In Solid Tumors (RECIST), as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.|every other month until 24 months from study entry, every 3 months for year 3, every 4 months for the 4th year and every 6 months for the 5th year|||Months||95% Confidence Interval|Median
177906|NCT00004092|Secondary|Five-Year Overall Survival|Patients who were still alive were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.|Five Years|||percentage of participants||95% Confidence Interval|Number
177875|NCT00004732|Secondary|Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke).|4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.|4 years|||Proportion||Standard Error|Mean
177876|NCT00004732|Primary|Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke|4-year follow-up, proportions reflecting the absolute efficacy of carotid-artery stenting (CAS) over that of carotid endarterectomy (CEA) were based on Kaplan-Meier survival estimates at the end of the 4 years.|4 years|||Proportion||Standard Error|Mean
177877|NCT00004635|Secondary|The Number of Participants With Adverse Events|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|60 months|||participants|||Number
177878|NCT00004635|Primary|Time to Progression|Time to progression is defined as follows: if the PSA returns to baseline (defined as the PSA value prior to starting leuprolide or goserelin) or increases to the absolute value of 5 ng/ml.|36 months|Per protocol. First intervention phase-73 participants (thalidomide) were analyzed and 0 was excluded; 74 participants were analyzed (placebo) and 1 was excluded for discrepancy in data entry. Crossover phase-50 participants were analyzed (thalidomide)and 1 was excluded for discrepancy in data entry, 38 participants for placebo and 0 excluded.||months||95% Confidence Interval|Median
177879|NCT00004563|Secondary|DLCO|diffusing capacity of the lungs for carbon monoxide|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.||% of predicted||Standard Error|Mean
177880|NCT00004563|Secondary|Total Lung Capacity|expressed as a percentage of the predicted value|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.||% of predicted||Standard Error|Mean
177881|NCT00004563|Primary|Forced Vital Capacity|The primary end point was the forced vital capacity (FVC, expressed as a percentage of the predicted value) at 12 months, after adjustment for the baseline FVC.|12 months|The Number of Participants Analyzed is not consistent with the Participant Flow for the following reason: a number of the patients who withdrew, had treatment failure, or died had completed at least the six-month visit--for these patients, a generalized estimating-equation regression model was fitted, and data missing at 12 months were imputed.||% of predicted||Standard Error|Mean
177882|NCT00004562|Secondary|Number of Participants With Secondary Outcomes (Safety Events)|Number of Participants with Secondary Outcomes (death from any cause, nonfatal MI, class IV HF, cardiac death, occurrence of selected clinical outcomes including stroke, hospitalization for CHF, sustained ventricular tachycardia/ventricular fibrillation, ICD implantation, or the composite end point). Events were centrally adjudicated.|Measured over a maximum 9-year follow-up period - 6 year median|||participants|||Number
177883|NCT00004562|Primary|Number of Patients That Had a First Occurrence of the Primary End Point (Composite of Death From Any Cause, Nonfatal MI, or Class IV HF)|Number of Patients with Events (death from any cause, nonfatal reinfarction, and hospitalization for New York Heart Association (NYHA) Class IV congestive heart failure). Events were centrally adjudicated.|Measured over a maximum 9-year follow-up period - 6 year median|||participants|||Number
177884|NCT00004547|Secondary|Signal Transduction Pathways in Tumor Tissue Versus Normal Tissue|Signal transduction pathways were measured using reverse phase protein lysate microarray to determine if the pathways are distinct in tumor versus normal tissue.|once during surgery|This outcome measure was not analyzed because it was not feasible.|||||
177885|NCT00004547|Secondary|Quality of Life Questionnaire Score|"The Short-Form-36 Health Survey (SF-36) and the Functional Assessment of Cancer Therapy Disease Specific for Colorectal Cancer (FACT-C) will be given to the patients upon admission preoperatively, then 6 weeks postoperatively, and then 3, 6, 9, and 12 months for the first year and then every 6 months until the patient goes off study. These forms summarize a participants positive and negative aspects that characterize one's psychological (emotional(, physical, and social well-being at a point in time.~For detailed information about the questionnaires, please see the Protocol Link module."|preop, 6 weeks postop and then 3, 6, 9, and 12 months the first year and then every 6 months until the patient is off study|This outcome measure was not evaluated due to poor patient compliance.|||||
177886|NCT00004547|Secondary|Percentage of Participants Who Had Paclitaxel and 5-fluorouracil (5-FU) Analysis Performed|Paclitaxel and 5-FU levels in plasma and perfusate will be determined by standard high-performance liquid chromatography (HPLC). Samples will be collected just prior to (Time 0) the infusion of the intraperitoneal dwell of 5-FU and paclitaxel, at the following time intervals after the conclusion of the intraperitoneal dwell infusion (15 minutes, 1 hour, 6 hour, 12 hour, 24 hour, 48 hour).|Perioperative day 7-12 after surgery|This outcome measure was not analyzed because it was not feasible (e.g. inadequate samples).|||||
177887|NCT00004547|Primary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|only assessed during the perioperative period (i.e. up to 90 days following surgery)|188 participants is consistent with the total number of participants analyzed (e.g. total from each column in participant flow, 83 P. Meso + 48 L. Grade + 57 Adeno. = 188).||Participants|||Number
177888|NCT00004547|Primary|Number of Participants With a Response|Response is assessed by measuring the time to clinical or radiographic recurrence of disease. Patients will be followed with computed tomography (CT) scans. At any time point where there is evidence of progressive disease in the peritoneal cavity (imageable tumor nodules or new onset of ascites) the patients will be scored as failing within the abdominal cavity.|Patients were assessed every three months for one year and then every 6 months|||Participants|||Number
177889|NCT00004547|Primary|Number of Participants With Disease-free Survival|Participants who achieve either a six or twelve month disease free interval based on radiographic imaging and symptoms.|On study date until the first scan with imageable disease, assessed up to 100 months or more.|This outcome measure was not analyzed because information was not consistently available.|||||
177890|NCT00004500|Secondary|Number of Participants With Air Leaks|Includes pulmonary interstitial emphysema (PIE), Pneumothorax, Pneumomediastinium, and Pneumopericardium|28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.~All enrolled infants were analyzed (intent-to-treat)."||participants|||Number
177891|NCT00004500|Secondary|Incidence of Death||28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.~All enrolled infants were analyzed (intent-to-treat)."||participants|||Number
177892|NCT00004500|Primary|Number of Days Receiving Mechanical Ventilation (MV)|A patient is not receiving MV if he/she is removed from the mechanical ventilator for ≥ 24 hours. If a patient subsequently requires intubation and MV, the additional time will count as days receiving MV.|28 days|"Data from the initial Phase 1/2 trial were used to estimate the number of subjects required for testing the null hypothesis of no difference between treatment groups. A sample size of 100 subjects per group is required to test the hypothesis at a significance level of 0.05 with a power of 80%.~All enrolled infants were analyzed (intent-to-treat)."||days||Standard Deviation|Mean
177893|NCT00004412|Secondary|% Ulcers Which Completely Healed in Each Group, After 3 Months|Control Arm: given option to crossover to Treatment Arm if, ulcers have not closed after 12 weeks standard local care alone.|two additional courses of 8 week cycles|Per Protocol||percentage of completely healed ulcers|Participants||Number
177894|NCT00004412|Primary|Healing Defined as a Decrease in Ulcer Area by at Least 25% of the Initial Area|"Treatment Arm: The AB is given as an IV infusion at 500 mg/kg over 6-9 hrs. 5 days per week for 12 weeks. After 12 weeks of therapy, if he ulcer has decreased by 25% , the AB may be continued for additional 8 weeks (twice) or, until ulcer closes plus 2 weeks, additionally.~Ulcers photographed, traced, and ulcer areas calculated by computerized planimetry."|participants were followed for an average of 3 months|Per protocol||percentage of healed ulcers|Participants||Number
177895|NCT00004228|Secondary|Percentage of Patients With Overall Survival as Assessed by Time to Death|Overall survival will be computed by measuring the rate of deaths during induction due primarily to treatment toxicity and cumulative incidence of toxic deaths in induction or deaths in remission overall and separately for treatment groups defined by the two design factors.|5 years|There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.||percentage of participants||95% Confidence Interval|Number
177896|NCT00004228|Primary|Event-free Survival|Assessed by time to treatment failure, occurrence of second malignant neoplasm, or death from any cause. Statistical analysis will be to estimate the difference in the proportion of patients treated with each therapy who are long-term event-free survivors due either to the difference between the backbone therapy regimens (CCG BFM vs NHL/BFM-95), or due to the intensification.|5 years|There were 19 total ineligible patients, 4 for A0, 2 for A1, 4 for A2, 1 for B2 (CNS+), 1 for B2 (Disseminated), 2 for B1 (CNS-), and 5 for B1 (NHL additional enrollment) not included in outcome measure analysis.||percentage of particpants||95% Confidence Interval|Number
177897|NCT00004146|Primary|Correlation Between PK CAI and Toxicity in This pt Population|PK paramenters including steady state CAI concentrations with toxicity/or drug activity|during treatment|50 subjects had PK samples for analysis||ug/ml||Standard Deviation|Mean
177898|NCT00004146|Primary|Toxicity of CAI When Combined With RT|patients who experienced a grade 3 or higher event considered at least possibly related to CAI|pts were reviewed for toxicity while on treatement - median time of 2 months|pts were treated for a median time of 2 months (23 days to 46 months). patients who experienced a grade 3 or higher event considered at least possibly related to CAI||participants|||Number
177899|NCT00004146|Primary|Overall Survival Rate|estimated period of time event assessed 30 months. event assessed from time of histological diagnosis to death|approximately 30 months|intent to treat pt population. time from histological diagnosis to death.||months||95% Confidence Interval|Median
177900|NCT00004143|Primary|Number of Participants With Transplant-related Mortality|Number of patients who died due to transplant-related complications|100 days|||participants|||Number
177901|NCT00004143|Primary|Number of Participants With Grade 3-4 Unexpected Adverse Events|An unexpected adverse event is one that differs in the nature, severity, or frequency from (a) the research procedures that are described in the protocol-related documents, (such as the IRB-approved research protocol and informed consent document) as expected, and/or (b) the characteristics of the subject population being studied.|45 days post transplant|||participants|||Number
177902|NCT00004143|Primary|Number of Patients With Grade 3-4 Acute Graft Versus Host Disease (GVHD)|Number of patients with Grade 3-4 acute Graft Versus Host Disease (GVHD). GVHD will be monitored at least two times per week through day 45, then weekly through day 60 and graded by 2 persons at each institution, to ensure internal consistency in grading.|60 days post transplant|||participants|||Number
177903|NCT00004143|Secondary|Overall Survival|Number of patients alive 2 years after transplant|2 years|||participants|||Number
177904|NCT00004143|Primary|Number of Patients With Platelet Engraftment|Number of patients with platelet engraftment - Platelets > 20,000/μL and hemoglobin level remaining above 10 g/dL without transfusion support, with tests showing at least 2.5% donor cells present. Primary graft failure is defined as absence of establishment of adequate donor hematopoiesis by day 42 with bone marrow cellularity < 5%, peripheral White Blood Count (WBC) < 500/μL, peripheral ANC < 100/μL, and/or platelets < 10,000/μL by day 120 with absence of megakaryocytes in the bone marrow (in the absence of disease relapse).|1 year post transplant|||participants|||Number
177905|NCT00004143|Primary|Number of Patients With Neutrophil Engraftment|Number of patients with neutrophil engraftment: Absolute Neutrophil Count (ANC) > 500/μL and hemoglobin level remaining above 10 g/dL without transfusion support, with tests showing at least 2.5% donor cells present. Primary graft failure is defined as absence of establishment of adequate donor hematopoiesis by day 42 with bone marrow cellularity < 5%, peripheral White Blood Count (WBC) < 500/μL, peripheral ANC < 100/μL, and/or platelets < 10,000/μL by day 120 with absence of megakaryocytes in the bone marrow (in the absence of disease relapse).|1 year post transplant|||participants|||Number
177912|NCT00004054|Primary|Overall Survival (5-year Rate Reported)|Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at date of last contact. This analysis was planned to occur when all patients had been potentially followed for 5 years.|From the date of randomization to the date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.|All randomized patients.||percentage of participants||95% Confidence Interval|Number
177913|NCT00003910|Secondary|Clinical Response||Assessed during the first 4 months of treatment and followed until reaching full study stop date||||||
177914|NCT00003910|Primary|Complete, Partial, and Overall Response Rates of Treatment With MTX, and Also With CY for Patients Failing to Respond to MTX|We will report the overall response rate below. Complete remission requires that all of the following be present for at least four weeks: The patient must have a normal CBC including neutrophil count > 1500/mm3, lymphocyte count< 4000/mm3, hemoglobin > 11 g/dl, and platelet count > 100,000/mm3. In addition, the patient must have a normal LGL count. A complete response will be attained if CD8+ cells were less than 760/mm³. A partial response will be defined as achievement of any one of the following in the absence of CR. The response must last for at least four weeks:In patients being treated for severe neutropenia (less than 500 neutrophils/mm3) an improvement to over 500 neutrophils/mm3 will be considered a partial response, as long as that improvement represents at least a 50% impr|Assessed during the first 4 months, then at least every three months for two years. Then every six months until five years after study entry, and every 12 months thereafter until full study stop date.|Of the 59 pts, 4 were ineligible and excluded from the analysis.||proportion of participants||95% Confidence Interval|Number
177915|NCT00003907|Secondary|Overall Survival|Overall survival was defined as time from registration to death from any causes.|Assessed every 3 months for 2 years, then every 6 months for 3 year.|all eligible and treated patients||Months||90% Confidence Interval|Median
177916|NCT00003907|Secondary|Tumor Response|Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as >= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response.|Assessed every 6 weeks|all eligible and treated patients||Proportion of participants||90% Confidence Interval|Number
177917|NCT00003907|Primary|Time to Progression|Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions|Assessed every 3 months for 2 years, then every 6 months for 3 year.|All eligible and treated patients||Months||90% Confidence Interval|Median
177918|NCT00003901|Secondary|Disease-Free Survival in Bone Marrow Examined Patients|Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM||years||95% Confidence Interval|Median
177919|NCT00003901|Secondary|Disease-Free Survival in Lymph Nodes Examined Patients|Disease-free survival was defined as the time period from registration to the date of first evidence recurrent disease in patients following curative pulmonary resection or death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants with N0 non–small-cell lung cancer who had underwent pulmonary resection and were examined for OM||years||95% Confidence Interval|Median
177920|NCT00003901|Primary|Overall Survival in Bone Marrow Examined Patients|Overall survival was defined as the time period between patient registration and death. Rib bone marrow on participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants who had underwent pulmonary resection with rib bone marrow were examined for OM||years||95% Confidence Interval|Median
177921|NCT00003901|Primary|Overall Survival in Lymph Nodes Examined Patients|Overall survival was defined as the time period between patient registration and death. All histologically negative lymph nodes (N0) participants were examined for occult metastases (OM), diagnosed by cytokeratin immunohistochemistry (IHC).|Up to 5 years|Eligible participants with N0 non–small-cell lung cancer who had underwent pulmonary resection and were examined for OM||years||95% Confidence Interval|Median
177922|NCT00003896|Secondary|Adverse Events|Only adverse events that are possibly, probably or definitely related to study drug are reported.|Weekly during 6 weeks of protocol treatment|Paclitaxel/CDDP/Liposomal doxorubicin||Participants|||Number
177923|NCT00003896|Primary|Overall Survival|from date of registration to date of death due to any cause. Patients last known to be alive wer censored at date of last contact|Weekly for 6 weeks, then every 6 months for 2 years, then annually thereafter.|All eligible patients who began the treatment intervention.||months||95% Confidence Interval|Median
177924|NCT00003896|Primary|Progression-free Survival|From date of registration to date of progression (as defined per RECIST), symptomatic deterioration or death due to any cause.|Once a month for 6 months, then every 6 months for up to 2 years, then annually thereafter.|Eligible patients who began the treatment intervention||months||95% Confidence Interval|Median
177971|NCT00003377|Secondary|Disease-free Survival at 2 Years|"Product-limit estimate of the probability of being alive and progression-free at 24 months based on those 20 patients who were treated at the study recommended dose level (RDL) is 0.65, 95% confidence interval (0.44-0.86).~Progression is defined as a 50% or greater increase in the product from any lesion documented within eight weeks for study entry or the appearance of any new lesion within eight weeks of entry into study."|2 years|||probability||95% Confidence Interval|Mean
177925|NCT00003869|Secondary|Number of Patients With a Confirmed Tumor Responses Treated With CAI.|"Confirmed response was defined as a complete response (CR) or partial response (PR) for patients with measurable disease or as a CR or regression (REGR) for patients with evaluable disease noted on 2 consecutive evaluations at least 4 weeks apart.~CR: total disappearance of all tumor;~PR: >=50% reduction of the sum of the products of the two greatest perpendicular diameters of all indicator lesions;~REGR: Definite decrease in tumor size and no new lesion(s)."|During Treatment (up to 5 years)|This data was not (and will never be) analyzed as it was not submitted consistently due to the trial design. (Patients were required to be SD or better to be randomized to carboxyamidotriazole or placebo.)|||||
177926|NCT00003869|Secondary|Clinically Significant (10-point) Decrease in Functional Assessment of Cancer Therapy for Lung Cancer (FACT-L) Quality of Life (QOL)Assessment From Baseline to Week 8|The FACT-L is a 36-item Likert instrument that combines frequency of symptomatic/QOL problems with perceived relative importance of each issue. It includes 4 constructs of well being: physical, social/family, emotional and functional, and a fifth construct, additional concerns, dealing solely with tumor related symptoms. Questionnaires were completed at baseline and 8 weeks. Questions within each construct were summated to obtain a construct score. A higher score relates to higher quality of life. A 10 point or greater decline (from baseline to week 8) was considered clinically significant.|Baseline to week 8|Participants who completed the baseline and week 8 FACT-L assessment are included in the analysis.||participants|||Number
177927|NCT00003869|Secondary|Clinically Significant (10-point) Decrease in UNISCALE Quality of Life (QOL)Assessment From Baseline to Week 8|The UNISCALE was used to assess QOL. UNISCALE is a single item global measure of QOL. Participant were to complete the questionnaire at baseline and every 8 weeks, prior to assessment by the treating physician. A high score indicates a higher quality of life while a low score represents a lower quality of life. A 10 point or greater decline (from baseline to week 8) in UNISCALE QOL score was considered clinically significant.|Baseline to week 8|Participants who completed the baseline and week 8 UNISCALE assessment are included in the analysis.||participants|||Number
177928|NCT00003869|Secondary|Time to Disease Progression (TTP)|"TTP is defined as the time from randomization to first documented disease progression(PD). Patients who were lost to follow-up were censored at the time of last evaluation. For patients who died without clear documentation, PD was assumed at the midpoint of the time interval between last evaluation and death. Median TTP was estimated using the Kaplan Meier method.~Measurable PD: ≥25% increase in the sum of the products of two greatest perpendicular diameters of all indicator lesions or appearance of new lesion(s). Evaluable PD: definite increase in tumor size or appearance of new lesion(s)"|up to 5 years|TTP was analyzed on all randomized patients on an intent to treat basis.||Months||95% Confidence Interval|Median
177929|NCT00003869|Secondary|Participants With Severe Non-hematologic Adverse Events|Severe non-hematologic adverse events were defined as adverse events grade 3 or higher, regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC version 2.0)|every cycle during treatment|All treated participants; all participants who received study treatment.||Participants|||Number
177930|NCT00003869|Primary|Overall Survival (OS)|OS was defined as the time from randomization to death of any cause. Participants who did not die or were lost to follow-up were censored at the time of last evaluation/follow-up date. Patients were followed for a maximum of 5 years from randomization. The median OS with 95%CI was estimated using the Kaplan Meier method.|up to 5 years|Overall survival was analyzed on all randomized participants on an intent to treat basis.||Months||95% Confidence Interval|Median
177931|NCT00003782|Secondary|Amenorrhea in Premenopausal Women||baseline, 9 weeks, and 6, 12, 18, and 24 months||||||
177932|NCT00003782|Secondary|Quality of Life Among Breast Cancer Patients||baseline, 9 weeks, and 6, 12, 18, and 24 months||||||
177933|NCT00003782|Secondary|Toxicities Among the 3 Regimens||9 years||||||
177934|NCT00003782|Primary|Disease Free Survival||time to event: breast cancer recurrence; second primary cancer; death from any cause as a first event||||||
177935|NCT00003782|Primary|Overall Survival||8 years|||percentage of patients alive|||Number
177936|NCT00003726|Primary|Dose, Safety and Antitumor Response Rate of Administering Recombinant Desulfato Hirudin, Elpirudin to Previously Treated Patients With Extensive or Recurrent Small Cell Lung Cancer|Evaluated through clinical exams, tumor assessments, laboratory assessment, and adverse event assessments.|18 months|No data were collected|||||
177937|NCT00003659|Secondary|Overall Survival Status|The 5 year survival rate|up to 5 years|All assessable patients as indicated in the protocol.||participants|||Number
177938|NCT00003659|Secondary|Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease|The flow cytometric response and the molecular polymerase chain reaction (PCR) response was captured as indicated in the protocol.|3 years|All assessable patients as indicated in the protocol||participants|||Number
177939|NCT00003659|Primary|Overall Response Rate|Response was determined as inicated in the protocol. The catergories are: complete response, nodular partial response, partial response and failure.|3 years|There were 36 assessable patients as described in the protocol||participants|||Number
177940|NCT00003641|Secondary|5-year Overall Survival Rate|Overall survival (OS) was defined as time from randomization to death from any cause. Patients still alive were censored at last known alive date. Kaplan-Meier method was used to estimate 5-year OS rate in the ITT patients.|assessed every 3 months for 2 years, every 6 months for 3 years|all randomized patients||proportion of participants||95% Confidence Interval|Number
177941|NCT00003641|Primary|5-year Relapse-free Survival Rate|Relapse-free survival (RFS) was defined as time from randomization to disease relapse or death from any cause, whichever occurred first. Patients without disease relapse were censored at last disease assessment date known of free of relapse. Kaplan-Meier method was used to estimate 5-year RFS rate in the intent-to-treat (ITT) patients.|assessed every 3 months for 2 years, every 6 months for 3 years|all randomized patients||proportion of participants||95% Confidence Interval|Number
177942|NCT00003631|Primary|Objective Response|Determine the overall objective response. CR rate [as measured from the start of ICE, (or high dose CTX) to the end of transplant for those who receive it, or the end of ICE for those who do not].Complete response (CR): No evidence of Hodgkin's disease determined clinically, radiologically or pathologically when indicated|2 years|||participants|||Number
177972|NCT00003377|Primary|Dose Limiting Toxicity(DLT)/Significant Dose Delay of Paclitaxel With Cisplatin as Assessed by CTC 2.0 After 6 Cycles of Treatment||up to 21 weeks|||participants|||Number
177943|NCT00003590|Secondary|Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drug|Adverse Events (AEs) are reported by CTC 2.0 terminology. For each patient, worst grade of each event type is reported. Grade 3 - Severe, Grade 4 - Life-threatening, Grade 5 - Fatal|Patients were assessed for adverse events 4 weeks after starting treatment. Assessments for adverse events continued every 3 months for the duration of protocol therapy. On average patients remained on therapy for 8 months|Eligible patients who had received any hydroxyurea were included in the adverse event summaries. Any CTC 2.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.||Participants with a given type of AE|||Number
177944|NCT00003590|Primary|Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)|Complete Response (CR)is a complete disappearance of all measurable and evaluable disease. No new lesions, no disease related symptoms, no evidence of non-evaluable disease. Partial Response (PR)is greater than or equal to 50% decrease under baseline in sum of the products of perpendicular diameters of all measurable lesions. No progression of evaluable disease, no new lesions. Confirmation of CR or PR means a repeat scan at least 3 weeks apart documented before progression. No response means that patient did not achieve complete or partial response (either confirmed or unconfirmed).|Patients treated for 2 years or progression. If responding can continue at physician's discretion.|All eligible patients who started treatment were included in assessing response estimates.||Participants|||Number
177945|NCT00003483|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months overall survival|6 months, 12 months, 24 months|All study subjects receiving any Antineoplaston therapy||Percentage of Participants|||Number
177946|NCT00003483|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months|||Participants|||Number
177947|NCT00003479|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of Participants|||Number
177948|NCT00003479|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months|||Participants|||Number
177949|NCT00003477|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
177950|NCT00003477|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks. Stable Disease (SD): <50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions and no Progressive Disease, sustained for at least four weeks. Progressive Disease (PD): >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months|||Participants|||Number
177951|NCT00003475|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
177952|NCT00003475|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months|||Participants|||Number
177953|NCT00003473|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
177954|NCT00003473|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months|||Participants|||Number
177955|NCT00003470|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
177973|NCT00003298|Secondary|Progression Free Survival|Progression-free survival (PFS) was defined as time from registration until progression, recurrence, or death, whichever occurred first. If date of death occurred beyond three months from the date of last disease assessment, then PFS was censored at date of last disease assessment. Patients who were alive and progression-free were censored at the date of last disease evaluation.|assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10|eligible and treated patients on step 1||years||90% Confidence Interval|Median
177956|NCT00003470|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), <50% decrease and <25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least eight weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.|12 months|||Participants|||Number
177957|NCT00003468|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
177958|NCT00003468|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks..|12 months|||Participants|||Number
177959|NCT00003460|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
177960|NCT00003460|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months|||Participants|||Number
177961|NCT00003459|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
177962|NCT00003459|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months|||Participants|||Number
177963|NCT00003458|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
177964|NCT00003458|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks.|12 months|||Participants|||Number
177965|NCT00003457|Secondary|Percentage of Participants Who Survived|6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival|6 months, 12 months, 24 months, 36 months, 48 months, 60 months|All study subjects receiving any Antineoplaston therapy||Percentage of participants|||Number
177966|NCT00003457|Primary|Number of Participants With Objective Response|Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks; Stable Disease (SD), < 50% decrease and < 25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least 8 weeks; Progressive Disease (PD), >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions compared to the lowest sum recorded.|12 months|||Participants|||Number
177967|NCT00003389|Secondary|Incidence of Second Cancers|Number of patients who developed second primary cancers|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years|||participants|||Number
177968|NCT00003389|Secondary|5-year Overall Survival|Overall survival is defined as the time from randomization to death or last known alive. The 5-year survival rate is the probability a patient survives 5 years.|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5, and yearly for 5 years|Eligible patients||Proportion of patients||95% Confidence Interval|Number
177969|NCT00003389|Primary|Failure-free Survival at 5 Years|"Failure-free survival is defined as the time from randomization to the earlier of progression/relapse or death. The 5-year failure-free survival is the probability a patient is failure-free and survives 5 years.~Progression is defined as an increase in size of 25% of the sum of the products of the pretreatment measurements or appearance of new lesions. Significant enlargement of the liver or spleen is evidence of progression. A significant increase in size is defined as > 2.0 cm in distance between costal margin and the inferior margin of either organ.~Relapse is defined as the re-appearance of any clinical evidence of Hodgkin's disease in a patient who has had a complete response. Relapse for partial responders is defined as progressive disease relative to disease status during the partial remission."|Assessed every 2 months if patient is < 1 year from study entry, every 3 months for the second year, every 4 months for the third year, every 6 months for years 4 and 5|Eligible patients||Proportion of patients||95% Confidence Interval|Number
177970|NCT00003377|Secondary|Overall Survival at 2 Years|Product-limit estimate of the probability of being alive at 24 months based on those 20 patients who were treated at the study recommended dose-level is 0.80, 95 % confidence interval (0.62-0.97)|2 years|||probability||95% Confidence Interval|Mean
177974|NCT00003298|Secondary|Overall Survival|Overall survival was defined as the time from registration to death, where a subject was censored on date of last record alive.|assessed every month for the first 3 months, every 3 months for the next 21 months, every 6 months for the next year, and annually thereafter up to year 10|eligible and treated patients on step 1||years||90% Confidence Interval|Median
177975|NCT00003298|Primary|Grade 3 or Higher Toxicity Incidence on Step 1|Incidence is defined as proportion of patients with any grade 3 or higher treatment-related toxicities among all treated patients.|assessed at the end of every cycle (cycle=21 days) during treatment (3 cycles in total)|eligible and treated patients on step 1||percentage of participants||95% Confidence Interval|Number
177976|NCT00003298|Secondary|Best Confirmed Response to Neoadjuvant Therapy|Response was based on pathology at surgery. A patient achieved complete response if no gross or microscopic tumor were identified with the surgical specimen and nodal tissue. Stable response was defined as a response that did not qualify as complete response or progressive disease (PD), where PD indicated metastatic spread. Best confirmed response rate was defined as the proportion of patients with complete response (CR). A patient was considered unevaluable if the patient did not have surgery, the pathologist did not examine at least 15 lymph nodes, or the pathology report was unavailable.|Assessed at surgery time (surgery performed during week 8-10 after registration to the study)|Eligible and treated patients on step 1. Since no patient had a complete response in the study, one-sided 95% confidence interval was provided here.||percentage of participants||95% Confidence Interval|Number
177977|NCT00003224|Other Pre-specified|Number of Participants With a Proliferative Response to Tetanus Helper Peptide|Proliferative response measured in participants using a tritiated thymidine incorporation assay with peripheral blood mononuclear cells (PBMC) stimulated with the tetanus peptide in vitro, and measured at 5 days after in vitro culture.|during vaccination|All evaluable enrolled patients were assayed.||participants|||Number
177978|NCT00003224|Secondary|Immunogenicity of Each Vaccine Regimen|T cell responses to the p946 (gp100 [280-288]) peptide. All enrolled patients were assayed for immune response to the gp100 peptide by ELIspot assay after 14 days in vitro sensitization. The number with a response in each study arm is reported.|up to 12 months since enrollment|||participants|||Number
177979|NCT00003224|Primary|Safety: Grade 3 Adverse Events|Adverse events are monitored according to NCI/DCT Common Toxicity Criteria|Up to 24 months after last vaccine|||participants|||Number
177980|NCT00003222|Primary|Measure of Tumor-antigen-specific Immunity in Sentinel Immunized Node (SIN) by Elispot Assay||Weeks 0-6,12; Months 6,12 and 24|Analysis of this outcome measure was performed on subjects in Stage I of the trial. Sentinel immunized nodes (SIN) were not evaluable for early tumor progression (5 arm 1, 2 arm 2) and patient refusal (1 arm 2). Thus, SINs were evaluable from 8 in arm 1 and 10 on arm 2, exceeding the protocol requirement for at least 6 subjects on each arm.||responders|||Number
177981|NCT00003222|Primary|Measure of Tumor-antigen-specific Immunity in Peripheral Blood Mononuclear Cells (PBMC) by Elispot Assay||Weeks 0-6,12; Months 6,12 and 24|The analysis of this outcome measure was performed on subjects enrolled in Stage I of the trial, which included 13 subjects in each arm. Some patients were not evaluable because of inadequate sample availability.||responders|||Number
177982|NCT00003222|Primary|Evaluation of Objective Clinical Response (CR/PR/SD)|The primary end point for this trial was clinical response. This was assessed by measurement of assessable metastatic deposits by CT, MRI, or direct measure of cutaneous deposits. Baseline tumor measurements used for assessment of clinical response were those obtained most immediately before the first vaccine administration and within 6 weeks of protocol entry. Measurements were made and reviewed by a multidisciplinary team. The original protocol defined tumor response on the basis of changes in cross-sectional area calculated as the product of two perpendicular measures. However, since the initiation of this study, the Response Evaluation Criteria in Solid Tumors Group (RECIST) system was employed as the current standard for clinical trials, in which response is based on changes in maximum cross-sectional dimensions. Computed tomography scans of clinical responders were reviewed again by a senior faculty radiologist not otherwise involved in the study.|Weeks 0-6,12; Months 6,12 and 24|The analysis of this outcome measure was performed on subjects enrolled in Stage I of the trial, which included 13 subjects in each arm.||participants|||Number
177983|NCT00003138|Secondary|Quality of Life- Total Functional Assessment of Cancer Therapy - General (FACT-G) Score at 4 Months|The FACT-G scale has 4 dimensions, including physical well-being, social/family well-being, emotional well-being, and functional well-being. The score for each subscale was added together to obtain the total FACT-G score that was evaluated on this study. The total FACT-G score ranges from 0 to 108 with higher scores reflecting better quality of life. It was administered at the time of study entry, every 4 months for the first year, and at the time patient went off treatment. Due to limited data after 4 months on treatment, the analysis was restricted to the four-month time point.|Assessed at 4 months|Only patients who completed quality of life assessment at 4 months were included in this analysis.||Scores on a scale||Standard Deviation|Mean
177984|NCT00003138|Secondary|Overall Survival|Time from randomization to death from any cause. Patients alive at the time of analysis were censored at the date of last contact.|Assessed every 3 months for 2 years, every 6 months for 3 subsequent years, and annually thereafter|All patients with complete data were included in this analysis.||Months||95% Confidence Interval|Median
177985|NCT00003138|Primary|Proportion of Patients Free of Transfusion at 4 Months|Whether a patient required transfusion or not at 4 months was recorded.|Assessed at 4 months|Only patients with transfusion data were included in this analysis.||Proportion of patients||95% Confidence Interval|Number
177986|NCT00002975|Primary|Response Rate||One Year|PI died, leaving incomplete data. Data not analyzed.|||||
177987|NCT00002931|Secondary|Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years.|||Months||95% Confidence Interval|Median
177988|NCT00002931|Primary|Toxic Effects|Grade 3 and 4 adverse events related to protocol-based therapy|Cycles 1 and 2|||participants|||Number
177989|NCT00002931|Primary|Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.|Until disease progression, up to 5 years.|||Months||95% Confidence Interval|Mean
177990|NCT00002850|Primary|Proportion of Patients Experiencing a Serious Bacterial Infection|This study evaluated the impact of prophylactic antibiotics on the incidence of serious bacterial infections (SBIs) during the first 2 months of treatment in patients with newly diagnosed multiple myeloma. Patients with multiple myeloma receiving initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin, trimethoprim-sulfamethoxazole, or observation and evaluated for SBI for the first 2 months of treatment.|First three months of chemotherapy|||percentage of participants||95% Confidence Interval|Number
177991|NCT00002766|Primary|Complete Remission (CR)|complete remission (CR) Disappearance of all clinical evidence of leukemia for a minimum of four weeks. The patient should have a neutrophil count > 1,000 x 10^6/1, a platelet count > 100,000 x 10^9/1, no circulating blasts, and < than or = to blasts on bone marrow differential in a qualitatively normal or hypercellular marrow. Progressive disease or failure: Increasing bone marrow infiltrate or development of organ failure or extramedullary infiltrates due to leukemia.|2 years|||participants|||Number
177992|NCT00002601|Secondary|5-year Overall Survival|Estimated using the product-limit method of Kaplan and Meier.|Until death from any cause, up to 5 years|||percentage of participants||95% Confidence Interval|Number
177993|NCT00002601|Secondary|5-year Progression-free Survival|Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 25% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions.|Until disease progression, up to 5 Years|||percentage of participants||95% Confidence Interval|Number
177994|NCT00002601|Primary|Evaluate the Toxicities of Two Cycles of Sequential High-dose Chemotherapy With Autologous Stem Cell Support.|Number of patients with grade 3 and 4 toxicities observed during cycle 1 and of HDCT related to sequential high-dose chemotherapy with autologous stem cell support using the Common Toxicity Criteria Version for Chemotherapy.|2 months after completion of second cycle of treatment.|||Participants|||Count of Participants
177995|NCT00002601|Primary|Evaluate the Feasibility of Administration of Two Cycles of High-dose Chemotherapy Followed by Autologous Stem Cell Support in Patients With High-risk or Advanced Sarcomas.|Criteria for early termination of this feasibility study: > 2 patients experience grade 4 or 5 hematologic toxicity or more that 3 patients experience grade 3 hematologic toxicity; > 2 patients experience grade 3 hepatic or gastrointestinal toxicity or > 3 patients are unable to receive the second cycle of treatment; > 2 patients experience grade 5 toxicity related to treatment regimen.|2 years after completion of treatment|||participants with Grade 3 Bilirubin|||Number
177996|NCT00002558|Primary|Overall Objective Response|Overall Objective Response will be assessed prior to dose-intensive therapy and at the completion of therapy. Complete disappearance of all clinical, radiographic and biochemical (normal AFP and HCG) evidence of disease for a minimum of 4 weeks (CR to chemotherapy). Patients must be free of disease for a minimum of 4 weeks. Partial Response: Complete disappearance of all biochemical evidence of disease in patients without a surgical procedure for a residual radiographic mass. Patients must demonstrate no biochemical recurrence or progression of radiographic masses for a minimum of four weeks (PR to chemotherapy}|2 years|||participants|||Number
177997|NCT00002540|Secondary|T5 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T5 (five years after entry)|All males in the Prostate Screening arm who had a PSA screen at T5 were analyzed.||Participants|||Number
177998|NCT00002540|Secondary|T4 PSA Screening Result|Prostate-Specific Antigen (PSA) result|T4 (four years after entry)|All males in the Prostate Screening arm who had a PSA screen at T4 were analyzed.||Participants|||Number
177999|NCT00002540|Primary|Prostate Cancer Death Rates|Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|||Deaths per 10,000 PY|||Number
178000|NCT00002540|Secondary|T3 DRE Screening Results|Digital Rectal examination (DRE) result|T3 (three years after entry)|All males in the Prostate Screening arm who had a DRE screen at T3 were analyzed.||Participants|||Number
178001|NCT00002540|Secondary|T3 PSA Screening Results|Prostate-Specific Antigen (PSA) result|T3 (three years after entry)|All males in the Prostate Screening arm who had a PSA screen at T3 were analyzed.||Participants|||Number
178002|NCT00002540|Secondary|T2 DRE Screening Results|Digital Rectal Examination (DRE) results|T2 (two years after entry)|All males in the Prostate Screening arm who had a DRE screen at T2 were analyzed.||Participants|||Number
178003|NCT00002540|Secondary|T2 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T2 (two years after entry)|All males in the Prostate Screening arm who had a PSA screen at T2 were analyzed.||Participants|||Number
178004|NCT00002540|Secondary|T1 DRE Screening Results|Digital Rectal Examination (DRE) result.|T1 (one year after entry)|All males in the Prostate Screening arm who had a DRE screen at T1 were analyzed.||Participants|||Number
178005|NCT00002540|Secondary|T1 PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T1 (one year after entry)|All males in the Prostate Screening arm who had a PSA screen at T1 were analyzed.||Participants|||Number
178006|NCT00002540|Secondary|T0 (Baseline) DRE Screening Results|Digital Rectal Examination (DRE) result.|T0 (at study entry)|All males in the Prostate Screening arm who had a DRE screen at T0 were analyzed.||Participants|||Number
178007|NCT00002540|Secondary|T0 (Baseline) PSA Screening Results|Prostate-Specific Antigen (PSA) result.|T0 (at study entry)|All males in the Prostate Screening arm who had a PSA screen at T0 were analyzed.||Participants|||Number
178008|NCT00002540|Secondary|Complications of Diagnostic Evaluation (DE) Following a Positive Screening Test|Number of positive screens with complications|One year from screening examination|The units analyzed were positive screening exams with documented diagnostic follow-up. If a participant received 3 positive screens with documented follow-up after each one, he would be counted 3 times in the number of units analyzed.||Positive screens w/ complications|Positive Screens with Follow-up||Number
178009|NCT00002540|Secondary|Prostate Cancer Incidence Rates|Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.||Diagnoses per 10,000 PY|||Number
178010|NCT00002540|Secondary|Prostate Cancer Incidence|Prostate cancer diagnoses confirmed by medical record abstraction. Incidence rate (cumulative) defined as prostate cancer diagnoses divided by person years at risk for prostate cancer.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
178011|NCT00002540|Secondary|Death Rates From All Causes|Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm. Rate is the number of deaths divided by person years of follow-up in the study.|Events through 13 years of follow-up or through December 31, 2009.|All male participants were analyzed. An intention-to-treat analysis was performed.||Deaths per 10,000 PY|||Number
178012|NCT00002540|Secondary|Deaths From All Causes|Deaths from all causes were compared between the prostate cancer screening arm and the usual care arm.|Events through 13 years of follow-up or through December 31, 2009.|All male participants were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
178013|NCT00002540|Primary|Prostate Cancer Deaths|Prostate cancer deaths confirmed in participants by a death review committee if available, otherwise by death certificate.|Events through 13 years of follow-up or through December 31, 2009; median follow-up 12.0 years.|All male participants randomized were analyzed. An intention-to-treat analysis was performed.||Participants|||Number
178014|NCT00002525|Secondary|5-year Disease-free Survival Rate in Patients With Dukes' B2 Disease|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B2 disease who had complete disease assessment data||proportion of participants||95% Confidence Interval|Number
178015|NCT00002525|Secondary|5-year Overall Survival Rate in Patients With Dukes' B2 Disease|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B2 disease||proportion of participants||95% Confidence Interval|Number
178016|NCT00002525|Secondary|5-year Disease-free Survival Rate in Patients With Dukes' B3/C Disease|Disease-free survival (DFS) was defined as time from randomization to recurrence, second invasive primary cancer, or deaths, whichever occurred first. Patients who were still alive and had no DFS events were censored at the last disease assessment date known to be free of DFS events. Patients without any follow up data were censored at random assignment. Kaplan-Meier method was used to estimate the 5-year DFS rate.|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B3 and C disease who had complete disease assessment data||proportion of participants||95% Confidence Interval|Number
178017|NCT00002525|Primary|5-year Overall Survival Rate in Patients With Dukes' B3/C Disease|Overall survival (OS) is defined as time from randomization to death from any cause or last date known alive. Kaplan-Meier method was used to estimate 5-year OS rate|every 3 months for 2 years, then every 6 months for 2 years, and then annually until year 15 after randomization|All randomized patients with Dukes' B3 and C disease||proportion of participants||95% Confidence Interval|Number
178018|NCT00001984|Secondary|Monocyte Count||4 day post operation|||cells/mm3||Full Range|Median
178019|NCT00001984|Primary|Rise in Serum Creatineine Above Posttransplant Nadir||24-32 days post operation|||parcentage rise in serum creatineine||Full Range|Median
178020|NCT00001984|Secondary|Creatinine at 2 Years|Creatinine level of donor recepient at 2 years after transplantation|2 years post operation|||mg/dL||Standard Deviation|Mean
178021|NCT00001984|Secondary|Creatinine Level at Year 1 Post Operation||1 year post operation|||mg/dL||Standard Deviation|Mean
178022|NCT00001984|Secondary|Creatinine Level at 6 Month Post Operation||6 month post operation|||mg/dL||Standard Deviation|Mean
178023|NCT00001984|Primary|Rejection Day of Onset|The day on which the rejection onsets.|From day 1 to 2 years post operation|||day||Full Range|Median
178024|NCT00001984|Primary|Number of Patients With Renal Allograft Rejection|The renal allograft tolerance was evaluated clinically, by flow cytometry, and by protocol biopsies analyzed immunohistochemically and with real-time polymerase chain reaction.|from day 1 to 24 months post operation|||participant|||Number
178025|NCT00001962|Secondary|Change in the Transfusion Requirements, Overall Survival.||3 and 6 months||||||
178026|NCT00001962|Primary|Daclizumab Hematologic Response|"Daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions to subjects diagnosed with moderate aplastic anemia (MAA), pure red cell aplasia (PRCA), Diamond Blackfan anemia (DBA), relapse and refractory severe aplastic anemia (SAA) will receive treatment. The Diamond Blackfan anemia arm was closed due to the lack of accrual. The hematologic response will be evaluated at 3 months.~A complete hematologic response will be considered an achievement of normal blood counts. A partial response was defined as any response less than a complete response. The primary endpoint was a hematologic response in at least one affected peripheral blood count parameter, as determined by 3 separate measurements in the first 12 weeks after completion of the infusion."|3 months|The daclizumab hematologic response was evaluated for subjects diagnosed with moderate aplastic anemia (MAA) and pure red cell aplasia (PRCA). The Diamond Blackfan arm was closed due to lack of accrual.||participants|||Number
178027|NCT00001959|Secondary|Proportion of Patients With Positive Change in GFR||12 months from baseline|||participants|||Number
178028|NCT00001959|Secondary|Proteinuria After Treatment||12 months from baseline|||g/d||Inter-Quartile Range|Median
178029|NCT00001959|Primary|Decrease in GFR During Treatment Period||12 months from baseline|ITT||ml/min/1.73 m2||Inter-Quartile Range|Mean
178030|NCT00001941|Primary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|12 months|Data is not available separately per cohort.||Participants|||Number
178116|NCT00000135|Primary|Mortality Rate|to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .|All patients enrolled were followed for a 17 month period or until a common study closing date|||deaths per person-year|||Number
178031|NCT00001941|Primary|Percentage of Participants With an Overall Response Rate|Participants overall response rate was defined as complete response (CR) + partial response (PR) from study consent until progression was measured. Responses was assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of >=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; and progressive disease is a >=25% increase in leukemic cell count|up to 220 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.||Percentage of participants|||Number
178032|NCT00001941|Primary|Overall Survival|Measured from the time the patient is consented until death.|132.6 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.||Weeks||95% Confidence Interval|Median
178033|NCT00001941|Primary|Duration of Response|Duration of response was defined as the interval from the time response is first achieved to the time progression from the best response is detected. Responses are assessed by a modified World Health Organization (WHO) criteria. Partial response is a reduction of >=50% saturation in the circulating leukemic cell count; complete response is disappearance of all measurable and non-measurable disease lasting more than 1 month; stable disease is patients who did not meet the criteria; and progressive disease is a >=25% increase in leukemic cell count.|21-220 weeks|Phase I is not reported because phase I studies only determine maximum tolerated dose.||Weeks||Full Range|Median
178034|NCT00001832|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.|10.5 months|||Participants|||Number
178035|NCT00001832|Primary|Clinical Response|Complete response (CR) is defined as the disappearance of all clinical evidence of disease. Partial response (PR) is a 50% or greater decrease in the sum of the products of perpendicular diameters of all measurable lesions for at least one month. No new lesions may appear, and none may increase. Minor response (MR) is a 25-49% decrease in the sum of the products of the perpendicular diameters of all measurable lesions. Appearance of new lesions following a PR or CR are considered relapses. Patients with progressive disease (PD) and no evidence of stable disease will be taken off study after receiving IL-2.|Every three to four weeks after the treatment, for up to 5 years.|||Participants|||Number
178036|NCT00001723|Secondary|Effect of Race on Change in Weight (kg)|Difference in change of weight in kg according to race (Non-Hispanic White versus Non-Hispanic Black)|baseline to 6 months|Multiple imputation analysis||kg||Standard Error|Mean
178037|NCT00001723|Secondary|Change in Body Fat (kg)|body fat distribution measures obtained from Dual-energy X-ray Absorptiometry (DEXA)|baseline to 6 months|Multiple Imputation analysis||kg||Standard Error|Mean
178038|NCT00001723|Secondary|Change in Body Mass Index|BMI is calculated in kg/m2. Change from baseline to 6 months of treatment|baseline to 6 months|Muliple imputation analysis||kg per square meter||Standard Error|Mean
178039|NCT00001723|Secondary|Change in Body Weight|Weight in kg|baseline to 6 months|Multiple imputation analysis||kg||Standard Error|Mean
178040|NCT00001723|Primary|Change in BMI Standard Deviation Score|Body Mass index standard deviation score calculated for age and sex according to Centers for Disease Control standards. See: Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z et al. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11 2002; (246): 1-190.|baseline to 6 months|Multiple imputation analysis||Standard Deviation Score||Standard Error|Mean
178041|NCT00001703|Secondary|The Number of Participants With Adverse Events.|Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|88 months|||participants|||Number
178042|NCT00001703|Primary|Percentage of Participants Who Generated an Immune Response|The immunological response was assessed by in-vitro T cell cytokine production enzyme-linked immunosorbent spot (ELISPOT). From each patients, post-vaccination peripheral blood mononuclear cells (PBMC) were compared to pre-vaccination as a baseline. A positive ELISPOT result for the patients was defined as a total number of experimental spots in the post-vaccination sample of more than twofold above the total spots in the pre-vaccination sample.|30 months|||percentage of participants|||Number
178043|NCT00001656|Other Pre-specified|Change in Extrapyramidal Movements as Measured by the Simpson Angus Scale Score|minimum score = 10; maximum score = 90; lower score considered a more favorable outcome|8 week double-blind study period; baseline and 8 weeks|||scores on a scale||95% Confidence Interval|Median
178044|NCT00001656|Other Pre-specified|Change in Extrapyramidal Movements as Measured by the Abnormal Involuntary Movements Scale (AIMS)|minimum score = 10; maximum score = 50; lower score is considered a more favorable outcome|8 week double-blind study period; baseline and 8 weeks|||scores on a scale||Full Range|Median
178045|NCT00001656|Other Pre-specified|Change in Body Mass Index (BMI)|BMI is calculated by the following formula: weight (in kilograms) divided by the square of the height (in meters)|8 week double-blind study period; baseline and 8 weeks|||kg/m²||Standard Deviation|Mean
178046|NCT00001656|Other Pre-specified|Change in Weight||8 week double-blind study period; baseline and 8 weeks|||kilograms||Standard Deviation|Mean
178047|NCT00001656|Primary|Change in the Bunney-Hamburg Rating Scale for Anxiety|Measures change in the severity of anxiety; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
178048|NCT00001656|Primary|Change in Bunney-Hamburg Rating Scale for Mania|Measures change in the severity of mania; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
178049|NCT00001656|Primary|Change in Bunney-Hamburg Rating Scale for Depression|Measures change in severity of depression; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
178050|NCT00001656|Primary|Change in the Bunney-Hamburg Rating Scale for Psychosis|Measures change in psychosis severity; Minimum score = 0; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
178051|NCT00001656|Primary|Change in the Scale for the Assessment of Positive Symptoms|Measures change in hallucinations, delusions, bizarre behavior, and thought organization. Minimum score = 0; maximum score = 170; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
178052|NCT00001656|Primary|Change in the Brief Psychiatric Rating Scale-24|A 24-item scale measuring change in interpersonal behaviors, mood, psychosis, anxiety, speech, sleep, orientation and physical activity. Lowest score = 24; highest score = 168; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
178053|NCT00001656|Primary|Change in the Clinical Global Impression Severity of Symptoms Scale|Measures change in the severity of symptoms; Minimum score = 1; maximum score = 7; lower score is considered a better outcome.|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
178054|NCT00001656|Primary|Change in the Scale for the Assessment of Negative Symptoms|Measures change in affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, attention; minimum score = 0; maximum score = 125; lower values are considered a better outcome|8 week double-blind study period; baseline and 8 weeks|||Scores on a scale||95% Confidence Interval|Mean
178055|NCT00001596|Secondary|Change in 6 Minute Walk Test (12 Months)|Change from baseline of the 6 minute walk test (6MWT) at 12 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data is available at baseline and 12 months.||meters||Standard Deviation|Mean
178056|NCT00001596|Secondary|Change in 6 Minute Walk Test (36 Months)|Change from baseline of the 6 minute walk test (6MWT) at 36 months. The 6MWT measures the distance that a patient can quickly walk on a flat hard surface in a period of six minutes.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data is available at baseline and 36 months.||meters||Standard Deviation|Mean
178057|NCT00001596|Secondary|Change in Adjusted Diffusing Capacity of the Lung for Carbon Monoxide (12 Months)|Change from baseline in adjusted Diffusing Capacity of the lung for carbon monoxide (DLCOa) measured at 12 months. DLCOa measures gas uptake during a single inspiration in a standard time, adjusted for subject's hemoglobin levels.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data is available at baseline and 12 months.||% of predicted volume||Standard Deviation|Mean
178058|NCT00001596|Secondary|Change in Adjusted Diffusing Capacity of the Lung for Carbon Monoxide (36 Months)|Change from baseline in adjusted Diffusing Capacity of the lung for carbon monoxide (DLCOa) measured at 36 months. DLCOa measures gas uptake during a single inspiration in a standard time, adjusted for subject's hemoglobin levels.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data was available at baseline and 36 months.||% of predicted volume||Standard Deviation|Mean
178059|NCT00001596|Secondary|Change in Total Lung Capacity (12 Months)|Change from baseline in Total Lung Capacity (TLC) measured at 12 months. TLC is the volume in the lungs at maximal inflation. TLC is recorded as the percentage of predicted volume based on subject's height, age, sex, and weight.|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data was available at baseline and 12 months.||% of predicted volume||Standard Deviation|Mean
178060|NCT00001596|Secondary|Change in Total Lung Capacity (36 Months)|Change from baseline in Total Lung Capacity (TLC) measured at 36 months. TLC is the volume in the lungs at maximal inflation. TLC is recorded as the percentage of predicted volume based on subject's height, age, sex, and weight.|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data is available at baseline and 36 months.||% of predicted volume||Standard Deviation|Mean
178061|NCT00001596|Secondary|Change in Forced Vital Capacity (12 Months)|Change from baseline in the Forced Vital Capacity (FVC) measurement at 12 months. FVC is the volume of air that can be forcibly blown out from the lungs after full inspiration. FVC is recorded as the percentage of predicted volume (predicted FVC volume is calculated based on subject's height, age, sex, and weight).|Measured at baseline and 12 months|Participants from the Intent to Treat population for whom data was available at baseline and 12 months.||% of predicted volume||Standard Deviation|Mean
178062|NCT00001596|Primary|Change in Forced Vital Capacity (36 Months)|Change from baseline in the Forced Vital Capacity (FVC) measurement at 36 months. FVC is the volume of air that can be forcibly blown out from the lungs after full inspiration. FVC is recorded as the percentage of predicted volume (predicted FVC volume is calculated based on subject's height, age, sex, and weight).|Measured at baseline and 36 months|Participants from the Intent to Treat population for whom data was available at baseline and 36 months.||% of predicted volume||Standard Deviation|Mean
178063|NCT00001586|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|13 years, 10.5 months|The low-intermediate risk patients received no treatment so their tissue/blood was not analyzed for change.||Participants|||Number
178064|NCT00001586|Primary|Change in Gene Expression Post Chemo|Changes in lymphocyte gene expression was measured by deoxyribonucleic acid (DNA) microarray analysis of circulating leukemic cells after completion of study treatment. A change in expression is defined as a >50% increase in circulating leukemic cells or a 30% decrease in circulating leukemic cells.|6 hours post treatment, and 24 hours post treatment|There were only 12 patients analyzed for various reasons such as timing of treatment, ability to collect samples, and viability of samples.||Percent change in cells|||Number
178065|NCT00001575|Secondary|Number of Participants With Adverse Events|Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.|16 yrs 18 days|||participants|||Number
178079|NCT00001304|Secondary|Serum Phosphorus Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.7-1.4. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||mmol/liter||Standard Deviation|Mean
178080|NCT00001304|Secondary|Serum Magnesium Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 0.65-1.05. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||mmol/liter||Standard Deviation|Mean
178066|NCT00001575|Primary|Clinical Response|Clinical Response of patient is measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Tumor responses were evaluated by In-HAT imaging (i.e., simultaneous with administration of therapeutic 90Y-daclizumab), Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scans and computed tomography (CT) scans. Complete response is a disappearance of all measurable and evaluable disease lasting more than I month. Partial response is a reduction by ≥ 50% of leukemic cell count or ≥ 50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesions for 1 month. Stable disease is less than partial response with no more than a 25% increase in leukemic cell count, no new lesions, or less than a 25% increase in any measurable lesion. Progressive disease is at least a 25% increase in leukemic cell count, appearance of new lesions, or an increase of 25% or greater in any measurable lesion after 2 weeks.|Patient would be measured with computed tomography (CT) scan, Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scan in 28 days before treatment. Patient would be evaluated with In-HAT imaging at Day 1,4,5,6 and Day 7 in week 1 of each cycle.|Phase II portion. Only the Hodgkin's participants was analyzed (i.e., added more Hodgkins participants to study).||participants|||Number
178067|NCT00001575|Primary|Maximum Tolerated Dose (MTD) of 90Y-HAT|Phase I portion maximum tolerated dose (MTD) is defined as the dose level below the dose at which 2 out of 2-6 patients develop DLT (if any patient develops grade IV toxicity of any type (excluding grade IV neutropenia) or grade III non-hematologic toxicity that patient may not continue on the study at the same dose level and therefore has had a dose limiting toxicity). There can be no more than 1 out of 6 patients with DLT at the MTD. The MTD will be assessed using only the results from the first cycle of therapy.|Patients could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks.|Phase I portion-maximum tolerated dose. Only the Hodgkin's participants was analyzed (i.e., 28).||mci|||Number
178068|NCT00001566|Secondary|Median Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|5.4 years|||Years||Full Range|Median
178069|NCT00001566|Primary|Number of Participants With an Immune Response to Tumor-Specific Peptides at the Time of Presentation|Immune response was defined as a percent specific lysis of >10% following challenge with tumor peptide pulsed targets, or interferon gamma production following challenge with tumor peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0 to tumor peptide targets.Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. See protocol link module for additional information re: peptides.|Once per enrollment|||Participants|||Number
178070|NCT00001566|Primary|Number of Participants With an Immune Response to Non-Tumor-specific Peptide E7|Immune response was defined as a percent specific lysis of >10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0.|5 years|12 patients were human leukocyte antigen serotype within HLA-A A serotype group (HLA-A2+) and therefore evaluable for response to E7 peptides.||Participants|||Number
178071|NCT00001566|Secondary|Number of Participants With Adverse Events|Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.|5 years|||Participants|||Number
178072|NCT00001566|Secondary|Percent of Participants: Event Free Survival|Event free survival is calculated from the date of diagnosis for patients enrolled with newly diagnosed metastatic disease and from the date of the last recurrence detection before enrollment on this study for patients with recurrent disease.|5 years|||Percentage of participants|||Number
178073|NCT00001566|Secondary|Percentage of Participants Overall Survival|Overall survival is defined as the time between the first day of treatment to the day of death.|5 years|||Percentage of participants|||Number
178074|NCT00001566|Primary|Number of Participants With an Immune Response to the Translocation Breakpoint Peptide|Immune responses were measured following 3 sequential influenza vaccines during the same period as the peptide-pulsed dendritic cell vaccines.|5 years|||Participants|||Number
178075|NCT00001566|Primary|The Percent of Patients Who Recover CD4 Counts Within 6 Months of Completion of Chemotherapy|CD4 counts were measured from peripheral blood using standard flow cytometric techniques at the following timepoints: 2 months post-chemotherapy, 4 months post-chemotherapy and 6 months post-chemotherapy. To be eligible for evaluation for this endpoint, patient much have been <10 years of age and sustained a CD4 count of <300 cells/mcl upon completion of standard therapy. Recovery was defined as a CD4 count > 500 cells/mcl at any timepoint within 6 months of completing chemotherapy.|2 to 6 months|||Percentage of participants|||Number
178076|NCT00001566|Primary|Number of Participants With an Immune Response to Tumor-specific and Non-tumor Specific Peptides During a Period of Immune Reconstitution|Immune response was defined as a percent specific lysis of >10% following challenge with peptide pulsed targets, or interferon gamma production following challenge with peptide pulsed targets >2-fold that found with no-peptide controls or a proliferation index >3.0. Tumor specific peptides: Ewings sarcoma Type 1: EF-1 (EWS/FLI-1)*SSSYGQQN/PSYDSVRRGA,Ewing's Sarcoma Type 2: EF-2 (EWS/FLI-2)* SSSYGQ/QSSLLAYNT, Alveolar rhabdomyosarcoma: PXFK (PAX3/FKHR)† TIGNGLSPQ/NSIRHNLSL. Non-tumor specific peptide:HPV16E7 MLDLQPETT-MET-9-THR. See protocol link module for additional information re: peptides.|20 weeks post vaccination|||Participants|||Number
178077|NCT00001304|Primary|Urine Calcium Excretion Level|Measurements were taken1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/24 h, normal range 1.25-6.25. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||mmol/24 h||Standard Deviation|Mean
178078|NCT00001304|Secondary|Urinary Creatinine Clearance|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ml/min, normal range 90-125. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||ml/min||Standard Deviation|Mean
178081|NCT00001304|Primary|Serum Calcium Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = mmol/liter, normal range 2.05-2.5. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||mmol/liter||Standard Deviation|Mean
178082|NCT00001304|Secondary|Serum 25-hydroxyvitamin D Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = ng/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||ng/ml||Standard Deviation|Mean
178083|NCT00001304|Secondary|Serum 1,25-hydroxyvitamin D Level|Measurements were taken 1 hour before the morning dose of PTH or, calcitriol and calcium; UOM = pg/ml. Measurements were obtained on three successive days (three separate measures) semiannually at the NIH CC for each protocol subject. The average data are the average of these three semi-annual data points for each subject which are then averaged across all the semi-annual means for all subjects within each arm over the three years of study.|3 years|All patients on the study||pg/ml||Standard Deviation|Mean
178084|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Head Circumference Percentile||36 months or death|||Other - Percentile||Standard Deviation|Mean
178085|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Length Percentile||36 months or death|||Other - Percentile||Standard Deviation|Mean
178086|NCT00001262|Secondary|Somatic Growth Percentiles at 3 Years of Age (or at Age of Death) - Weight Percentile||36 months or death|||Other - Percentile||Standard Deviation|Mean
178087|NCT00001262|Primary|Language Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate language development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death|||Other - Months||Standard Deviation|Mean
178088|NCT00001262|Primary|Personal-Social Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate personal-social development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death|||Other - Months||Standard Deviation|Mean
178089|NCT00001262|Primary|Fine Motor Adaptive Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate fine motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death|||Other - Months||Standard Deviation|Mean
178090|NCT00001262|Primary|Gross Motor Development at 36 Mos of Age or at Death (Mos)|This was measured based on the Denver Developmental Screening Test (DDST) I or II for age-appropriate gross motor development in apparently normal healthy subjects at specific ages (in months). The DDST employs a grid to assess expected developmental milestones in relation to chronologic age.|36 months or death|||Other - months||Standard Deviation|Mean
178091|NCT00001213|Primary|Number of Eyes With a Corneal Cystine Crystal Score (CCCS) Response|"Response is defined as a decrease from baseline of at least 1 in Corneal Cystine Crystal Score (CCCS) at any time on study when baseline CCCS is greater than or equal to 1, or CCCS does not increase at least 1 at any time on study when baseline CCCS is less than 1.~The CCCS is based on a library of slit-lamp photographs of corneas with increasing crystal densities (0-3). Slit-lamp photos were to be taken to assess the extent of the corneal crystal accumulation. To minimize bias when assessing the extent of corneal crystal accumulation, photos were centrally graded at the National Eye Institute (NEI) where each photo was graded independently by masked graders. If more than one CCCS was recorded in a given study year, the highest (worst) CCCS value was used for that year.~The results were obtained from a combined analyses of the NIH cysteamine studies evaluating various cysteamine ophthalmic solution formulations from 1986 through 2005."|Any Time Point Up to 19 Years|One hundred sixty-one (161) participants were analyzed in the pre-specified intent-to-treat population [defined as patients who received study medication (between 1986 and 2005), and had a baseline and a post-baseline CCCS value]. After 2005, all participants enrolled received open-label treatment and only safety data was obtained.||eyes|Participants||Number
178092|NCT00001213|Primary|Number of Participants With Serious and Non-Serious Adverse Events|Since efficacy of ophthalmic cysteamine was established and a New Drug Application (NDA) filed, the post-hoc primary outcome measure is the evaluation of safety information. There was no specified time frame for this outcome measure, as safety data was being collected until the drug became available for commercial purchase in May 2013.|Any Time Point up to 27 Years|||participants|||Number
178093|NCT00001151|Primary|Number of Participants With Normal Serum Calcium Concentrations|Normal calcium concentration 8.2-10.6 mg/dL|1 year average|||participants|||Number
178094|NCT00000620|Secondary|First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior occurrence of event.||participants|||Number
178095|NCT00000620|Primary|First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.||participants|||Number
178096|NCT00000620|Secondary|Stroke in the Blood Pressure Trial.|Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of stroke.||participants|||Number
178097|NCT00000620|Primary|First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.|Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial.|4.7 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.||participants|||Number
178098|NCT00000620|Secondary|Death From Any Cause in the Glycemia Trial.|"Time to death from any cause. Secondary measure for Glycemia Trial.~A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid)."|4.9 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to death.||participants|||Number
178099|NCT00000620|Primary|First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.|"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial).~In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion."|4.9 years|The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE.||participants|||Number
178100|NCT00000575|Secondary|Standardized Depression Scale -- Children's Depression Inventory|Change in total score on the Children's Depression Inventory from baseline to the end of treatment, 4-6 years later. The total score ranges from 0-54 with higher scores indicating greater levels of depression.|4-6 years from baseline|||units on a scale||Standard Deviation|Mean
178101|NCT00000575|Secondary|Change in Height From Baseline to End of Treatment, 4-6 Years Later|Change in standing height from baseline to end of treatment. Standing height is measured three times without shoes using a calibrated Harpenden stadiometer; the average of the three repeated heights to the nearest 0.1 cm is the height measure at either baseline or end of treatment.|4-6 years from baseline|||cm||Standard Deviation|Mean
178102|NCT00000575|Secondary|Mortality|Counts of deaths from asthma.|4-6 years from baseline|||participants|||Number
178103|NCT00000575|Secondary|Need for Urgent Care for Asthma|Counts during the period of treatment (4-6 years) of visits to emergency rooms or equivalent urgent care settings for asthma treatment.|4-6 years from baseline|||rate per 100 person years|||Number
178104|NCT00000575|Secondary|Change From Baseline in the Rate of Asthma Free Days|Change from baseline proportion of days without asthma symptoms or other asthma related events to proportion of days during the 4-6 years of follow-up. Asthma free days were determined from daily asthma diaries kept from baseline to the end of treatment, 4-6 years later.|4-6 years from baseline|||days per month||Standard Deviation|Mean
178105|NCT00000575|Secondary|Bronchial Responsiveness to Serial Methacholine Concentrations Inhaled Into the Lungs|Bronchial responsiveness to serial concentrations of inhaled methacholine solution (mg/ml) as measured by serial ratios of follow-up to baseline FEV1 (forced volume of air expired from the lungs in one second). A dose-response curve is calculated from the serial ratios in relation to the serial concentrations to determine PC20, the concentration associated with a 20% drop from baseline in FEV1; this PC20 is the outcome measure with units mg/ml of methacholine.|4-6 years from baseline|||mg/ml of methacholine||Standard Deviation|Geometric Mean
178106|NCT00000575|Primary|Pulmonary Function as Measured by Normalized FEV1 Over a 4-6 Year Period|Change in FEV1 % of predicted, post-bronchodilator use, from baseline to the end of treatment (4-6 years after randomization). Percent predicted determined from three separate published sets of reference equations for white, black, and Hispanic children - see NEJM 343: 1054-1062, 2000 for more details and references.|At the end of treatment, 4-6 years from baseline assessment|||percentage of predicted value||Standard Deviation|Mean
178107|NCT00000479|Primary|Number of Participants With Cancer, Excluding Nonmelanoma Skin Cancer||Average follow-up 10.1 years|||participants|||Number
178108|NCT00000479|Primary|Number of Participants With Major Cardiovascular Events (a Combined Endpoint of Nonfatal Myocardial Infarction, Nonfatal Stroke, and Total Cardiovascular Death)||Average follow-up 10.1 years|||Participants|||Number
178109|NCT00000392|Secondary|Change in Neurocognitive Performance Domain z Scores From Baseline|Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)|Baseline and 6 months|||z score||Standard Error|Mean
178110|NCT00000392|Primary|Change in Global Neurocognitive Performance z Score From Baseline|Higher values for change in z-score represent an improvement in Neurocognitive Performance (NP)|Baseline and 6 months|||z score||Standard Error|Mean
178111|NCT00000378|Primary|HAMILTON Rating Scale for DEPRESSION Range|Hamilton scale range 0-40, values below 7 are considered normal. the higher the number the more severe the depression weekly assessments, The primary outcome is a comparison of the baseline Hamilton to the 12 week measurement|BASELINE COMPARED TO 12 WEEK MEASUREMENT|intent to treat analysis||units on a scale||Standard Deviation|Mean
178112|NCT00000371|Primary|Scale for the Assessment of Negative Symptoms (SANS)|The slope of SANS total score from baseline to week 8 in the treatment and placebo groups on the scale for the assessment of negative symptoms (SANS) total score. Total SANS scores range from 0-100. The SANS is comprised of 5 subscores: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each scale, the higher the score the more prominent the negative symptoms were. The slopes were obtained by plotting the group SANS total score mean for treatment vs. placebo on Baseline, Week 4, and Week 8 and performing a random slopes model.|Baseline, Week 4, Week 8|||units on a scale/weeks||Standard Error|Mean
178113|NCT00000143|Primary|Survival||3 years|||participants|||Number
178114|NCT00000142|Primary|Survival||All patients enrolled will be followed until a common study closing date|||participants|||Number
178117|NCT00000134|Primary|Morbidity|To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.|Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial|||participants|||Number
178118|NCT00000125|Primary|Incidence of Primary Open-Angle Glaucoma in Hypotensive Patients|Comparison of the cumulative proportion of participants who develop primary open-angle glaucoma in the observation and medication groups.|5 yrs (OHTS I, June 2002) and 13.0 yrs (completion of both phases of OHTS, March 2009)|1636 ocular hypertensive participants were randomized to either close observation or treatment with topical hypotensive eyedrops from February 1994 through June 2002. In June 2002 the observation participants were offered treatment with topical hypotensive eyedrops.||percent of participants|||Number
